Condition category
Respiratory
Date applied
17/06/2005
Date assigned
17/06/2005
Last edited
25/02/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Shawn David Aaron

ORCID ID

Contact details

The Ottawa Hospital
Division of Respiratory Medicine
501 Smyth Road
Room 1812F
Ottawa
Ontario
K1H 8L6
Canada
+1 613 739 6636
saaron@ohri.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MCT-63139

Study information

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

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.

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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 names

Tiotropium, advair, salmeterol

Primary outcome measures

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 patient’s diary
9. Premature discontinuation of study medication, for reasons of diverse effects or lack of efficacy, as judged by patient’s physician

Overall trial start date

08/10/2003

Overall trial end date

05/01/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

432

Participant 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

Recruitment start date

08/10/2003

Recruitment end date

05/01/2006

Locations

Countries of recruitment

Canada

Trial participating centre

The Ottawa Hospital
Ottawa, Ontario
K1H 8L6
Canada

Sponsor information

Organisation

Ottawa Hospital Research Institute (Canada)

Sponsor details

501 Smyth Road
Ottawa
Ontario
K1H 8L6
Canada
+1 613 798 5555 ext 16857
rhanlon@ohri.ca

Sponsor type

Hospital/treatment centre

Website

http://www.ohri.ca/

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-63139)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17310045

Publication citations

  1. Results

    Aaron SD, Vandemheen KL, Fergusson D, Maltais F, Bourbeau J, Goldstein R, Balter M, O'Donnell D, McIvor A, Sharma S, Bishop G, Anthony J, Cowie R, Field S, Hirsch A, Hernandez P, Rivington R, Road J, Hoffstein V, Hodder R, Marciniuk D, McCormack D, Fox G, Cox G, Prins HB, Ford G, Bleskie D, Doucette S, Mayers I, Chapman K, Zamel N, FitzGerald M, , Tiotropium in combination with placebo, salmeterol, or fluticasone-salmeterol for treatment of chronic obstructive pulmonary disease: a randomized trial., Ann. Intern. Med., 2007, 146, 8, 545-555.

Additional files

Editorial Notes