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

This study is currently recruiting participants.
Verified August 2012 by Far Eastern Memorial Hospital
Sponsor:
Collaborator:
Research Ethics Review Committee
Information provided by (Responsible Party):
Shih-Lung Cheng, Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01657487
First received: August 2, 2012
Last updated: August 3, 2012
Last verified: August 2012
  Purpose

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


Condition Intervention Phase
Percentage of Annual Acute Exacerbation
Quality of Life
Drug: Fluticasone/Salmeterol high dose
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Far Eastern Memorial Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    We will compare the lung function changed in COPD patients treating with different doses of Fluticasone (500 and 1000ug)


Secondary Outcome Measures:
  • Annual rate of acute exacerbations [ Time Frame: percentage of acute exacerbation in one year ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 120
Study Start Date: April 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: COPD patients treating with high dose of ICS (Fluticasone 1000ug/day) combined with Salmeterol (25ug/day)

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

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01657487

Locations
Taiwan
Far Eastern Memorial Hospital Recruiting
Taipei, Taiwan, 886
Contact: Shih-Lung Cheng, MD, PhD    888-2-89667000 ext 2816    ntuhwyh61@yahoo.com.tw   
Principal Investigator: Shih-Lung Cheng, MD, PhD         
Sponsors and Collaborators
Far Eastern Memorial Hospital
Research Ethics Review Committee
  More Information

No publications provided

Responsible Party: Shih-Lung Cheng, Division of Pulmonary Medicine, Department of Internal Medicine, Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT01657487     History of Changes
Other Study ID Numbers: 099013-F
Study First Received: August 2, 2012
Last Updated: August 3, 2012
Health Authority: Taiwan: Research Ethics Committee

Keywords provided by Far Eastern Memorial Hospital:
COPD
Fluticasone/Salmeterol
high dose

Additional relevant MeSH terms:
Salmeterol
Albuterol
Fluticasone
Fluticasone, salmeterol drug combination
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Tocolytic Agents
Reproductive Control Agents
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Sympathomimetics

ClinicalTrials.gov processed this record on April 23, 2014