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Optimal therapy of chronic obstructive pulmonary disease to prevent exacerbations and improve quality of life
ISRCTN ISRCTN29870041
DOI 10.1186/ISRCTN29870041
ClinicalTrials.gov identifier
EudraCT number
Public title Optimal therapy of chronic obstructive pulmonary disease to prevent exacerbations and improve quality of life
Scientific title Optimal therapy of chronic obstructive pulmonary disease to prevent exacerbations and improve quality of life: a randomised, double-blind, placebo-controlled trial
Acronym N/A
Serial number at source MCT-63139
Study hypothesis 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.
Lay summary
Ethics approval Ottawa Hospital Research Ethics Board approval was obtained on the 9th April 2003 (amendments: November 4, 2003; January 29, 2004; June 22, 2004).
Study design Randomised, double-blind, placebo-controlled trial
Countries of recruitment Canada
Disease/condition/study domain Chronic obstructive pulmonary disease (COPD)
Participants - 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
Participants - 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
Anticipated start date 08/10/2003
Anticipated end date 05/01/2006
Status of trial Completed
Patient information material
Target number of participants 432
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 puffs BID

Pro re nata (PRN) (as needed) salbutamol use will be allowed throughout the trial period.
Primary outcome measure(s) Proportion of patients who experience a respiratory exacerbation in the three treatment groups within 52 weeks of randomisation.
Secondary outcome measure(s) 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 patientís diary
9. Premature discontinuation of study medication, for reasons of diverse effects or lack of efficacy, as judged by patientís physician
Sources of funding Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-63139)
Trial website
Publications 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17310045
Contact name Dr  Shawn David  Aaron
  Address The Ottawa Hospital
Division of Respiratory Medicine
501 Smyth Road, Room 1812F
  City/town Ottawa, Ontario
  Zip/Postcode K1H 8L6
  Country Canada
  Tel +1 613 739 6636
  Fax +1 613 739 6266
  Email saaron@ohri.ca
Sponsor Ottawa Hospital Research Institute (Canada)
  Address 501 Smyth Road
  City/town Ottawa, Ontario
  Zip/Postcode K1H 8L6
  Country Canada
  Tel +1 613 798 5555 ext 16857
  Fax +1 613 761 4920
  Email rhanlon@ohri.ca
  Sponsor website: http://www.ohri.ca/
Date applied 17/06/2005
Last edited 25/02/2009
Date ISRCTN assigned 17/06/2005
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