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Trial record 27 of 82606 for:    measured

A Randomised, Double-blind, Placebo-controlled, 12 Week Trial to Evaluate the Effect of Tiotropium Inhalation Capsules (Spiriva) on the Magnitude of Exercise, Measured Using an Accelerometer, in Patients With Chronic Obstructive Pulmonary Disease (COPD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00144326
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : November 1, 2013
Sponsor:
Information provided by:
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE September 2, 2005
First Posted Date  ICMJE September 5, 2005
Last Update Posted Date November 1, 2013
Study Start Date  ICMJE July 2003
Actual Primary Completion Date October 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 2, 2005)
Primary endpoint: The primary efficacy variable will be the difference in physical activity measured in vector magnitude units (VMUs) by the triaxial Stayhealthy RT3 accelerometer at the end of the three month treatment period compared to placebo.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00144326 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 26, 2008)
Pulmonary function tests, distance covered in the 6MWD, Modified Borg Dyspnea scale, QoL measured by the CRQ, use of rescue salbutamol, and safety variables.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2005)
Pulmonary Function Tests, Distance covered in the 6MWD, Modified Borg Dyspnea scale, QoL mesured by the CRQ, use of rescue salbutamol, and safety variables
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomised, Double-blind, Placebo-controlled, 12 Week Trial to Evaluate the Effect of Tiotropium Inhalation Capsules (Spiriva) on the Magnitude of Exercise, Measured Using an Accelerometer, in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official Title  ICMJE A Randomised, Double-blind, Placebo-controlled, 12 Week Trial to Evaluate the Effect, of Tiotropium Inhalation Capsules on the Magnitude of Exercise, Measured Using an Accelerometer, in Patients With Chronic Obstructive Pulmonary Disease (COPD).
Brief Summary The objective of this study is to determine if tiotropium (Spiriva, Bromuro de Tiotropio) 18 mcg once daily by oral inhalation compared to placebo increases the magnitude of daily physical activity observed in COPD patients, measured using an accelerometer.
Detailed Description

This is a 3 month, multicentre, randomised, double-blind, placebo controlled, parallel group study to compare with placebo the long-term effect of tiotropium inhalation capsules on daily physical activity in patients with COPD.

The drugs will be administered in the form of inhalation capsules of tiotropium or placebo, taken once daily in the morning.

The record of daily physical activity using the accelerometer will be carried out at all study visits other than Visit 1. The accelerometer will be used for the five day period, from Thursday to Monday, closest to the corresponding visit.

The pulmonary function tests will be carried out at Visit 1 (screening visit), Visit 2 (baseline visit) and study visits (Visits 3 to 5) with the restrictions detailed at the trial protocol.

Study Hypothesis:

The null hypothesis is that there is no difference between tiotropium (Spiriva) and placebo regarding the magnitude of exercise measured with an accelerometer. The alternative hypothesis is that there is a difference between tiotropium (Spiriva) and placebo regarding the magnitude of exercise measured with an accelerometer.

Comparison(s):

The difference in physical activity measured in vector magnitude units (VMUs) by the triaxial Stayhealthy RT3 accelerometer at the end of the three month treatment period compared to placebo.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Pulmonary Disease, Chronic Obstructive
Intervention  ICMJE
  • Drug: Tiotropium Bromide
  • Drug: Placebo
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 31, 2013)
250
Original Enrollment  ICMJE
 (submitted: September 2, 2005)
258
Study Completion Date  ICMJE October 2005
Actual Primary Completion Date October 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All patients must sign an Informed Consent Form consistent with ICH-GPC guidelines prior to participation in the trial
  • Diagnosis of COPD and meets the following spirometric criteria:

    • The patients must present with relatively stable* airway obstruction
    • An FEV1 <= 65% of the predicted normal value and an FEV1 <= 70% of the FVC, at visit 1 (screening). This must be confirmed at visit 2 (baseline).
  • Male or female patients of 40 years of age or older.
  • The patients must be smokers or ex-smokers with a history of having smoked at least 10 pack-years.
  • The patients must be able to carry out all the tests related to the study, including the slow and forced spirometry and the 6 minute walk test, exactly as required in the protocol.
  • The patients must be able to inhale the medication by means of the HandiHaler.

Exclusion Criteria:

  • Those patients with significant diseases other than COPD will be excluded.
  • Patients who regularly use daytime oxygen therapy for more than 1 hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy during the study.
  • Patients with any respiratory tract infection in the past six weeks prior to the screening visit (Visit 1) or during the run-in period, prior to Visit 2 (baseline).
  • Patients with a past history of asthma, allergic rhinitis or atopy, or who present a total eosinophil count >= 600 mm3. No new eosinophil count will be undertaken in these patients.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Germany,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00144326
Other Study ID Numbers  ICMJE 205.269
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Study Coordinator B.I. Spain S.A.
PRS Account Boehringer Ingelheim
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP