Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Tiotropium / Respimat One-Year Study

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: NCT00168844
Recruitment Status : Completed
First Posted : September 15, 2005
Results First Posted : October 7, 2009
Last Update Posted : May 20, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 15, 2005
Results First Submitted Date  ICMJE January 30, 2009
Results First Posted Date  ICMJE October 7, 2009
Last Update Posted Date May 20, 2014
Study Start Date  ICMJE January 2003
Actual Primary Completion Date June 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2013)
  • Change From Baseline in Trough FEV1 at Week 48, Full Analysis Set - Clinic Spirometry (FAS-PFT) [ Time Frame: 10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication ]
    Trough Forced Expiratory Volume in 1 second (FEV1)
  • Saint George's Respiratory Questionnaire (SGRQ) Total Score, Full Analysis Set - Saint George's Respiratory Questionnaire (FAS-QOL) [ Time Frame: Week 48 ]
    Rating scale of 3 domains - symptoms, activities and impact (weighted). Worst score = 100, best score = 0
  • TDI Focal Score, Full Analysis Set - Transitional Dyspnoea Index (FAS-TDI) (Combined Studies) [ Time Frame: Week 48 ]
    Rating scale of 3 components - change in functional impairment, change in magnitude of tasks, change in magnitude of efforts. Worst score = -9, best score = +9 For this endpoint data of twin studies NCT00168844 and NCT00168831 was combined.
  • COPD Exacerbation Rate, Safety Set (SS) (Combined Studies) [ Time Frame: 48 weeks ]
    Number of Chronic Obstructive Pulmonary Disease (COPD) exacerbations per patient year. For this endpoint data of the twin studies NCT00168844 and NCT00168831 was combined.
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
Change in FEV1 (bronchodilator efficacy); Change in SGRQ (quality of life); Change in Mahler TDI (effect on dyspnoea); change in frequency of exacerbations.
Change History Complete list of historical versions of study NCT00168844 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2013)
  • Change From Baseline in Heart Rate [ Time Frame: Baseline to Week 40 pre-dose ]
    Week 40 pre-dose - baseline
  • Change From Baseline in PR Interval [ Time Frame: Baseline to Week 40 pre-dose ]
  • Change From Baseline in QRS Interval [ Time Frame: Baseline to Week 40 pre-dose ]
    Week 40 pre-dose - baseline
  • Change From Baseline in QT Interval [ Time Frame: Baseline to Week 40 pre-dose ]
    Week 40 pre-dose - baseline
  • Change From Baseline in QT Interval (Bazett) [ Time Frame: Baseline to Week 40 pre-dose ]
    Week 40 pre-dose - baseline
  • Change From Baseline in QT Interval (Fridericia) [ Time Frame: Baseline to Week 40 pre-dose ]
    Week 40 pre-dose - baseline
  • Change From Baseline in Heart Rate [ Time Frame: Baseline to Week 40 ]
    Week 40 - baseline
  • Change From Baseline in Supraventricular Premature Beat (SVPB) Total [ Time Frame: Baseline to Week 40 ]
    Week 40 - baseline
  • Holter (24-hour Period) - SVPB (Supraventricular Premature Beat) Run Events Change From Baseline in Supraventricular Premature Beat (SVPB) Run Events [ Time Frame: Baseline to Week 40 ]
    Week 40 - baseline
  • Change From Baseline in SVPB Pairs [ Time Frame: Baseline to Week 40 ]
    Week 40 - baseline
  • Change From Baseline in Ventricular Premature Beat (VPB) Total [ Time Frame: Baseline to Week 40 ]
    Week 40 - baseline
  • Change From Baseline in VPB Run Events [ Time Frame: Baseline to Week 40 ]
    Week 40 - baseline
  • Change From Baseline in VPB Pairs [ Time Frame: Baseline to Week 40 ]
    Week 40 - baseline
  • Change From Baseline in Haematocrit, Packed Cell Volume (PCV) [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
    Volume of red cells (erythrocytes) in blood, expressed as a fraction (percentage) of the total volume of blood
  • Change From Baseline in Haemoglobin [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
    Week 48 - baseline
  • Change From Baseline in Red Blood Cell Count [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
    Week 48 - baseline
  • Change From Baseline in White Blood Cell Count [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
    Week 48 - baseline
  • Change From Baseline in Platelets [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
    Week 48 - baseline
  • Change From Baseline in Neutrophils [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
    Week 48 - baseline
  • Change From Baseline in Eosinophils [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
    Week 48 - baseline
  • Change From Baseline in Basophils [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
    Week 48 - baseline
  • Change From Baseline in Lymphocytes [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
    Week 48 - baseline
  • Change From Baseline in Monocytes [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
    Week 48 - baseline
  • Change From Baseline in Neutrophils (Absolute) [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
    Week 48 - baseline
  • Change From Baseline in Lymphocytes (Absolute) [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
    Week 48 - baseline
  • Change From Baseline in Eosinophils (Absolute) [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
    Week 48 - baseline
  • Change From Baseline in Basophils (Absolute) [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
    Week 48 - baseline
  • Change From Baseline in Monocytes (Absolute) [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
    Week 48 - baseline
  • Change From Baseline in Calcium [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
    Week 48 - baseline
  • Change From Baseline in Phosphate [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
    Week 48 - baseline
  • Change From Baseline in Aspartate Transaminase (AST)/Glutamic-Oxaloacetic Transaminase (GOT), Serum GOT (SGOT) [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
    Week 48 - baseline
  • Change From Baseline in Alanine Transaminase (ALT)/Glutamic Pyruvic Transaminase (GPT), Serum GPT (SGPT) [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
    Week 48 - baseline
  • Change From Baseline in Alkaline Phosphatase [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
    Week 48 - baseline
  • Change From Baseline in Lactic Dehydrogenase (LDH) [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
    Week 48 - baseline
  • Change From Baseline in Glucose [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
    Week 48 - baseline
  • Change From Baseline in Urea [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
    Week 48 - baseline
  • Change From Baseline in Blood Urea Nitrogen [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
    Week 48 - baseline
  • Change From Baseline in Creatinine [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
    Week 48 - baseline
  • Change From Baseline in Bilirubin, Total [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
    Week 48 - baseline
  • Change From Baseline in Uric Acid [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
    Week 48 - baseline
  • Change From Baseline in Protein, Total [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
    Week 48 - baseline
  • Change From Baseline in Albumin [ Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48 ]
    Week 48 - baseline
  • Change From Baseline in Trough FEV1 After 2, 8, 16, 24, 32 and 40 Weeks [ Time Frame: 10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication ]
    Change From Baseline in Trough Forced Expiratory Volume in 1 second (FEV1) after 2, 8, 16, 24, 32 and 40 weeks. The means are adjusted for centre, smoking status at entry and baseline value.
  • Change From Baseline in Trough FVC After 2, 8, 16, 24, 32, 40 and 48 Weeks [ Time Frame: 10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication ]
    Change From Baseline in Trough Forced vital capacity (FVC) after 2, 8, 16, 24, 32, 40 and 48 weeks. The means are adjusted for centre, smoking status at entry and baseline value.
  • Change From Baseline in FEV1 AUC0-3 After 2, 8, 16, 24, 32, 40 and 48 Weeks [ Time Frame: 10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication ]
    FEV1 AUC0-3 represents the Area under Curve over the time interval from 0 to 3 hours after 2, 8, 16, 24, 32, 40 and 48 weeks. The means are adjusted for centre, smoking status at entry and baseline value.
  • Change From Baseline in FVC AUC0-3 After 2, 8, 16, 24, 32, 40 and 48 Weeks [ Time Frame: 10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication ]
    FVC AUC0-3 represents the Area under Curve over the time interval from 0 to 3 hours after 2, 8, 16, 24, 32, 40 and 48 weeks. The means are adjusted for centre, smoking status at entry and baseline value.
  • Weekly Mean Morning Pre-dose PEFRs [ Time Frame: Weeks 2, 8, 16, 24, 32, 40, 48 ]
    Weekly mean morning pre-dose peak expiratory flow rates (PEFRs). The means are adjusted for centre, smoking status at entry, and baseline value.
  • Weekly Mean Evening PEFRs [ Time Frame: Weeks 2, 8, 16, 24, 32, 40, 48 ]
    Weekly mean evening peak expiratory flow rates (PEFRs). The means are adjusted for centre, smoking status at entry, and baseline value.
  • Weekly Mean Number of Puffs of Rescue Medication Per Day [ Time Frame: Weeks 2, 8, 16, 24, 32, 40, 48 ]
    Weekly mean number of puffs of rescue medication used per day as required (PRN salbutamol). The means are adjusted for centre, smoking status at entry, and baseline value.
  • Mahler TDI Scores [ Time Frame: Week 48 ]
    Mahler Transitional Dyspnoea Index (TDI) scores measured as change in functional impairment, change in magnitude of tasks and change in magnitude of efforts over the treatment period. The means are adjusted for centre, smoking status at entry and baseline value. Worst score = -3, best score = +3
  • Saint George's Respiratory Questionnaire (SGRQ) Scores [ Time Frame: Week 48 ]
    Saint George's Respiratory Questionnaire (SGRQ) Scores impacts, activities and symptoms. Worst score = 100, best score = 0. The means are adjusted for centre, smoking status at entry and baseline value.
  • COPD Symptoms Scores [ Time Frame: Week 48 ]
    COPD symptoms Scores - wheezing, shortness of breath, coughing and tightness of chest over the treatment period. Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe The means are adjusted for centre, smoking status at entry and baseline value.
  • PGE Scores [ Time Frame: Week 48 ]
    Physician's Global evaluation (PGE) scores over the treatment period. Scale: 1−2 = Poor, 3−4 = Fair, 5−6 = Good, 7−8 = Excellent The means are adjusted for centre, smoking status at entry and baseline value.
  • PGR Score [ Time Frame: Week 48 ]
    Patient's Global rating (PGR) score over the treatment period. Scale: 1=much better to 7=much worse The means are adjusted for centre, smoking status at entry and baseline value.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
Adverse event monitoring; Holter / ECG monitoring / clinical laboratory measurements (all safety outcomes)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tiotropium / Respimat One-Year Study
Official Title  ICMJE A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Comparison of One-Year Treatment of Two Doses (5mg and 10mg) of Tiotropium Inhalation Solution Delivered by the Respimat Device in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary To evaluate the long term effects of treatment with two doses of Tiotropium delivered by the Respimat inhaler in patients with COPD.
Detailed Description Not Provided
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 Inhalation Solution
  • Other: Placebo
Study Arms  ICMJE
  • Tiotropium Respimat 5mcg (Tio R5)
    Intervention: Drug: Tiotropium Inhalation Solution
  • Tiotropium Respimat 10mcg (Tio R10)
    Intervention: Drug: Tiotropium Inhalation Solution
  • Placebo
    Intervention: Other: Placebo
Publications *

*   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: September 4, 2009)
983
Original Enrollment  ICMJE
 (submitted: September 12, 2005)
960
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date June 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE Not Provided
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 Australia,   Belgium,   Canada,   France,   Germany,   Greece,   Netherlands,   Norway,   Russian Federation,   Spain,   Sweden,   Turkey,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00168844
Other Study ID Numbers  ICMJE 205.254
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 Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date September 2013

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