A Randomised, Double-Blind, Double-Dummy, Parallel-Group, Multicentre Study to assess efficacy and safety of Fluticasone Furoate (FF)/GW642444 Inhalation Powder and Fluticasone Propionate FP)/Salmeterol Inhalation Powder in the Treatment of Persistent Asthma in Adults and Adolescents.
- Conditions
- AsthmaPersistent Asthma10006436
- Registration Number
- NL-OMON34054
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 62
* Age 12 years and above.
* Bronchial asthma (acc. to NIH), at least 12 weeks.
* Evening FEV1 of 40-85%.
* At least 12% and at least 200ml reversibility of FEV1.
* Inhaled corticosteroid for at least 12 weeks and be maintained on a medium dose (e.g. FP 250 mcg twice daily) for at least the last 4 weeks.
* Females of childbearing potential: reliable method of contraception.
* Life-threatening asthma within the last 5 years.
* Respiratory infection within the last 4 weeks.
* Asthma exacerbation within the last 12 weeks.
* Visual evidence of candidiasis.
* History of severe milk protein allergy.
* Potent CYP3A4 inhibitor within the last 4 weeks.
* Current smoker or a smoking history of 10 pack years. Use of inhaled tobacco products within the past 3 months.
* Pregnancy or breastfeeding.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>FEV1 0-4 h and at trough level.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Questionnaires quality of life, asthma control, healthcare utilization, adverse<br /><br>events, cortisol excretion.</p><br>