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

Sponsor
Far Eastern Memorial Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01657487
Collaborator
Research Ethics Review Committee (Other)
120
Enrollment
1
Location
2
Arms
32
Duration (Months)
3.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Fluticasone/Salmeterol high dose
 Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date :
Apr 1, 2010
Anticipated Primary Completion Date :
Sep 1, 2012
Anticipated Study Completion Date :
Dec 1, 2012

Arms and Interventions

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)

    		•

    Outcome Measures

    Primary Outcome Measures

    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. [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)

    Secondary Outcome Measures

    1. Annual rate of acute exacerbations [percentage of acute exacerbation in one year]

      Annual rate of acute exacerbations The number of use of rescue medication Annual incidence of community-acquired pneumonia The changes of Health-related quality of life assessed by questionnaire (CAT or SGRQ) before and after treatment.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Far Eastern Memorial Hospital Taipei Taiwan 886

    Sponsors and Collaborators

    • Far Eastern Memorial Hospital
    • Research Ethics Review Committee

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shih-Lung Cheng, Division of Pulmonary Medicine, Department of Internal Medicine, Far Eastern Memorial Hospital
    ClinicalTrials.gov Identifier:
    NCT01657487
    Other Study ID Numbers:
    • 099013-F
    First Posted:
    Aug 6, 2012
    Last Update Posted:
    Aug 6, 2012
    Last Verified:
    Aug 1, 2012
    Keywords provided by Shih-Lung Cheng, Division of Pulmonary Medicine, Department of Internal Medicine, Far Eastern Memorial Hospital
    COPD
    Fluticasone/Salmeterol
    high dose
    Additional relevant MeSH terms:
    Fluticasone
    Xhance
    Salmeterol Xinafoate
    Fluticasone-Salmeterol Drug Combination

    Study Results

    No Results Posted as of Aug 6, 2012