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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01657487

Enrollment

120

Registered

2012-08-06

Start date

2010-04-30

Completion date

2012-12-31

Last updated

2012-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Percentage of Annual Acute Exacerbation, Quality of Life

Keywords

COPD, Fluticasone/Salmeterol, high dose

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

Interventions

DRUGFluticasone/Salmeterol high dose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026