Trial Comparing Tiotropium Inhalation Capsules vs Placebo in Chronic Obstructive Pulmonary Disease (COPD).

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00523991
First received: July 9, 2007
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

A 24 week, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 18mcg of tiotropium inhalation capsules administered by Handihaler once daily plus Pro Re Nata (PRN) albuterol (salbutamol) vs. placebo plus PRN albuterol (salbutamol) in chronic obstructive pulmonary disease subjects naive to maintenance therapy.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: tiotropium
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A 24 Week, Randomized, Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of 18 MCG of Tiotropium Inhalation Capsules Administered by HandiHaler Once-daily Plus PRN Albuterol (Salbutamol) vs. Placebo Plus PRN Albuterol (Salbutamol) in Chronic Obstructive Pulmonary Disease Subjects Naive to Maintenance Therapy

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Change From Baseline in Lung Function as Measured by the Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve From 0-3h (AUC0-3h) [ Time Frame: baseline, week 24 ] [ Designated as safety issue: No ]
    Change = Week 24 Value - Baseline Value


Secondary Outcome Measures:
  • Trough Forced Expiratory Volume in 1 Second (FEV1)(Baseline) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.

  • Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 8) [ Time Frame: Baseline, week 8 ] [ Designated as safety issue: No ]
    Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.

  • Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 16) [ Time Frame: Baseline, week 16 ] [ Designated as safety issue: No ]
    Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.

  • Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 24) [ Time Frame: Baseline, week 24 ] [ Designated as safety issue: No ]
    Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.

  • Peak Forced Expiratory Volume in 1 Second (Baseline) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1.

  • Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 8) [ Time Frame: Baseline, week 8 ] [ Designated as safety issue: No ]
    Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.

  • Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16) [ Time Frame: Baseline, week 16 ] [ Designated as safety issue: No ]
    Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.

  • Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24) [ Time Frame: Baseline, week 24 ] [ Designated as safety issue: No ]
    Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.

  • Forced Expiratory Volume in 1 Second (Baseline, Pre-dose) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Forced expiratory volume in 1 second (baseline, pre-dose)

  • Forced Expiratory Volume in 1 Second (Baseline, 30 Minutes) [ Time Frame: baseline, 30 minutes ] [ Designated as safety issue: No ]
    Forced expiratory volume in 1 second (baseline, 30 minutes)

  • Forced Expiratory Volume in 1 Second (Baseline, 60 Minutes) [ Time Frame: baseline, 60 minutes ] [ Designated as safety issue: No ]
    Forced expiratory volume in 1 second (baseline, 60 minutes)

  • Forced Expiratory Volume in 1 Second (Baseline, 120 Minutes) [ Time Frame: Baseline, 120 minutes ] [ Designated as safety issue: No ]
    Forced expiratory volume in 1 second (baseline, 120 minutes)

  • Forced Expiratory Volume in 1 Second (Baseline, 180 Minutes) [ Time Frame: Baseline, 180 minutes ] [ Designated as safety issue: No ]
    Forced expiratory volume in 1 second (baseline, 180 minutes)

  • Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, Pre-dose) [ Time Frame: baseline, week 8, pre-dose ] [ Designated as safety issue: No ]
    Change from baseline in forced expiratory volume in 1 second (at week 8, pre-dose)

  • Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 30 Minutes) [ Time Frame: Baseline, week 8, 30 minutes ] [ Designated as safety issue: No ]
    Change from baseline in forced expiratory volume in 1 second (at week 8, 30 minutes)

  • Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 60 Minutes) [ Time Frame: baseline, week 8, 60 minutes ] [ Designated as safety issue: No ]
    Change from baseline in forced expiratory volume in 1 second (at week 8, 60 minutes)

  • Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 120 Minutes) [ Time Frame: baseline, week 8, 120 minutes ] [ Designated as safety issue: No ]
    Change from baseline in forced expiratory volume in 1 second (at week 8, 120 minutes)

  • Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 180 Minutes) [ Time Frame: baseline, week 8, 180 minutes ] [ Designated as safety issue: No ]
    Change from baseline in forced expiratory volume in 1 second (at week 8, 180 minutes)

  • Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 16, Pre-dose) [ Time Frame: baseline, week 16, pre-dose ] [ Designated as safety issue: No ]
    Change from baseline in forced expiratory volume in 1 second (at week 16, pre-dose)

  • Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 30 Minutes) [ Time Frame: Baseline, week 16, 30 minutes ] [ Designated as safety issue: No ]
    Change from baseline in peak forced expiratory volume in 1 second (at week 16, 30 minutes)

  • Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 60 Minutes) [ Time Frame: baseline, week 16, 60 minutes ] [ Designated as safety issue: No ]
    Change from baseline in peak forced expiratory volume in 1 second (at week 16, 60 minutes)

  • Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 120 Minutes) [ Time Frame: baseline, week 16, 120 minutes ] [ Designated as safety issue: No ]
    Change from baseline in peak forced expiratory volume in 1 second (at week 16, 120 minutes)

  • Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 180 Minutes) [ Time Frame: baseline, week 16, 180 minutes ] [ Designated as safety issue: No ]
    Change from baseline in peak forced expiratory volume in 1 second (at week 16, 180 minutes)

  • Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, Pre-dose) [ Time Frame: baseline, week 24, pre-dose ] [ Designated as safety issue: No ]
    Change from baseline in peak forced expiratory volume in 1 second (at week 24, pre-dose)

  • Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 30 Minutes) [ Time Frame: baseline, week 24, 30 minutes ] [ Designated as safety issue: No ]
    Change from baseline in peak forced expiratory volume in 1 second (at week 24, 30 minutes)

  • Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 60 Minutes) [ Time Frame: baseline, week 24, 60 minutes ] [ Designated as safety issue: No ]
    Change from baseline in peak forced expiratory volume in 1 second (at week 24, 60 minutes)

  • Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 120 Minutes) [ Time Frame: baseline, week 24, 120 minutes ] [ Designated as safety issue: No ]
    Change from baseline in peak forced expiratory volume in 1 second (at week 24, 120 minutes)

  • Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 180 Minutes) [ Time Frame: baseline, week 24, 180 minutes ] [ Designated as safety issue: No ]
    Change from baseline in peak forced expiratory volume in 1 second (at week 24, 180 minutes)

  • FVC AUC0-3 at Baseline [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h)

  • FVC AUC0-3 at Week 8 Minus Baseline [ Time Frame: baseline, week 8 ] [ Designated as safety issue: No ]
    Change from baseline in Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h) (week 8)

  • FVC AUC0-3 at Week 16 Minus Baseline [ Time Frame: baseline, week 16 ] [ Designated as safety issue: No ]
    Change from baseline in Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h)(week 16)

  • FVC AUC0-3 at Week 24 Minus Baseline [ Time Frame: baseline, week 24 ] [ Designated as safety issue: No ]
    Change from baseline in Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h) (week 24)

  • Trough Forced Vital Capacity (Baseline) [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.

  • Change From Baseline in Trough Forced Vital Capacity (at Week 8) [ Time Frame: baseline, week 8 ] [ Designated as safety issue: No ]
    Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.

  • Change From Baseline in Trough Forced Vital Capacity (at Week 16) [ Time Frame: baseline, week 16 ] [ Designated as safety issue: No ]
    Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.

  • Change From Baseline in Trough Forced Vital Capacity (at Week 24) [ Time Frame: baseline, week 24 ] [ Designated as safety issue: No ]
    Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.

  • Peak Forced Vital Capacity (FVC) (Baseline) [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1.

  • Change From Baseline in Peak Forced Vital Capacity (at Week 8) [ Time Frame: baseline, week 8 ] [ Designated as safety issue: No ]
    Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.

  • Change From Baseline in Peak Forced Vital Capacity (at Week 16) [ Time Frame: baseline, week 16 ] [ Designated as safety issue: No ]
    Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.

  • Change From Baseline in Peak Forced Vital Capacity (at Week 24) [ Time Frame: baseline, week 24 ] [ Designated as safety issue: No ]
    Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.

  • Forced Vital Capacity (Baseline, Pre-dose) [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Forced vital capacity (baseline, pre-dose)

  • Forced Vital Capacity (Baseline, 30 Minutes) [ Time Frame: baseline, 30 minutes ] [ Designated as safety issue: No ]
    Forced vital capacity (baseline, 30 minutes)

  • Forced Vital Capacity (Baseline, 60 Minutes) [ Time Frame: baseline, 60 minutes ] [ Designated as safety issue: No ]
    Forced vital capacity (baseline, 60 minutes)

  • Forced Vital Capacity (Baseline, 120 Minutes) [ Time Frame: baseline, 120 minutes ] [ Designated as safety issue: No ]
    Forced vital capacity (baseline, 120 minutes)

  • Forced Vital Capacity (Baseline, 180 Minutes) [ Time Frame: baseline, 180 minutes ] [ Designated as safety issue: No ]
    Forced vital capacity (baseline, 180 minutes)

  • Change From Baseline in Forced Vital Capacity (Week 8, Pre-dose) [ Time Frame: baseline, week 8, pre-dose ] [ Designated as safety issue: No ]
    Change from baseline in forced vital capacity (week 8, pre-dose)

  • Change From Baseline in Forced Vital Capacity (Week 8, 30 Minutes) [ Time Frame: baseline, week 8, 30 minutes ] [ Designated as safety issue: No ]
    Change from baseline in forced vital capacity (week 8, 30 minutes)

  • Change From Baseline in Forced Vital Capacity (Week 8, 60 Minutes) [ Time Frame: baseline, week 8, 60 minutes ] [ Designated as safety issue: No ]
    Change from baseline in forced vital capacity (week 8, 60 minutes)

  • Change From Baseline in Forced Vital Capacity (Week 8, 120 Minutes) [ Time Frame: baseline, week 8, 120 minutes ] [ Designated as safety issue: No ]
    Change from baseline in forced vital capacity (week 8, 120 minutes)

  • Change From Baseline in Forced Vital Capacity (Week 8, 180 Minutes) [ Time Frame: baseline, week 8, 180 minutes ] [ Designated as safety issue: No ]
    Change from baseline in forced vital capacity (week 8, 180 minutes)

  • Change From Baseline in Forced Vital Capacity (Week 16, Pre-dose) [ Time Frame: baseline, week 16, pre-dose ] [ Designated as safety issue: No ]
    Change from baseline in forced vital capacity (week 16, pre-dose)

  • Change From Baseline in Forced Vital Capacity (Week 16, 30 Minutes) [ Time Frame: baseline, week 16, 30 minutes ] [ Designated as safety issue: No ]
    Change from baseline in forced vital capacity (week 16, 30 minutes)

  • Change From Baseline in Forced Vital Capacity (Week 16, 60 Minutes) [ Time Frame: baseline, week 16, 60 minutes ] [ Designated as safety issue: No ]
    Change from baseline in forced vital capacity (week 16, 60 minutes)

  • Change From Baseline in Forced Vital Capacity (Week 16, 120 Minutes) [ Time Frame: baseline, week 16, 120 minutes ] [ Designated as safety issue: No ]
    Change from baseline in forced vital capacity (week 16, 120 minutes)

  • Change From Baseline in Forced Vital Capacity (Week 16, 180 Minutes) [ Time Frame: baseline, week 16, 180 minutes ] [ Designated as safety issue: No ]
    Change from baseline in forced vital capacity (week 16, 180 minutes)

  • Change From Baseline in Forced Vital Capacity (Week 24, Pre-dose) [ Time Frame: baseline, week 24, pre-dose ] [ Designated as safety issue: No ]
    Change from baseline in forced vital capacity (week 24, pre-dose)

  • Change From Baseline in Forced Vital Capacity (Week 24, 30 Minutes) [ Time Frame: baseline, week 24, 30 minutes ] [ Designated as safety issue: No ]
    Change from baseline in forced vital capacity (week 24, 30 minutes)

  • Change From Baseline in Forced Vital Capacity (Week 24, 60 Minutes) [ Time Frame: baseline, week 24, 60 minutes ] [ Designated as safety issue: No ]
    Change from baseline in forced vital capacity (week 24, 60 minutes)

  • Change From Baseline in Forced Vital Capacity (Week 24, 120 Minutes) [ Time Frame: baseline, week 24, 120 minutes ] [ Designated as safety issue: No ]
    Change from baseline in forced vital capacity (week 24, 120 minutes)

  • Change From Baseline in Forced Vital Capacity (Week 24, 180 Minutes) [ Time Frame: baseline, week 24, 180 minutes ] [ Designated as safety issue: No ]
    Change from baseline in forced vital capacity (week 24, 180 minutes)

  • Albuterol Use p.r.n. (Baseline) [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Number of days that participants used albuterol prn per week

  • Change From Baseline in Albuterol Use p.r.n. - (Week 4) [ Time Frame: baseline, week 4 ] [ Designated as safety issue: No ]
    Difference in number of days that participants used albuterol prn per week between week 4 and baseline

  • Change From Baseline in Albuterol Use p.r.n. - (Week 8) [ Time Frame: baseline, week 8 ] [ Designated as safety issue: No ]
    Difference in number of days that participants used albuterol prn per week between week 8 and baseline

  • Change From Baseline in Albuterol Use p.r.n. -(Week 12) [ Time Frame: baseline, week 12 ] [ Designated as safety issue: No ]
    Difference in number of days that participants used albuterol prn per week between week 12 and baseline

  • Change From Baseline in Albuterol Use p.r.n. - (Week 16) [ Time Frame: baseline, week 16 ] [ Designated as safety issue: No ]
    Difference in number of days that participants used albuterol prn per week between week 16 and baseline

  • Change From Baseline in Albuterol Use p.r.n. -(Week 20) [ Time Frame: baseline, week 20 ] [ Designated as safety issue: No ]
    Difference in number of days that participants used albuterol prn per week between week 20 and baseline

  • Change From Baseline in Albuterol Use p.r.n. - (Week 24) [ Time Frame: baseline, week 24 ] [ Designated as safety issue: No ]
    Difference in number of days that participants used albuterol prn per week between week 24 and baseline

  • Number of Participants With Categorical Scores on Physician's Global Assessment (Baseline) [ Time Frame: baseline ] [ Designated as safety issue: No ]

    The physician's global assessment reflected the physician's opinion of the participant's overall clinical condition with respect to COPD. The evaluation was based on the participant's use of concomitant medications, as well as the number and severity of COPD exacerbations and related emergency room visits and/or hospitalizations since the last visit. The frequency and severity of symptoms ( cough, dyspnea, wheezing) and the impact of these on the participant's ability to exercise were considered.

    Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.


  • Number of Participants With Categorical Scores on Physician's Global Assessment (Week 12) [ Time Frame: week 12 ] [ Designated as safety issue: No ]

    The physician's global assessment reflected the physician's opinion of the participant's overall clinical condition with respect to COPD. The evaluation was based on the participant's use of concomitant medications, as well as the number and severity of COPD exacerbations and related emergency room visits and/or hospitalizations since the last visit. The frequency and severity of symptoms ( cough, dyspnea, wheezing) and the impact of these on the participant's ability to exercise were considered.

    Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.


  • Number of Participants With Categorical Scores on Physician's Global Assessment (Week 24) [ Time Frame: week 24 ] [ Designated as safety issue: No ]

    The physician's global assessment reflected the physician's opinion of the participant's overall clinical condition with respect to COPD. The evaluation was based on the participant's use of concomitant medications, as well as the number and severity of COPD exacerbations and related emergency room visits and/or hospitalizations since the last visit. The frequency and severity of symptoms ( cough, dyspnea, wheezing) and the impact of these on the participant's ability to exercise were considered.

    Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.


  • Number of Participants With Categorical Scores on Patient's Global Assessment (Baseline) [ Time Frame: baseline ] [ Designated as safety issue: No ]

    The patient's global assessment was based on the subject's need to take additional medications for breathing, their need for emergency room or hospital visits for COPD, and severity and amount of coughing, wheezing, and/or breathing discomfort experienced, and the impact of these symptoms on the subject's ability to exercise and perform daily activities.

    Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.


  • Number of Participants With Categorical Scores on Patient's Global Assessment (Week 12) [ Time Frame: week 12 ] [ Designated as safety issue: No ]

    The patient's global assessment was based on the subject's need to take additional medications for breathing, their need for emergency room or hospital visits for COPD, and severity and amount of coughing, wheezing, and/or breathing discomfort experienced, and the impact of these symptoms on the subject's ability to exercise and perform daily activities.

    Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.


  • Number of Participants With Categorical Scores on Patient's Global Assessment (Week 24) [ Time Frame: week 24 ] [ Designated as safety issue: No ]

    The patient's global assessment was based on the subject's need to take additional medications for breathing, their need for emergency room or hospital visits for COPD, and severity and amount of coughing, wheezing, and/or breathing discomfort experienced, and the impact of these symptoms on the subject's ability to exercise and perform daily activities.

    Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.


  • Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Baseline) [ Time Frame: baseline ] [ Designated as safety issue: No ]

    WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment.

    Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment.


  • Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 4) [ Time Frame: baseline, week 4 ] [ Designated as safety issue: No ]
    WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline.

  • Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 8) [ Time Frame: baseline, week 8 ] [ Designated as safety issue: No ]
    WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline.

  • Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 12) [ Time Frame: baseline, week 12 ] [ Designated as safety issue: No ]
    WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline.

  • Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 16) [ Time Frame: baseline, week 16 ] [ Designated as safety issue: No ]
    WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline.

  • Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 20) [ Time Frame: baseline, week 20 ] [ Designated as safety issue: No ]
    WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline.

  • Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 24) [ Time Frame: baseline, week 24 ] [ Designated as safety issue: No ]
    WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline.

  • Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health [ Time Frame: baseline ] [ Designated as safety issue: No ]

    WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment.

    Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment.


  • Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 4) [ Time Frame: baseline, week 4 ] [ Designated as safety issue: No ]
    WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline.

  • Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 8) [ Time Frame: baseline, week 8 ] [ Designated as safety issue: No ]
    WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline.

  • Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 12) [ Time Frame: baseline, week 12 ] [ Designated as safety issue: No ]
    WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline.

  • Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 16) [ Time Frame: baseline, week 16 ] [ Designated as safety issue: No ]
    WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline.

  • Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 20) [ Time Frame: baseline, week 20 ] [ Designated as safety issue: No ]
    WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline.

  • Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 24) [ Time Frame: baseline, week 24 ] [ Designated as safety issue: No ]
    WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline.

  • Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Baseline) [ Time Frame: baseline ] [ Designated as safety issue: No ]

    WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment.

    Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment.


  • Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 4) [ Time Frame: baseline, week 4 ] [ Designated as safety issue: No ]
    WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline.

  • Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 8) [ Time Frame: baseline, week 8 ] [ Designated as safety issue: No ]
    WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline.

  • Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 12) [ Time Frame: baseline, week 12 ] [ Designated as safety issue: No ]
    WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline.

  • Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 16) [ Time Frame: baseline, week 16 ] [ Designated as safety issue: No ]
    WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline.

  • Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 20) [ Time Frame: baseline, week 20 ] [ Designated as safety issue: No ]
    WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline.

  • Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 24) [ Time Frame: baseline, week 24 ] [ Designated as safety issue: No ]
    WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline.

  • Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Baseline) [ Time Frame: baseline ] [ Designated as safety issue: No ]

    WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment.

    Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment.


  • Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 4) [ Time Frame: baseline, week 4 ] [ Designated as safety issue: No ]
    WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline.

  • Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 8) [ Time Frame: baseline, week 8 ] [ Designated as safety issue: No ]
    WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline.

  • Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 12) [ Time Frame: baseline, week 12 ] [ Designated as safety issue: No ]
    WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline.

  • Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 16) [ Time Frame: baseline, week 16 ] [ Designated as safety issue: No ]
    WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline.

  • Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 20) [ Time Frame: baseline, week 20 ] [ Designated as safety issue: No ]
    WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline.

  • Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 24) [ Time Frame: baseline, week 24 ] [ Designated as safety issue: No ]
    WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline.

  • Physical Activity (Light Intensity; Baseline) in Logarithm of Average Time Spent in Minutes Per Day [ Time Frame: baseline ] [ Designated as safety issue: No ]

    Light intensity is less than three metabolic equivalents.

    Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.

    ln in measure value unit means natural logarithm.


  • Change From Baseline in Physical Activity (Light Intensity; Week 4) in Logarithm of Average Time Spent in Minutes Per Day [ Time Frame: baseline, week 4 ] [ Designated as safety issue: No ]

    Light intensity is less than three metabolic equivalents

    Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.

    ln in measure value unit means natural logarithm


  • Change From Baseline in Physical Activity (Light Intensity; Week 8) in Logarithm of Average Time Spent in Minutes Per Day [ Time Frame: baseline, week 8 ] [ Designated as safety issue: No ]

    Light intensity is less than three metabolic equivalents

    Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.

    ln in measure value unit means natural logarithm


  • Change From Baseline in Physical Activity (Light Intensity; Week 12) in Logarithm of Average Time Spent in Minutes Per Day [ Time Frame: baseline, week 12 ] [ Designated as safety issue: No ]

    Light intensity defined as less than three metabolic equivalents.

    Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.

    ln in measure value unit means natural logarithm


  • Change From Baseline in Physical Activity (Light Intensity; Week 16) in Logarithm of Average Time Spent in Minutes Per Day [ Time Frame: baseline, week 16 ] [ Designated as safety issue: No ]

    Light intensity is less than three metabolic equivalents

    Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.

    ln in measure value unit means natural logarithm


  • Change From Baseline in Physical Activity (Light Intensity; Week 20) in Logarithm of Average Time Spent in Minutes Per Day [ Time Frame: baseline, week 20 ] [ Designated as safety issue: No ]

    Light intensity is less than three metabolic equivalents

    Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.

    ln in measure value unit means natural logarithm


  • Change From Baseline in Physical Activity (Light Intensity; Week 24) in Logarithm of Average Time Spent in Minutes Per Day [ Time Frame: baseline, week 24 ] [ Designated as safety issue: No ]

    Light intensity is less than three metabolic equivalents

    Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.

    ln in measure value unit means natural logarithm


  • Physical Activity (Moderate or Higher Intensity; Baseline) in Logarithm of Average Time Spent in Minutes Per Day [ Time Frame: baseline ] [ Designated as safety issue: No ]

    Moderate or higher intensity is greater than or equal to three metabolic equivalents

    Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.

    ln in measure value unit means natural logarithm


  • Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 4) in Logarithm of Average Time Spent in Minutes Per Day [ Time Frame: baseline, week 4 ] [ Designated as safety issue: No ]

    Moderate or higher intensity is greater than or equal to three metabolic equivalents

    Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.

    ln in measure value unit means natural logarithm


  • Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 8) in Logarithm of Average Time Spent in Minutes Per Day [ Time Frame: baseline, week 8 ] [ Designated as safety issue: No ]

    Moderate or higher intensity is greater than or equal to three metabolic equivalents

    Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.

    ln in measure value unit means natural logarithm


  • Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 12) in Logarithm of Average Time Spent in Minutes Per Day [ Time Frame: baseline, week 12 ] [ Designated as safety issue: No ]

    Moderate or higher intensity is greater than or equal to three metabolic equivalents

    Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.

    ln in measure value unit means natural logarithm


  • Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 16) in Logarithm of Average Time Spent in Minutes Per Day [ Time Frame: baseline, week 16 ] [ Designated as safety issue: No ]

    Moderate or higher intensity is greater than or equal to three metabolic equivalents

    Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.

    ln in measure value unit means natural logarithm


  • Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 20) in Logarithm of Average Time Spent in Minutes Per Day [ Time Frame: baseline, week 20 ] [ Designated as safety issue: No ]

    Moderate or higher intensity is greater than or equal to three metabolic equivalents

    Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.

    ln in measure value unit means natural logarithm


  • Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 24) in Logarithm of Average Time Spent in Minutes Per Day [ Time Frame: baseline, week 24 ] [ Designated as safety issue: No ]

    Moderate or higher intensity is greater than or equal to three metabolic equivalents

    Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.

    ln in measure value unit means natural logarithm


  • Number of Participants With Healthy Lifestyle (Baseline) [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no

  • Number of Participants With Healthy Lifestyle (Week 4) [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no

  • Number of Participants With Healthy Lifestyle (Week 8) [ Time Frame: week 8 ] [ Designated as safety issue: No ]
    Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no

  • Number of Participants With Healthy Lifestyle (Week 12) [ Time Frame: week 12 ] [ Designated as safety issue: No ]
    Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no

  • Number of Participants With Healthy Lifestyle (Week 16) [ Time Frame: week 16 ] [ Designated as safety issue: No ]
    Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no

  • Number of Participants With Healthy Lifestyle (Week 20) [ Time Frame: week 20 ] [ Designated as safety issue: No ]
    Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no

  • Number of Participants With Healthy Lifestyle (Week 24) [ Time Frame: week 24 ] [ Designated as safety issue: No ]
    Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no

  • Active Energy Expenditure (Baseline) [ Time Frame: baseline ] [ Designated as safety issue: No ]
    The amount of energy (kcal/day) that a person uses while physically active.

  • Change From Baseline in Active Energy Expenditure (Week 4) [ Time Frame: baseline, week 4 ] [ Designated as safety issue: No ]
    The amount of energy (kcal/day) that a person uses while physically active.

  • Change From Baseline in Active Energy Expenditure (Week 8) [ Time Frame: baseline, week 8 ] [ Designated as safety issue: No ]
    The amount of energy (kcal/day) that a person uses while physically active.

  • Change From Baseline in Active Energy Expenditure (Week 12) [ Time Frame: baseline, week 12 ] [ Designated as safety issue: No ]
    The amount of energy (kcal/day) that a person uses while physically active.

  • Change From Baseline in Active Energy Expenditure (Week 16) [ Time Frame: baseline, week 16 ] [ Designated as safety issue: No ]
    The amount of energy (kcal/day) that a person uses while physically active.

  • Change From Baseline in Active Energy Expenditure (Week 20) [ Time Frame: baseline, week 20 ] [ Designated as safety issue: No ]
    The amount of energy (kcal/day) that a person uses while physically active.

  • Change From Baseline in Active Energy Expenditure (Week 24) [ Time Frame: baseline, week 24 ] [ Designated as safety issue: No ]
    The amount of energy (kcal/day) that a person uses while physically active.

  • Number of Steps Per Day (Baseline) [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Number of steps per day (baseline)

  • Change From Baseline in Number of Steps Per Day (Week 4) [ Time Frame: baseline, week 4 ] [ Designated as safety issue: No ]
    Change from baseline in number of steps per day (week 4)

  • Change From Baseline in Number of Steps Per Day(Week 8) [ Time Frame: baseline, week 8 ] [ Designated as safety issue: No ]
    Change from baseline in number of steps per day (week 8)

  • Change From Baseline in Number of Steps Per Day (Week 12) [ Time Frame: baseline, week 12 ] [ Designated as safety issue: No ]
    Change from baseline in Number of steps per day (week 12)

  • Change From Baseline in Number of Steps Per Day (Week 16) [ Time Frame: baseline, week 16 ] [ Designated as safety issue: No ]
    Change from baseline in number of steps per day (week 16)

  • Change From Baseline in Number of Steps Per Day (Week 20) [ Time Frame: baseline, week 20 ] [ Designated as safety issue: No ]
    Change from baseline in number of steps per day (week 20)

  • Change From Baseline in Number of Steps Per Day (Week 24) [ Time Frame: baseline, week 24 ] [ Designated as safety issue: No ]
    Change from baseline in number of steps per day (week 24)


Enrollment: 457
Study Start Date: April 2007
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo
Oral inhalation once daily of placebo matching tiotropium via handihaler
Drug: Placebo
Oral inhalation once daily of placebo matching tiotropium via handihaler
Experimental: tiotropium
Oral inhalation once daily of 18mcg tiotropium via handihaler
Drug: tiotropium
Oral inhalation once daily of 18mcg tiotropium via handihaler

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

All subjects must have a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) according to Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) guideline criteria:

post-bronchodilator Forced Expiratory Volume in one Second/Forced Vital Capacity (FEV1/FVC) ratio < 70% (visit 1).

Subjects must be GOLD Stage II and have a post-bronchodilator FEV1 >50% and < 80% of predicted normal (visit 1). Subjects must be current or ex-smokers with a smoking history of >=10 pack years.

Subjects must have a Medical Research Council (MRC) dyspnea score >= 2.

Exclusion criteria:

Subjects who have been treated with maintenance medications for chronic respiratory disease within six months prior to screening.

Subjects with significant diseases other than COPD. Subjects on chronic systemic corticosteroids.

Subjects with any upper and/or lower respiratory tract infection or COPD exacerbation in the 6 weeks prior to the initial visit 1 or during the screening period prior to visit 3 Subjects with a recent (past 6 months) myocardial infarction, any unstable or life threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year; or who have been hospitalized for cardiac failure during the past year.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00523991

  Show 62 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Pfizer
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00523991     History of Changes
Obsolete Identifiers: NCT00460772
Other Study ID Numbers: 205.365, A4471008, 2006-006276-38
Study First Received: July 9, 2007
Results First Received: July 1, 2011
Last Updated: May 12, 2014
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
Canada: Health Canada - Therapeutic Products Directorate
Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10
Germany: Federal Institute for Drugs and Medical Devices
Great Britain: MHRA
Greece: National Organization of Medicines (EOF)
Netherlands: Central Committee on Research involving Human Subjects (CCMO)
Portugal: National Pharmacy and Medicines Institute
Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine)
United States: Food and Drug Administration

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Tiotropium
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 01, 2014