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Strategy for Early Treatment of Exacerbations in COPD: Standing Prescriptions of Advair With a Written Action Plan in the Event of an Exacerbation

NCT02136875 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2014-05-14

No results posted yet for this study

Summary

The purpose of this pilot study is to determine whether early treatment of acute exacerbations of chronic obstructive pulmonary disease (AECOPD) with a combination therapy, Salmeterol + Fluticasone Propionate (SFP - Advair) will reduce the use of prednisone, known as the conventional treatment.

Primary objective: To determine whether early treatment with combination therapy (SFP) can reduce the use of prednisone (the conventional treatment) in the event of an AECOPD.

Secondary objectives:

* To evaluate the feasibility of this treatment approach and to provide pilot data (needed for a larger multi-centre clinical trial;
* To evaluate the feasibility and need of assessment during and after exacerbation onset, health-related quality of life and physical activity;
* To evaluate the safety of this approach; this is in terms of the delay in starting prednisone and an unfavourable outcome (ER visits and/or hospitalization).

Conditions

Interventions

DRUG

Double dose of Salmeterol + Fluticasone Propionate

BEHAVIORAL

Self-management education on the use of a self-administered prescription for exacerbation.

Patients will be instructed to start treatment within 48 hours of experiencing an acute exacerbation of COPD and/or after starting their self-administered prescription.

DRUG

Self-administered prescription

An Acute Exacerbation of COPD (AECOPD) is defined as a sustained worsening of dyspnea, cough or sputum production leading to an increase in the use of maintenance medication and/or supplementation with additional medication. In addition, exacerbations should be defined as either purulent or non-purulent. Standing prescriptions for exacerbation: 1\) Purulent exacerbation - Antibiotic: Avelox 400 mg daily for 5 days. 2a) Mild to moderate exacerbation - Combination therapy (SFP - Advair) to be increased as follows: If regular treatment is Advair 250/50 BID then dose should be increased to Advair 500/100 BID for 10 days; if regular treatment is Advair 500/50 BID then increase to Advair 1000/100 BID for 10 days. 2b) Severe exacerbation - Prednisone (oral): 40 mg once daily for 7-10 days

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

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

    lead OTHER

Principal Investigators

  • Jean Bourbeau, MD, FRCPC · McGill University Health Centre/Research Institute of the McGill University Health Centre

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • Canada

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02136875 on ClinicalTrials.gov