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

Far Eastern Memorial Hospital

Status and phase: Unknown; Phase 4

Conditions: Quality of Life; Percentage of Annual Acute Exacerbation

Treatments: Drug: Fluticasone/Salmeterol high dose

Study type: Interventional

Funder types: Other

Identifiers

NCT01657487

099013-F

Details and patient eligibility

About

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

Full 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

Enrollment: 120 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Fluticasone/salmeterol high dose

Experimental group

Description:

COPD patients treating with high dose of ICS (Fluticasone 1000ug/day) combined with Salmeterol (25ug/day)

Treatment:

Drug: Fluticasone/Salmeterol high dose

Fluticasone/Salmeterol medium dose

Active Comparator group

Description:

COPD patients treating with medium dose of ICS (Fluticasone 500ug/day) combined with Salmeterol (25ug/day)

Treatment:

Drug: Fluticasone/Salmeterol high dose