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ISRCTN
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ISRCTN29870041
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ClinicalTrials.gov identifier
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Public title
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Optimal therapy of chronic obstructive pulmonary disease to prevent exacerbations and improve quality of life
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Scientific title
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Optimal therapy of chronic obstructive pulmonary disease to prevent exacerbations and improve quality of life: a randomised, double-blind, placebo-controlled trial
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Acronym
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N/A
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Serial number at source
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MCT-63139
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Ottawa Hospital Research Ethics Board approval was obtained on the 9th April 2003 (amendments: November 4, 2003; January 29, 2004; June 22, 2004).
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Study design
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Randomised, double-blind, placebo-controlled trial
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Countries of recruitment
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Canada
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Disease/condition/study domain
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Chronic obstructive pulmonary disease (COPD)
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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08/10/2003
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Anticipated end date
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05/01/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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432
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Interventions
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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.
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Primary outcome measure(s)
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Proportion of patients who experience a respiratory exacerbation in the three treatment groups within 52 weeks of randomisation.
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Secondary outcome measure(s)
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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
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Sources of funding
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Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-63139)
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Trial website
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Publications
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2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17310045
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Contact name
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Dr
Shawn David
Aaron
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Address
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The Ottawa Hospital
Division of Respiratory Medicine
501 Smyth Road, Room 1812F
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City/town
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Ottawa, Ontario
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Zip/Postcode
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K1H 8L6
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Country
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Canada
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Tel
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+1 613 739 6636
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Fax
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+1 613 739 6266
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Email
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saaron@ohri.ca
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Sponsor
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Ottawa Hospital Research Institute (Canada)
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Address
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501 Smyth Road
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City/town
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Ottawa, Ontario
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Zip/Postcode
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K1H 8L6
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Country
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Canada
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Tel
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+1 613 798 5555 ext 16857
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Fax
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+1 613 761 4920
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Email
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rhanlon@ohri.ca
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Sponsor website:
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http://www.ohri.ca/
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Date applied
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17/06/2005
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Last edited
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25/02/2009
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Date ISRCTN assigned
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17/06/2005
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