- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02172300
Effect of Tiotropium on Exercise Tolerance in Patients With Chronic Obstructive Pulmonary Disease (COPD)
June 20, 2014 updated by: Boehringer Ingelheim
Effect of Tiotropium on Exercise Tolerance and Static and Dynamic Lung Volumes in COPD Patients (A Randomized Double-Blind, Placebo Controlled, Parallel Group Study)
Study to investigate whether tiotropium therapy can increase duration of steady-state exercise by decreasing dynamic and static lung hyperinflation in COPD patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
198
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
All patients had to have a diagnosis of COPD. Patients had to meet the following spirometric and static lung volume criteria:
- Patients had to have relatively stable, mild (stage I according to the criteria of the American Thoracic Society (ATS); original trial protocol: moderate) to severe airway obstruction with an FEV1 less than or equal to 65% of predicted values. All patients had to have presence of lung hyperinflation as demonstrated by thoracic gas volume (TGV) / functional residual capacity (FRC) greater than or equal to 120% of predicted value as determined by body plethysmography at Visit 1 (day -15).
- Male or female patients ≥ 40 but ≤ 70 years old.
- Patients had to have a cigarette smoking history of more than 10 pack-years. A pack-year was defined as the equivalent of smoking one pack of cigarettes per day for a year.
- Patients had to be able to perform all specified procedures and maintain records during the study period as required in the protocol.
- Patients had to be able to inhale medication from the HandiHaler®.
- All patients had to sign an Informed Consent Form in accordance with Good Clinical Practice (GCP) and local legislative requirements prior to participation in the trial . i.e., prior to pre-study washout of their usual pulmonary medications.
Exclusion Criteria:
- Patients with significant diseases other than COPD were to be excluded. A significant disease was defined either as a disease, which in the opinion of the investigator might have put the patient at risk because of participation in the study or a disease, which might have influenced the results of the study or the patient's ability to participate in the study.
- Patients with clinically significant abnormal baseline hematology, blood chemistry or urinalysis. If the abnormality defined a disease listed as an exclusion criterion, the patient was to be excluded.
- All patients with a serum glutamic oxaloacetic transaminase (SGOT or AST) ≥ 1.5 of the upper limit of normal range (x ULN), serum glutamic pyruvic transaminase (SGPT or ALT) ≥ 1.5 x ULN, bilirubin ≥ 1.5 x ULN, or creatinine ≥ 1.5 x ULN were excluded regardless of the clinical condition. Repeat laboratory evaluation was not to be conducted in these subjects.
- Patients with a recent history (i.e., 1 year or less) of myocardial infarction.
- Patients with a recent history (i.e., 3 years or less) of heart failure, pulmonary edema, or patients with cardiac arrhythmia (with or without symptoms) or any contraindication to exercise as indicated in Protocol Appendix four (see Section 9.5.1 and Appendices 16.1.1.1 and 16.1.1.2).
- Patients with regular use of daytime oxygen therapy. (In centers with significantly decreased barometric pressure, exercise tests can be done with inhaled oxygen).
- Patients with known active tuberculosis.
- Patients with a history of cancer within the last 5 years. Patients with treated basal cell carcinoma were allowed.
- Patients with a history of life-threatening pulmonary obstruction or a history of cystic fibrosis or bronchiectasis.
- Patients who had undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reason were to be evaluated as per exclusion criterion No. 1.
- Patients with upper respiratory tract infection in the past 6 weeks prior to the Screening visit (Visit 1, day -15) or during the run-in period.
- Patients with known hypersensitivity to anticholinergic drugs, lactose or any other components of the inhalation capsule delivery system.
- Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction.
- Patients with known narrow-angle glaucoma.
- Patients with a history of asthma, allergic rhinitis or atopy or who have a total blood eosinophil count ≥ 600/mm3. A repeat eosinophil count was not to be conducted in these patients.
- Patients who were being treated with cromolyn sodium or nedocromil sodium had to stop these medications 1 month before Visit 1 (day -15).
- Patients who were being treated with antihistamines (H1 receptor antagonists) or antileukotrienes had to stop these medications 1 month before Visit 1 (day -15).
- Patients using oral corticosteroid medication at unstable doses (i.e., less than 6 weeks on a stable dose) or at a dose in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day.
- Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e., oral contraceptives, intrauterine devices, diaphragm or Norplant®).
- Patients with history or active alcohol or drug abuse.
- Patients who had taken an investigational drug within 1 month or 10 half lives (whichever was greater) prior to Screening visit (Visit 1, day -15).
- Limitation of exercise performance as a result of factors other than fatigue or exertional dyspnea such as arthritis in the leg, angina or claudication.
- Patients who participated in any rehabilitation program for COPD within 6 weeks prior to Visit 1 (day -15).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tiotropium
Tiotropium inhalation capsules via HandiHaler
|
|
Placebo Comparator: Placebo
Placebo inhalation capsules via HandiHaler
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluation of submaximal exercise tolerance (as measured by endurance time during a constant work rate exercise test to symptom limitation)
Time Frame: Day 42
|
Day 42
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Endurance time after first dosing
Time Frame: Day 0 and 21
|
Day 0 and 21
|
Determination of breathlessness (dyspnea) during constant work rate exercise test as measured by the modified Borg Scale
Time Frame: Day -10, -5, 0, 21 and 42
|
Day -10, -5, 0, 21 and 42
|
Determination of leg discomfort during constant work rate exercise test as measured by the modified Borg Scale
Time Frame: Day -10, -5, 0, 21 and 42
|
Day -10, -5, 0, 21 and 42
|
Evaluation of dynamic lung hyperinflation during exercise
Time Frame: Day -10, -5, 0, 21 and 42
|
Day -10, -5, 0, 21 and 42
|
Evaluation of dynamic hyperinflation (DH) as negative change in inspiratory capacity (IC) from rest
Time Frame: Day -10, -5, 0, 21 and 42
|
Day -10, -5, 0, 21 and 42
|
Evaluation of static lung hyperinflation
Time Frame: Day -10, -5, 0, 21 and 42
|
Day -10, -5, 0, 21 and 42
|
Evaluation of TAV (Trapped air volume) at rest
Time Frame: Day -10, -5, 0, 21 and 42
|
Day -10, -5, 0, 21 and 42
|
Evaluation of slow vital capacity (SVC)
Time Frame: Day -10, -5, 0, 21, 42 and 56
|
Day -10, -5, 0, 21, 42 and 56
|
Evaluation of FEV1 (Forced expiratory volume in one second)
Time Frame: Day -10, -5, 0, 21 and 42
|
Day -10, -5, 0, 21 and 42
|
Evaluation of forced vital capacity (FVC)
Time Frame: Day -10, -5, 0, 21 and 42
|
Day -10, -5, 0, 21 and 42
|
Evaluation of forced expiratory flow rate between 25% and 75% of FVC which has been exhaled (FEF25-75%)
Time Frame: Day -10, -5, 0, 21 and 42
|
Day -10, -5, 0, 21 and 42
|
Evaluation of forced expiratory flow rate at 50% of FVC which has been exhaled (FEF50%)
Time Frame: Day -10, -5, 0, 21 and 42
|
Day -10, -5, 0, 21 and 42
|
Evaluation of forced expiratory flow rate at 75% of FVC which has been exhaled (FEF75%)
Time Frame: Day -10, -5, 0, 21 and 42
|
Day -10, -5, 0, 21 and 42
|
Evaluation of total lung capacity (TLC), airway resistance (Raw), and specific airway conductance (SGaw)
Time Frame: Day -10, -5, 0, 21 and 42
|
Day -10, -5, 0, 21 and 42
|
Evaluation of dyspnea using the Baseline Dyspnea Index (BDI) and Transition Dyspnoea Index (TDI)
Time Frame: Day 0, 21 and 42
|
Day 0, 21 and 42
|
Determination of arterial oxygen saturation (SaO2), oxygen consumption (VO2), tidal volume (VT), breathing frequency (F), and minute ventilation (VE)
Time Frame: Day -10, -5, 0, 21 and 42
|
Day -10, -5, 0, 21 and 42
|
Physicians Global Assessment
Time Frame: Day 0 and 42
|
Day 0 and 42
|
Evaluation of COPD symptom scores
Time Frame: Day 0, 21 and 42
|
Day 0, 21 and 42
|
Reason for stopping constant work rate exercise
Time Frame: Day -15, -10, -5, 0, 21 and 42
|
Day -15, -10, -5, 0, 21 and 42
|
Rescue medication use during test days
Time Frame: Day -15, -10, -5, 0, 21 and 42
|
Day -15, -10, -5, 0, 21 and 42
|
Rescue medication use as weekly mean for number of night-time puffs (Rescni,w), daytime puffs (Rescday,w) and total daily puffs (Resctot,w) of rescue medication
Time Frame: until week 6
|
until week 6
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 1999
Primary Completion (Actual)
November 1, 2000
Study Registration Dates
First Submitted
June 20, 2014
First Submitted That Met QC Criteria
June 20, 2014
First Posted (Estimate)
June 24, 2014
Study Record Updates
Last Update Posted (Estimate)
June 24, 2014
Last Update Submitted That Met QC Criteria
June 20, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Lung Diseases, Obstructive
- Lung Diseases
- Pulmonary Disease, Chronic Obstructive
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Parasympatholytics
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Antagonists
- Cholinergic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Tiotropium Bromide
Other Study ID Numbers
- 205.131
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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