Optimal therapy of chronic obstructive pulmonary disease to prevent exacerbations and improve quality of life
| ISRCTN | ISRCTN29870041 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29870041 |
| Secondary identifying numbers | MCT-63139 |
- Submission date
- 17/06/2005
- Registration date
- 17/06/2005
- Last edited
- 25/02/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Shawn David Aaron
Scientific
Scientific
The Ottawa Hospital
Division of Respiratory Medicine
501 Smyth Road, Room 1812F
Ottawa, Ontario
K1H 8L6
Canada
| Phone | +1 613 739 6636 |
|---|---|
| saaron@ohri.ca |
Study information
| Study design | Randomised, double-blind, placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Optimal therapy of chronic obstructive pulmonary disease to prevent exacerbations and improve quality of life: a randomised, double-blind, placebo-controlled trial |
| Study objectives | To determine what combination of inhaled medications will most effectively prevent exacerbations of chronic obstructive pulmonary disease (COPD) and optimise disease-specific quality of life in patients with COPD. |
| Ethics approval(s) | Ottawa Hospital Research Ethics Board approval was obtained on the 9th April 2003 (amendments: November 4, 2003; January 29, 2004; June 22, 2004). |
| Health condition(s) or problem(s) studied | Chronic obstructive pulmonary disease (COPD) |
| Intervention | 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 puffs BID Pro re nata (PRN) (as needed) salbutamol use will be allowed throughout the trial period. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Tiotropium, advair, salmeterol |
| Primary outcome measure | Proportion of patients who experience a respiratory exacerbation in the three treatment groups within 52 weeks of randomisation. |
| Secondary outcome measures | 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 patients diary 9. Premature discontinuation of study medication, for reasons of diverse effects or lack of efficacy, as judged by patients physician |
| Overall study start date | 08/10/2003 |
| Completion date | 05/01/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 432 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 08/10/2003 |
| Date of final enrolment | 05/01/2006 |
Locations
Countries of recruitment
- Canada
Study participating centre
The Ottawa Hospital
Ottawa, Ontario
K1H 8L6
Canada
K1H 8L6
Canada
Sponsor information
Ottawa Hospital Research Institute (Canada)
Hospital/treatment centre
Hospital/treatment centre
501 Smyth Road
Ottawa, Ontario
K1H 8L6
Canada
| Phone | +1 613 798 5555 ext 16857 |
|---|---|
| rhanlon@ohri.ca | |
| Website | http://www.ohri.ca/ |
"ROR" |
https://ror.org/03c62dg59 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-63139)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 17/04/2007 | Yes | No |
