Overview

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

Status:
Unknown status
Trial end date:
2012-12-01
Target enrollment:
0
Participant gender:
All
Summary
This study is to investigate and compare treatment efficacy with high and medium dose of fluticasone in combination with salmeterol in COPD patients.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Far Eastern Memorial Hospital
Collaborator:
Research Ethics Review Committee
Treatments:
Fluticasone
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Fluticasone-Salmeterol Drug Combination
Salmeterol Xinafoate
Xhance
Criteria
Inclusion Criteria:

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 Criteria:

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