A randomised, double-blind, double-dummy, placebo controlled multi-centre study to evaluate the efficacy and safety of fluticasone furoate inhalation powder and fluticasone propionate inhalation powder in the treatment of asthma in adults and adolescents not currently treated with inhaled corticosteroids (FFA115285)
- Conditions
- asthmabronchial asthma10038716
- Registration Number
- NL-OMON37429
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
• Age 12 years and above.
• Bronchial asthma (acc. to NIH), at least 12 weeks.
• Evening FEV1 of at least 60% of normal.
• At least 12% and at least 200 ml reversibility of FEV1.
• Current anti-asthma treatment: non-corticosteroid controller and/or short-acting bronchodilator.
• Females of childbearing potential: reliable method of contraception.
• Life-threatening asthma within the last 10 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. No 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>Change in trough level FEV1 in week 24 compared to baseline.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Change compared to baseline in number of days without rescue medication,<br /><br>peakflow, symptom free days, asthma control, healthcare utilization, adverse<br /><br>events, exacerbations.</p><br>