Status:
TERMINATED
Effects of NIMV on the Health Status of Chronic Obstructive Pulmonary Disease (COPD )Patients
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40-90 years
Phase:
PHASE3
Brief Summary
In this proposal, we will implement a randomized controlled trial to determine whether nocturnal NIMV applied for 3 months: 1) improves (disease-specific) health related quality of life (HRQL) of COPD...
Detailed Description
COPD is one of the fastest growing conditions in the world, affecting over 16 million people in the US and over 1 million in Canada and costing society over $23 billion per annum (in the US). Its prev...
Eligibility Criteria
Inclusion
- A clinical diagnosis of COPD and meeting the American Thoracic Society's definition of COPD
- Age 55 years of age or older;
- A history of 10 pack-years or more of cigarette smoking;
- FEV1 to FVC ratio of less than 70% and a postbronchodilator FEV1 of less than 50% of predicted (at baseline and after the run-in);
- PaC02 of 45 mm Hg or greater measured at rest on room air (at baseline and after run-in)
Exclusion
- Coexisting medical conditions that make survival for at least 6 months unlikely;
- Refusal to participate;
- Cognitive impairment which makes it impossible to obtain informed consent;
- Patient on a lung transplant list;
- Clinical history of left ventricular heart failure;
- Body mass index of 35 kg/m2 or greater;
- (Obstructive) apnea-hypopnea index (AHI) of \> 15 on polysomnography;
- Evidence of Cheyne-Stokes respiration on polysomnography;
- Impaired left ventricular ejection (LVEF of \< 40% as determined on 2-D echocardiography);
- Patients who require rehospitalization, or an emergency visit for COPD during the run-in phase
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
End Date :
December 1 2004
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00114426
Start Date
January 1 2002
End Date
December 1 2004
Last Update
August 17 2005
Active Locations (1)
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1
University of Alberta Hospital
Edmonton, Alberta, Canada, T6J 2B7