Comparing Treatment Efficacy With HD/MD Flu Plus Sal in Chronic Obstructive Pulmonary Disease (COPD) Patients
Recruitment status was: Recruiting
|Chronic Obstructive Pulmonary Disease||Drug: fluticasone/ salmeterol 125/25 mcg/puff Drug: fluticasone/ salmeterol 250/25 mcg/puff||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Comparing Treatment Efficacy With High and Medium Dose of Fluticasone in Combination With Salmeterol in COPD Patients|
- The change of lung function parameters(FEV1&FVC) at different time points [ Time Frame: 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).
- Annual rate of acute exacerbations [ Time Frame: 1 year ]total numbers of acute exacerbation throughout the study year
- Life quality evaluation [ Time Frame: 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 [ Time Frame: 1 year ]Annual incidence of community-acquired pneumonia throughout the study year
|Study Start Date:||December 2009|
|Estimated Study Completion Date:||April 2011|
|Estimated Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
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 Name: 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 Name: Seretide evohaler 250(GlaxoSmithKline)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01131806
|Contact: Diahn-Warng Perng, PhD||+886-2-28712121 ext firstname.lastname@example.org|
|Contact: Kang-Cheng Su, MD||+886-2-28712121 ext email@example.com|
|Chest department, Veteran General Hospital-TAIPEI||Recruiting|
|Taipei City, Taiwan, 112|
|Contact: Diahn-Warng Perng, PhD +886-2-28712121 ext 3194 firstname.lastname@example.org|
|Contact: Kang-Cheng Su, MD +886-2-28712121 ext 8928 email@example.com|
|Sub-Investigator: Kang-Cheng Su, MD|
|Principal Investigator:||Diahn-Warng Perng, PhD||Taipei Veterans General Hospital, Taiwan|