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

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ClinicalTrials.gov Identifier: NCT01657487
Recruitment Status : Unknown
Verified August 2012 by Shih-Lung Cheng, Far Eastern Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : August 6, 2012
Last Update Posted : August 6, 2012
Sponsor:
Collaborator:
Research Ethics Review Committee
Information provided by (Responsible Party):
Shih-Lung Cheng, Far Eastern Memorial Hospital

Tracking Information
First Submitted Date  ICMJE August 2, 2012
First Posted Date  ICMJE August 6, 2012
Last Update Posted Date August 6, 2012
Study Start Date  ICMJE April 2010
Estimated Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2012)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2012)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparing Treatment Efficacy With High and Medium Dose of Fluticasone in Combination With Salmeterol in COPD Patients
Official Title  ICMJE Not Provided
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Percentage of Annual Acute Exacerbation
  • Quality of Life
Intervention  ICMJE Drug: Fluticasone/Salmeterol high dose
Other Name: COPD patients treating with high dose of ICS (Fluticasone 1000ug/day) combined with Salmeterol (25ug/day)
Study Arms  ICMJE
  • Experimental: Fluticasone/salmeterol high dose
    COPD patients treating with high dose of ICS (Fluticasone 1000ug/day) combined with Salmeterol (25ug/day)
    Intervention: Drug: Fluticasone/Salmeterol high dose
  • Active Comparator: Fluticasone/Salmeterol medium dose
    COPD patients treating with medium dose of ICS (Fluticasone 500ug/day) combined with Salmeterol (25ug/day)
    Intervention: Drug: Fluticasone/Salmeterol high dose
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 3, 2012)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2012
Estimated Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01657487
Other Study ID Numbers  ICMJE 099013-F
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shih-Lung Cheng, Far Eastern Memorial Hospital
Study Sponsor  ICMJE Far Eastern Memorial Hospital
Collaborators  ICMJE Research Ethics Review Committee
Investigators  ICMJE Not Provided
PRS Account Far Eastern Memorial Hospital
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP