Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Comparing Treatment Efficacy With High and Medium Dose of Fluticasone in Combination With Salmeterol in COPD Patients
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.
Status | Recruiting |
Enrollment | 124 |
Est. completion date | April 2011 |
Est. primary completion date | November 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years to 90 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Taiwan | Chest department, Veteran General Hospital-TAIPEI | Taipei City |
Lead Sponsor | Collaborator |
---|---|
Taipei Veterans General Hospital, Taiwan | Far Eastern Memorial Hospital, National Taiwan University Hospital |
Taiwan,
Calverley PM, Anderson JA, Celli B, Ferguson GT, Jenkins C, Jones PW, Yates JC, Vestbo J; TORCH investigators. Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease. N Engl J Med. 2007 Feb 22;356(8):775-89. — View Citation
Hanania NA, Darken P, Horstman D, Reisner C, Lee B, Davis S, Shah T. The efficacy and safety of fluticasone propionate (250 microg)/salmeterol (50 microg) combined in the Diskus inhaler for the treatment of COPD. Chest. 2003 Sep;124(3):834-43. — View Citation
Keating GM, McCormack PL. Salmeterol/fluticasone propionate: a review of its use in the treatment of chronic obstructive pulmonary disease. Drugs. 2007;67(16):2383-405. Review. — View Citation
Szafranski W, Cukier A, Ramirez A, Menga G, Sansores R, Nahabedian S, Peterson S, Olsson H. Efficacy and safety of budesonide/formoterol in the management of chronic obstructive pulmonary disease. Eur Respir J. 2003 Jan;21(1):74-81. Erratum in: Eur Respir J. 2003 May;21(5):912. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The change of lung function parameters(FEV1&FVC) at different time points | 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). | baseline, week 12, 28 and 52 | No |
Secondary | Annual rate of acute exacerbations | total numbers of acute exacerbation throughout the study year | 1 year | No |
Secondary | Life quality evaluation | The changes of Health-related quality of life assessed by CAT questionnaire before and after treatment. | baseline, week 12, 28, and 52 | No |
Secondary | Annual incidence of community-acquired pneumonia | Annual incidence of community-acquired pneumonia throughout the study year | 1 year | No |
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