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

Phase 4

• Conditions: Percentage of Annual Acute Exacerbation; Quality of Life
• Interventions: Drug: Fluticasone/Salmeterol high dose

• Registration Number: NCT01657487
• Lead Sponsor: Far Eastern Memorial Hospital

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

Study Timeline

• Study Start: 2010-04
• Status Verified: 2012-08
• Study First Submitted: 2012-08-02
• Study First Submitted QC: 2012-08-03
• Last Update Submitted: 2012-08-03
• Study First Posted: 2012-08-06
• Last Update Posted: 2012-08-06
• Primary Completion: 2012-09
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluticasone/salmeterol high dose	Fluticasone/Salmeterol high dose	COPD patients treating with high dose of ICS (Fluticasone 1000ug/day) combined with Salmeterol (25ug/day)
Fluticasone/Salmeterol medium dose	Fluticasone/Salmeterol high dose	COPD patients treating with medium dose of ICS (Fluticasone 500ug/day) combined with Salmeterol (25ug/day)

Primary Outcome Measures

Name	Time	Method
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.	Lung function change in one year	We will compare the lung function changed in COPD patients treating with different doses of Fluticasone (500 and 1000ug)

Secondary Outcome Measures

Name	Time	Method
Annual rate of acute exacerbations	percentage of acute exacerbation in one year	1. Annual rate of acute exacerbations; 2. The number of use of rescue medication; 3. Annual incidence of community-acquired pneumonia; 4. The changes of Health-related quality of life assessed by questionnaire (CAT or SGRQ) before and after treatment.

Trial Locations

Locations (1)

Far Eastern Memorial Hospital; 🇨🇳 Taipei, Taiwan