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

July 7, 2010 updated by: Taipei Veterans General Hospital, Taiwan

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

124

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 Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Taipei City, Taiwan, 112
        • Recruiting
        • Chest department, Veteran General Hospital-TAIPEI
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Kang-Cheng Su, MD

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 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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
Active Comparator: MD Flu/Sal
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.
Drug: fluticasone/ salmeterol 125/25 mcg/puff
fluticasone 125mcg/salmeterol 25mcg 2puffs/day x 52 weeks
Other Names:
  • Seretide evohaler 125(GlaxoSmithKline)
Experimental: HD Flu/Sal
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.
Drug: fluticasone/ salmeterol 250/25 mcg/puff
fluticasone 250mcg/salmeterol 25mcg 2puffs/day x 52 weeks
Other Names:
  • Seretide evohaler 250(GlaxoSmithKline)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change of lung function parameters(FEV1&FVC) at different time points
Time Frame: baseline, week 12, 28 and 52
The changes of lung function parameters, including post bronchodilation forced expiratory volume in first second (FEV1) and forced vital capacity (FVC), at different time points, including baseline, 12th week, 28th week, and ending (52th week).
baseline, week 12, 28 and 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Annual rate of acute exacerbations
Time Frame: 1 year
total numbers of acute exacerbation throughout the study year
1 year
Life quality evaluation
Time Frame: baseline, week 12, 28, and 52
The changes of Health-related quality of life assessed by CAT questionnaire before and after treatment.
baseline, week 12, 28, and 52
Annual incidence of community-acquired pneumonia
Time Frame: 1 year
Annual incidence of community-acquired pneumonia throughout the study year
1 year

Collaborators and Investigators

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

Sponsor

Taipei Veterans General Hospital, Taiwan

Collaborators

National Taiwan University Hospital
Far Eastern Memorial Hospital

Investigators

  • Principal Investigator: Diahn-Warng Perng, PhD, Taipei Veterans General Hospital, Taiwan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2009

Primary Completion (Anticipated)

November 1, 2010

Study Completion (Anticipated)

April 1, 2011

Study Registration Dates

First Submitted

May 25, 2010

First Submitted That Met QC Criteria

May 26, 2010

First Posted (Estimate)

May 27, 2010

Study Record Updates

Last Update Posted (Estimate)

July 8, 2010

Last Update Submitted That Met QC Criteria

July 7, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VGHIRB No. 98-10-16
  • CM981016 (Other Identifier: Veterans General Hospital-TAIPEI)

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.

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