Status:

COMPLETED

Innovations in Treating COPD Exacerbations: Pilot Project on Action Plans Using New Technology.

Lead Sponsor:

McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborating Sponsors:

GlaxoSmithKline

Conditions:

COPD

Eligibility:

All Genders

40+ years

Phase:

NA

Brief Summary

The purpose of this project is to conduct a pilot study evaluating the feasibility and potential benefits of a phone assessment/reporting system (tele-system) in addition to a written action plan and ...

Detailed Description

BACKGROUND: Chronic Obstructive Pulmonary Disease (COPD) is the 4th leading cause of death in Canada and the only chronic disease where mortality rates continue to climb. Acute exacerbations are commo...

Eligibility Criteria

Inclusion

  • Patients will be adults with COPD at high risk for exacerbations
  • Post bronchodilator spirometry FEV1 \<80% pred. and FEV1/FVC \<0.70
  • Aged ≥ 40 yrs
  • Smoking ≥ 10 pack-years
  • 1 or more exacerbations requiring antibiotic or prednisone in the last year. (This is the population with the highest chance of having another exacerbation
  • Combination therapy LABA-ICS (Advair) with or without an anticholinergic (Spiriva or Atrovent) and a rescue SABA (Ventolin)

Exclusion

  • Combination therapy LABA-ICS other than Advair
  • Home oxygen for 18-24 hours/day
  • Chronic CO2 retention
  • Previous NIMV/MV
  • Cognitive impairment
  • Does not speak English or French fluently
  • Severe co-morbidities such as bronchiectasis with recurrent infections, severe left congestive heart failure
  • Survival \<6 months
  • Any significant medical condition other than COPD that may also result in dyspnea (e.g. unstable angina, BMI \> 40).

Key Trial Info

Start Date :

October 15 2013

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 29 2017

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT02275078

Start Date

October 15 2013

End Date

November 29 2017

Last Update

August 20 2018

Active Locations (1)

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1

Montreal Chest Institute

Montreal, Quebec, Canada, H2X2P4