Clinical trial NCT01657487: Comparing Treatment Efficacy With High and Medium Dose of Fluticasone in Combination With Salmeterol in COPD Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Percentage of Annual Acute Exacerbation
Quality of Life
Keywords: COPD
Fluticasone/Salmeterol
high dose
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Research Ethics Review Committee
First posted: 2012-08-06
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Eligibility 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

Primary outcomes:
measure: The changes of lung function parameters, including post bronchodilation forced expiratory volume in first second (FEV1) and forced vital capacity (FVC), before and after treatment.
timeFrame: Lung function change in one year
Secondary outcomes:
measure: Annual rate of acute exacerbations
timeFrame: percentage of acute exacerbation in one year
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Far Eastern Memorial Hospital
Study officials:
References: