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

August 3, 2012 updated by: Shih-Lung Cheng, Far Eastern Memorial Hospital
This study is to investigate and compare treatment efficacy with high and medium dose of fluticasone in combination with salmeterol in COPD patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Diagnosis and criteria for inclusion and exclusion:

Inclusion:

  1. Male or female outpatients aged 40 years≧
  2. Current or ex-smoker, with smoking history 10 pack≧- years
  3. COPD (FEV1/FVC < 70%) patients with post-bronchodilator FEV1 70% ≦predicted value, without bronchial reversibility (10% increase post ≦bronchodilator)

Exclusion:

  1. Diagnosis or suspicion of sleep apnea.
  2. Concurrent rhinitis, eczema, and asthma.
  3. Clinically overt bronchiectasis, lung cancer, active tuberculosis, or other known specific pulmonary disease.
  4. A chest X-ray indicating diagnosis other than COPD that might interfere with the study.
  5. Major disease abnormalities are uncontrolled on therapy.
  6. Alcohol or medication abuse.
  7. Patients had lower respiratory tract infections or received systemic steroid in the 4 weeks prior to the commencement of study.
  8. Unable or unwilling to comply with all protocol

Test product:

fluticasone125 mcg/salmetrol 25 mcg ( Seretide 125 Evohaler ) fluticasone250 mcg/salmetrol 25 mcg ( Seretide 250 Evohaler ) Formulation: fluticasone/salmeterol, 125/25 mcg/puff Dose: 2 puffs bid

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 886
        • Recruiting
        • Far Eastern Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Shih-Lung Cheng, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female outpatients aged 40 years≧
  2. Current or ex-smoker, with smoking history 10 pack≧- years
  3. COPD (FEV1/FVC < 70%) patients with post-bronchodilator FEV1 70% ≦predicted value, without bronchial reversibility (10% increase post ≦bronchodilator)

Exclusion Criteria:

  1. Diagnosis or suspicion of sleep apnea.
  2. Concurrent rhinitis, eczema, and asthma.
  3. Clinically overt bronchiectasis, lung cancer, active tuberculosis, or other known specific pulmonary disease.
  4. A chest X-ray indicating diagnosis other than COPD that might interfere with the study.
  5. Major disease abnormalities are uncontrolled on therapy.
  6. Alcohol or medication abuse.
  7. Patients had lower respiratory tract infections or received systemic steroid in the 4 weeks prior to the commencement of study.
  8. Unable or unwilling to comply with all protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fluticasone/salmeterol high dose
COPD patients treating with high dose of ICS (Fluticasone 1000ug/day) combined with Salmeterol (25ug/day)
Drug: Fluticasone/Salmeterol high dose
Other Names:
  • COPD patients treating with high dose of ICS (Fluticasone 1000ug/day) combined with Salmeterol (25ug/day)
Active Comparator: Fluticasone/Salmeterol medium dose
COPD patients treating with medium dose of ICS (Fluticasone 500ug/day) combined with Salmeterol (25ug/day)
Drug: Fluticasone/Salmeterol high dose
Other Names:
  • COPD patients treating with high dose of ICS (Fluticasone 1000ug/day) combined with Salmeterol (25ug/day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Lung function change in one year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Annual rate of acute exacerbations
Time Frame: percentage of acute exacerbation in one year
  1. Annual rate of acute exacerbations
  2. The number of use of rescue medication
  3. Annual incidence of community-acquired pneumonia
  4. The changes of Health-related quality of life assessed by questionnaire (CAT or SGRQ) before and after treatment.
percentage of acute exacerbation in one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Far Eastern Memorial Hospital

Collaborators

Research Ethics Review Committee

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Anticipated)

September 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

August 2, 2012

First Submitted That Met QC Criteria

August 3, 2012

First Posted (Estimate)

August 6, 2012

Study Record Updates

Last Update Posted (Estimate)

August 6, 2012

Last Update Submitted That Met QC Criteria

August 3, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 099013-F

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Quality of Life

Clinical Trials on Fluticasone/Salmeterol high dose

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe