Chronic obstructive pulmonary disease (COPD) Respiratory Pulmonary disease
Conditions
Interventions
1. Tiotropium 18 µg once a day (OD) plus advair 250 µg two puffs twice a day (BID)
2. Tiotropium 18 µg OD plus salmeterol 25 µg/puffs, two puffs BID
3. Tiotropium 18 µg OD plus placebo inhaler, two pu
Sponsors
Ottawa Hospital Research Institute (Canada)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with moderate or severe COPD who have had at least one exacerbation of COPD in the last 12 months requiring antibiotics and/or oral steroids 2. Patients 35 years and older, either sex 3. Patients must have a history of at least 10-pack years of smoking, and documented chronic airflow obstruction with a forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio of less than 0.70, and an FEV1 of less than 65% of predicted
Exclusion criteria
Exclusion criteria: 1. Patients with a history of atopy, or asthma diagnosed before age 40 2. Patients less than 35 years of age (since patients younger than 35 are unlikely to have COPD) 3. Patients using chronic oral prednisone 4. Patients with known hypersensitivity or intolerance to tiotropum, advair, or salmeterol 5. Patients with a history of chronic congestive heart failure and known severe left ventricular dysfunction (which can mimic and be confused with COPD exacerbation) 6. Patients unable to provide informed consent due to language difficulties or cognitive impairment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients who experience a respiratory exacerbation in the three treatment groups within 52 weeks of randomisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in quality of life using Chronic Respiratory Disease Questionnaire (CRDQ) and St George's Respiratory Questionnaire (SGRQ) scores 2. Changes in dyspnoea using the baseline Transitional Dyspnoea Indexes (TDI) and Chronic Respiratory Questionnaire (CRQ) dyspnoea domain 3. Number of exacerbations resulting in urgent visits to healthcare provider; or emergency department visits 4. Total number of hospitalisations (all causes) 5. Time to first COPD exacerbation 6. Mean/median number of exacerbations in each treatment group 7. Absolute and relative changes in the morning pre-treatment FEV1 and FVC 8. Use of as-needed salbutamol (puffs/day) - as assessed by patient?s diary 9. Premature discontinuation of study medication, for reasons of diverse effects or lack of efficacy, as judged by patient?s physician | — |
Countries
Canada
Outcome results
None listed