drugset / Trial / NCT02136875

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

NCT02136875

NaSingle-groupOpen-labelTreatment

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).

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Fluticasone propionate Other / unclassified 500 ug Inhaled
Subject Fluticasone propionate Other / unclassified 1000 ug Inhaled
Subject Salmeterol Other / unclassified 100 ug Inhaled
Background Moxifloxacin Small molecule 400 mg
Background Prednisone Other / unclassified 40 mg