NCT01657487

Comparing Treatment Efficacy With High and Medium Dose of Fluticasone in Combination With Salmeterol in COPD Patients

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Far Eastern Memorial Hospital · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is to investigate and compare treatment efficacy with high and medium dose of fluticasone in combination with salmeterol in COPD patients.

Detailed description

Diagnosis and criteria for inclusion and exclusion: Inclusion: 1. Male or female outpatients aged 40 years≧ 2. Current or ex-smoker, with smoking history 10 pack≧- years 3. COPD (FEV1/FVC \< 70%) patients with post-bronchodilator FEV1 70% ≦predicted value, without bronchial reversibility (10% increase post ≦bronchodilator) Exclusion: 1. Diagnosis or suspicion of sleep apnea. 2. Concurrent rhinitis, eczema, and asthma. 3. Clinically overt bronchiectasis, lung cancer, active tuberculosis, or other known specific pulmonary disease. 4. A chest X-ray indicating diagnosis other than COPD that might interfere with the study. 5. Major disease abnormalities are uncontrolled on therapy. 6. Alcohol or medication abuse. 7. Patients had lower respiratory tract infections or received systemic steroid in the 4 weeks prior to the commencement of study. 8. Unable or unwilling to comply with all protocol Test product: fluticasone125 mcg/salmetrol 25 mcg ( Seretide 125 Evohaler ) fluticasone250 mcg/salmetrol 25 mcg ( Seretide 250 Evohaler ) Formulation: fluticasone/salmeterol, 125/25 mcg/puff Dose: 2 puffs bid

Conditions

• Percentage of Annual Acute Exacerbation
• Quality of Life

Interventions

Type	Name	Description
DRUG	Fluticasone/Salmeterol high dose

Timeline

• Start date: 2010-04-01
• Primary completion: 2012-09-01
• Completion: 2012-12-01
• First posted: 2012-08-06
• Last updated: 2012-08-06

Locations

1 site across 1 country: Taiwan