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

Taipei Veterans General Hospital

Status and phase: Unknown; Phase 4

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: fluticasone/ salmeterol 125/25 mcg/puff; Drug: fluticasone/ salmeterol 250/25 mcg/puff

Study type: Interventional

Funder types: Other

Identifiers

NCT01131806

VGHIRB No. 98-10-16

CM981016 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 124 estimated patients

Sex: All

Ages: 40 to 90 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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124 participants in 2 patient groups

MD Flu/Sal

Active Comparator group

Description:

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.

Treatment:

Drug: fluticasone/ salmeterol 125/25 mcg/puff

HD Flu/Sal

Experimental group

Description:

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.

Treatment:

Drug: fluticasone/ salmeterol 250/25 mcg/puff