Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
Evaluate whether the effect of inhaled tiotropium bromide on the change in trough forced expiratory volume (FEV1), compared to placebo in patients with chronic obstructive pulmonary disease (COPD), is affected by smoking status.
Detailed description
Evaluate whether the effect of inhaled tiotropium bromide on the change in trough FEV1 from baseline to week 12 compared to placebo in patients with COPD is affected by smoking status. Secondary objectives include FEV1 at interim visit and FVC at on-treatment visits, use of rescue medication, COPD symptom scores, Physicians Global Evaluation and EQ-5D scores. Study Hypothesis: The primary objective of the study is to show superiority of tiotropium against placebo with respect to trough FEV1 at 12 weeks. Then the 5% two-sided hypotheses test is: H0: Mean trough FEV1 at 12 weeks in tiotropium = Mean trough FEV1 at 12 weeks in placebo H1: Mean trough FEV1 at 12 weeks in tiotropium unequal Mean trough FEV1 at 12 weeks in placebo If the null hypothesis is rejected in favour of the alternative hypothesis (H1) based on all patients, the same hypotheses will be tested in both sub-populations of current and ex-smokers respectively. Comparison(s): Tiotropium bromide - 18 mcg capsule inhaled via the HandiHaler vs Placebo powder capsules for oral inhalation, via the HandiHaler.
Interventions
DRUGtiotropium bromide
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Main Inclusion criteria: 1.Diagnosis of chronic obstructive pulmonary disease. 2.Patient is male or female, age \<=than 40 years. 3. Patient has a smoking history of \<=10 pack-year.4.Patient is able to be trained in the proper use of HandiHaler 5.Patient is able to be trained to perform technically satisfactory spirometry and must be able to maintain records during the study period as required by the protocol. 6.Patient must be willing and able to sign informed consent prior to participation in the study i.e. prior to washout of their usual pulmonary medications. Main
Exclusion criteria
1.History of asthma, allergic rhinitis or atopy. 2. A lower respiratory tract infection or any COPD exacerbation in the past 4 weeks prior to Visit 1 or during the two week Screening Period 3.History of life threatening bronchial obstruction, cystic fibrosis or bronchiectasis 4. Oral corticosteroid medication if initiated or modified within the last 6 weeks prior to Visit 1 or if daily dose \> 10 mg prednisone or 20 mg or more every other day (or equivalent). 5.Patients who have started or stopped an exercise rehabilitation program within 4 weeks of visit 6.Patients who regularly use daytime oxygen therapy for more than one hour per day and who, in the investigator's opinion, will be unable to abstain from the use of oxygen therapy during testing. 7. Patients who have undergone thoracotomy with pulmonary resection or lobectomy (lung volume reduction surgery). 8.Tuberculosis with indication for treatment. 9. Recent history (i.e. 6 months or less) of myocardial infarction.10. Patients with known moderate or severe renal insufficiency.11. Patients with symptomatic prostatic hypertrophy or bladder neck obstruction. 12.Patients with known narrow-angle glaucoma.13.History of unstable arrhythmia with a life threatening event or change of therapy during the past year.14. History of cancer, other than treated basal cell carcinoma, within the last 5 years 15.Intolerance to anticholinergic containing products, and/or to lactose or any other components of the inhalation capsule delivery system.16.Patients who are being treated with beta-blockers including eye drops.17.Patients who are being treated with antihistamines (H1 receptor antagonists), for asthma or excluded allergic conditions (See
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in trough FEV1 after 12 weeks of treatment. | week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Change in FVC at weeks 6 and 12 | week 6, week 12 |
| Use of rescue medication (daytime and night-time) | 12 weeks |
| Assessment of COPD symptoms | week 0, week 6, week 12 |
| Trough FEV1 at interim visit | week 6 |
| Quality of life questionnaire (EQ-5D) at Visits 2 and 4 | week 0, week 12 |
| Pulse Rate | 12 weeks |
| Blood Pressure | 12 weeks |
| The Physician's Global Evaluation at Visits 2 and 4 | week 0, week 12 |
Countries
Portugal
Outcome results
None listed