Comparing Treatment Efficacy With HD/MD Flu Plus Sal in Chronic Obstructive Pulmonary Disease (COPD) Patients

Sponsor

Taipei Veterans General Hospital, Taiwan (Other)

Overall Status

Unknown status

CT.gov ID

NCT01131806

Collaborator

National Taiwan University Hospital (Other), Far Eastern Memorial Hospital (Other)

124

Enrollment

Location

Arms

Duration (Months)

7.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Chronic obstructive pulmonary disease is characterized as inflammatory airway with not fully reversible airflow limitation.Combination treatment with inhaled corticosteroid (ICS) and long-acting β2 agonists (LABA)attains an improved control of symptoms and lung function, that are superior to those associated with either drug alone. However, the treatment efficacy between high and medium dose of inhaled corticosteroid in combination of LABA is still unknown. The aim of the current study is to investigate the treatment efficacy with high and medium dose of fluticasone in combination with salmeterol in COPD patients.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Drug: fluticasone/ salmeterol 125/25 mcg/puff Drug: fluticasone/ salmeterol 250/25 mcg/puff	Phase 4

Detailed Description

Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and the use of health care resources worldwide. It is characterized by chronic progressive symptoms, airflow obstruction, and impaired health status, which is worse in those who have frequent, acute episodes of symptom exacerbation. Treatment for COPD is focused on minimizing risk factors, improving symptoms, and preventing exacerbations.

Pulmonary inflammation is the key factor in COPD. Inhaled long-acting β2 agonists (LABA) improve airflow obstruction, control of symptoms, and health status in patients with COPD over 3 to 4 months. Inhaled corticosteroids (ICS) are currently the most popular anti-inflammatory medications for use in symptomatic patients with COPD. Previous large scaled randomized control study discovered long-term use of ICS didn't modified annual decline of lung function in COPD patients, but may reduce the frequency of exacerbations, especially when combined with an LABA.

Combination treatment with ICS and LABA has been widely used for patients with COPD and attains an improved control of symptoms and lung function, with no greater risk of side-effects than that of treatment with either component alone. Combined ICS/LABA will result in better treatment effects that are superior to those associated with either drug alone. However, the treatment efficacy between high and medium dose of inhaled corticosteroid in combination of LABA is still unknown. The aim of the current study is to investigate the treatment efficacy with high and medium dose of fluticasone in combination with salmeterol in COPD patients.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

124 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2009

Anticipated Primary Completion Date :

Nov 1, 2010

Anticipated Study Completion Date :

Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: MD Flu/Sal fluticasone125 mcg/ salmeterol 25 mcg 2puffs (medium dose group) inhaled twice daily; salbutamol evohaler allowed from 100 to 400 mcg for inhalation as needed basis.	Drug: fluticasone/ salmeterol 125/25 mcg/puff fluticasone 125mcg/salmeterol 25mcg 2puffs/day x 52 weeks Other Names: Seretide evohaler 125(GlaxoSmithKline)
Experimental: HD Flu/Sal fluticasone 250 mcg/salmeterol 25 mcg 2puffs (high dose group) inhaled twice daily; salbutamol evohaler allowed from 100 to 400 mcg for inhalation as needed basis.	Drug: fluticasone/ salmeterol 250/25 mcg/puff fluticasone 250mcg/salmeterol 25mcg 2puffs/day x 52 weeks Other Names: Seretide evohaler 250(GlaxoSmithKline)

Arm

Intervention/Treatment

Active Comparator: MD Flu/Sal

fluticasone125 mcg/ salmeterol 25 mcg 2puffs (medium dose group) inhaled twice daily; salbutamol evohaler allowed from 100 to 400 mcg for inhalation as needed basis.

Drug: fluticasone/ salmeterol 125/25 mcg/puff

fluticasone 125mcg/salmeterol 25mcg 2puffs/day x 52 weeks

Other Names:

Seretide evohaler 125(GlaxoSmithKline)

Experimental: HD Flu/Sal

fluticasone 250 mcg/salmeterol 25 mcg 2puffs (high dose group) inhaled twice daily; salbutamol evohaler allowed from 100 to 400 mcg for inhalation as needed basis.

Drug: fluticasone/ salmeterol 250/25 mcg/puff

fluticasone 250mcg/salmeterol 25mcg 2puffs/day x 52 weeks

Other Names:

Seretide evohaler 250(GlaxoSmithKline)

Outcome Measures

Primary Outcome Measures

The change of lung function parameters(FEV1&FVC) at different time points [baseline, week 12, 28 and 52]
The changes of lung function parameters, including post bronchodilation forced expiratory volume in first second (FEV1) and forced vital capacity (FVC), at different time points, including baseline, 12th week, 28th week, and ending (52th week).

Secondary Outcome Measures

Annual rate of acute exacerbations [1 year]
total numbers of acute exacerbation throughout the study year
Life quality evaluation [baseline, week 12, 28, and 52]
The changes of Health-related quality of life assessed by CAT questionnaire before and after treatment.
Annual incidence of community-acquired pneumonia [1 year]
Annual incidence of community-acquired pneumonia throughout the study year

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or female outpatients aged ≧ 40 years.
Current or ex-smoker, with smoking history ≧ 10 pack- years
COPD (FEV1/FVC < 70%) patients with post-bronchodilator FEV1 ≦ 70% predicted value, without bronchial reversibility (≦10% increase post bronchodilator).

Exclusion Criteria:

Diagnosis or suspicion of sleep apnea
Concurrent rhinitis, eczema, and asthma
Clinically overt bronchiectasis, lung cancer, active tuberculosis, or other known specific pulmonary disease
A chest X-ray indicating diagnosis other than COPD that might interfere with the study.
Major disease abnormalities are uncontrolled on therapy.
Alcohol or medication abuse.
Patients had lower respiratory tract infections or received systemic steroid in the 4 weeks prior to the commencement of study.
Unable or unwilling to comply with all protocol specified procedures.