Optimal therapy of chronic obstructive pulmonary disease to prevent exacerbations and improve quality of life

ISRCTN	ISRCTN29870041
DOI	https://doi.org/10.1186/ISRCTN29870041
Protocol serial number	MCT-63139
Sponsor	Ottawa Hospital Research Institute (Canada)
Funder	Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: 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

The Ottawa Hospital
Division of Respiratory Medicine
501 Smyth Road, Room 1812F
Ottawa, Ontario
K1H 8L6
Canada

Phone	+1 613 739 6636
Email	saaron@ohri.ca

Study information

Primary study design	Interventional
Study design	Randomised, double-blind, placebo-controlled trial
Secondary study design	Randomised controlled trial
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
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Tiotropium, advair, salmeterol
Primary outcome measure(s)	Proportion of patients who experience a respiratory exacerbation in the three treatment groups within 52 weeks of randomisation.
Key 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 patients diary 9. Premature discontinuation of study medication, for reasons of diverse effects or lack of efficacy, as judged by patients physician
Completion date	05/01/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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