Optimal therapy of chronic obstructive pulmonary disease to prevent exacerbations and improve quality of life: a randomised, double-blind, placebo-controlled trial

Ottawa Hospital Research Institute (Canada)0 sites432 target enrollmentJune 17, 2005

Overview

No summary available.

Registry

who.int

Start Date

June 17, 2005

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional

Sex

All

Sponsor

Ottawa Hospital Research Institute (Canada)

•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

•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