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

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McGill University Health Center; McGill University Health Centre/Research Institute of the McGill University Health Centre
• Collaborator: GlaxoSmithKline
• Treatments: Fluticasone; Fluticasone Propionate, Salmeterol Xinafoate Drug Combination; Salmeterol Xinafoate; Xhance

Criteria

Inclusion Criteria:

• Diagnosis of stable COPD;

• 40 years or older;

• Smoking history of at least 10 pack-years;

• Forced Expiratory Volume in one second (FEV1) ≤ 70 % of predicted value and FEV1 / Forced Vital Capacity (FVC) < 0.70;

• Dyspnea ≥ 2 on the Medical Research Council (MRC) scale;

• At least 2 exacerbations requiring prednisone treatment in the past 3 years;

• Using a written action plan and having demonstrated adequate use of the self-administered antibiotic & prednisone (adequate use defined as prednisone started by the patient within 72 hours of symptom worsening and patient called the case-manager as recommended for following the response);

• Already on Advair BID (twice a day) as a maintenance therapy or able to switch over to Advair if already taking another combination medication (Symbicort) as maintenance therapy for COPD.

Exclusion Criteria:

• History of asthma or allergic rhinitis before the age of 40;

• Regular use of oxygen, oral corticosteroids, antibiotics;

• Unstable or life threatening co-morbid condition;

• Medical conditions or taking medications known to affect tremor and/or heart rate (HR).

• Pre-existing medical conditions or on concomitant medications contraindicated with salmeterol or fluticasone propionate (e.g. monoamine oxidase inhibitors and tricyclic antidepressants, beta-adrenergic receptor blocking agents, non potassium-sparing diuretics, inhibitors of cytochrome P450 (ritonavir, ketoconazole));

• On theophyllines.

• Colonized with pseudomonas aeruginosa.