Comparing Treatment Efficacy With High and Medium Dose of Fluticasone in Combination With Salmeterol in COPD Patients

NCT01657487 | Unknown Phase 4 DMC

• 1 other identifier: 099013-F
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to investigate and compare treatment efficacy with high and medium dose of fluticasone in combination with salmeterol in COPD patients.

Conditions

Percentage of Annual Acute Exacerbation; Quality of Life

Keywords

COPD; Fluticasone/Salmeterol; high dose

Outcome Measures

Primary Outcomes (1)

• The changes of lung function parameters, including post bronchodilation forced expiratory volume in first second (FEV1) and forced vital capacity (FVC), before and after treatment.

  We will compare the lung function changed in COPD patients treating with different doses of Fluticasone (500 and 1000ug)

  Lung function change in one year

Secondary Outcomes (1)

• Annual rate of acute exacerbations

  percentage of acute exacerbation in one year

Study Arms (2)

Fluticasone/salmeterol high dose

EXPERIMENTAL

COPD patients treating with high dose of ICS (Fluticasone 1000ug/day) combined with Salmeterol (25ug/day)

Drug: Fluticasone/Salmeterol high dose

Fluticasone/Salmeterol medium dose

ACTIVE COMPARATOR

COPD patients treating with medium dose of ICS (Fluticasone 500ug/day) combined with Salmeterol (25ug/day)

Drug: Fluticasone/Salmeterol high dose

Interventions

Fluticasone/Salmeterol high dose DRUG

Also known as: COPD patients treating with high dose of ICS (Fluticasone 1000ug/day) combined with Salmeterol (25ug/day)

Fluticasone/Salmeterol medium dose; Fluticasone/salmeterol high dose

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Far Eastern Memorial Hospital: lead
• Research Ethics Review Committee: collaborator

Study Sites (1)

Far Eastern Memorial Hospital

Taipei, 886, Taiwan

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Fluticasone; Salmeterol Xinafoate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division of Pulmonary Medicine, Department of Internal Medicine

Study Record Dates

• First Submitted: August 2, 2012
• First Posted: August 6, 2012
• Study Start: April 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2012
• Last Updated: August 6, 2012

Record last verified: 2012-08

Locations

TW (1)