NCT02136875

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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).

Detailed description

BACKGROUND Acute exacerbations of COPD (AECOPD) are of major importance since they are associated with adverse effects on morbidity, health status, and costs. Conventional treatment includes the use of antibiotics and oral corticosteroids (OCS). However, OCS is associated with significant side effects. This is of considerable importance since exacerbation occurs on average 2 to 4 times per year in COPD patients. Alternative treatment such as high dose inhaled corticosteroids has also been shown to be effective in the treatment of AECOPD. Recently, studies have clearly demonstrated the effect of combination therapy (SFP) on key inflammatory cells and a marked enhance anti-inflammatory effect when compared to inhaled corticosteroids alone. Inhaled corticosteroids have a high level of topical anti-inflammatory activity and a low level of systemic. Additionally, combination therapy with inhaled corticosteroids and long-acting β2-adrenoceptor agonists (SFP) appears to produce significant anti-inflammatory effects in COPD airways that are not seen when inhaled or oral steroids are used alone. This could offer a potential for an alternative treatment to oral corticosteroids in AECOPD. RATIONALE None of the inhaled treatments is likely to be adopted and to replace the use of OCS for the treatment of AECOPD unless it is used promptly at the onset of symptom worsening. Early treatment has been shown to have clinical importance in accelerating symptom recovery and reducing hospital admission. Recently, the investigators have demonstrated that the early treatment of AECOPD can be achieved by the implementation of a written action plan as part of a self-management education. The use of action plans helps COPD patients recognize symptom changes, implement self-care and self-initiate a customized prescription (antibiotics \& oral steroids) in the event of an exacerbation. Self-management education programs with a written action plan that includes standing prescriptions with combination therapy (SFP) in the event of an exacerbation may be promising in reducing the use of prednisone in AECOPD, the conventional treatment.

Conditions

• COPD
• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-07-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2014-05-13
• Last updated: 2014-05-14

Locations

1 site across 1 country: Canada