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

Quality of Life Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01657487
• Other study ID #: 099013-F
• Status: Recruiting
• Phase: Phase 4
• First received: August 2, 2012
• Last updated: August 3, 2012
• Start date: April 2010
• Est. completion date: December 2012

Study information

• Verified date: August 2012
• Source: Far Eastern Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Percentage of Annual Acute Exacerbation
• Quality of Life

Intervention

Drug:
• Fluticasone/Salmeterol high dose

Locations

Country	Name	City	State
Taiwan	Far Eastern Memorial Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Far Eastern Memorial Hospital	Research Ethics Review Committee

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	No
Secondary	Annual rate of acute exacerbations	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.	percentage of acute exacerbation in one year	Yes