Comparing Treatment Efficacy With HD/MD Flu Plus Sal in Chronic Obstructive Pulmonary Disease (COPD) Patients
NCT ID: NCT01131806
Last Updated: 2010-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
124 participants
INTERVENTIONAL
2009-12-31
2011-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
fluticasone/ salmeterol 125/25 mcg/puff
fluticasone 125mcg/salmeterol 25mcg 2puffs/day x 52 weeks
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.
fluticasone/ salmeterol 250/25 mcg/puff
fluticasone 250mcg/salmeterol 25mcg 2puffs/day x 52 weeks
Interventions
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fluticasone/ salmeterol 125/25 mcg/puff
fluticasone 125mcg/salmeterol 25mcg 2puffs/day x 52 weeks
fluticasone/ salmeterol 250/25 mcg/puff
fluticasone 250mcg/salmeterol 25mcg 2puffs/day x 52 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
90 Years
ALL
No
Sponsors
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National Taiwan University Hospital
OTHER
Far Eastern Memorial Hospital
OTHER
Taipei Veterans General Hospital, Taiwan
OTHER_GOV
Responsible Party
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Veterans General Hospital-TAIPEI, Department of Chest
Principal Investigators
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Diahn-Warng Perng, PhD
Role: PRINCIPAL_INVESTIGATOR
Taipei Veterans General Hospital, Taiwan
Locations
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Chest department, Veteran General Hospital-TAIPEI
Taipei, Taiwan, Taiwan
Countries
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Central Contacts
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Facility Contacts
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References
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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. doi: 10.1056/NEJMoa063070.
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. doi: 10.2165/00003495-200767160-00006.
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. doi: 10.1378/chest.124.3.834.
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. doi: 10.1183/09031936.03.00031402.
Other Identifiers
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CM981016
Identifier Type: OTHER
Identifier Source: secondary_id
VGHIRB No. 98-10-16
Identifier Type: -
Identifier Source: org_study_id
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