Effects of NIMV on the Health Status of Chronic Obstructive Pulmonary Disease (COPD )Patients

NCT00114426 | Terminated Phase 3

• 1 other identifier: MCT-52684
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 patients compared to a control group of patients treated with sham NIMV therapy (primary outcome); 2) improves exercise tolerance and walking capacity of COPD patients; and 3) improves heart rate variability and decreases sympathetic tone in COPD.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

randomized controlled trial; COPD

Outcome Measures

Primary Outcomes (1)

• Health Status

Secondary Outcomes (1)

• Heart Rate Variability

Interventions

non-invasive mechanical ventilation DEVICE

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, T6J 2B7, Canada

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Don D Sin, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 14, 2005
• First Posted: June 15, 2005
• Study Start: January 1, 2002
• Study Completion: December 1, 2004
• Last Updated: August 17, 2005

Record last verified: 2005-02

Locations

CA (1)