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

• Status: Unknown status
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taipei Veterans General Hospital, Taiwan
• Collaborators: Far Eastern Memorial Hospital; National Taiwan University Hospital
• Treatments: Fluticasone; Fluticasone Propionate, Salmeterol Xinafoate Drug Combination; Fluticasone-Salmeterol Drug Combination; Salmeterol Xinafoate; Xhance

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.