Clinical trial NCT01131806: Comparing Treatment Efficacy With HD/MD Flu Plus Sal in Chronic Obstructive Pulmonary Disease (COPD) Patients
Official title: Comparing Treatment Efficacy With High and Medium Dose of Fluticasone in Combination With Salmeterol in COPD Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: chronic obstructive pulmonary disease
lung function change FEV1 FVC
acute exacerbation
life quality questionnaire
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
Collaborators: name: National Taiwan University Hospital
name: Far Eastern Memorial Hospital
First posted: 2010-05-27
Enrollment: 124
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The change of lung function parameters(FEV1&FVC) at different time points
timeFrame: baseline, week 12, 28 and 52
Secondary outcomes:
measure: Annual rate of acute exacerbations
timeFrame: 1 year
measure: Life quality evaluation
timeFrame: baseline, week 12, 28, and 52
measure: Annual incidence of community-acquired pneumonia
timeFrame: 1 year
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: Chest department, Veteran General Hospital-TAIPEI
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Diahn-Warng Perng, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.2165/00003495-200767160-00006.
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. doi: 10.1378/chest.124.3.834.
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. doi: 10.1183/09031936.03.00031402.