Phase IV Study; Strategy for Early Treatment of Exacerbations in COPD: Standing Prescriptions of Advair With a Written Action Plan in the Event of an Exacerbation
Abstract
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: COPD, Chronic Obstructive Pulmonary Disease.
Primary outcome: Percentage of participants with treatment success (no need of prednisone).
Enrollment: 37 participants.
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 37 participants or records.
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