A multicenter, randomized, double-blind, double-dummy, 2-way crossover, single dose study, comparing the efficacy and safety of the Fluticasone/Salmeterol (500/50 µg) combination administered with Elpenhaler® (Rolenium®) versus the innovative one (Seretide Diskus®) in patients with asthma
- Conditions
- Comparison of efficacy and safety of the investigational medicinal product with comparator at chronic asthma with stabile treatment by corticosteroids.MedDRA version: 9.1Level: LLTClassification code 10003561Term: Asthma, unspecified
- Registration Number
- EUCTR2007-006670-29-CZ
- Lead Sponsor
- Elpen Pharmaceutical Co. Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Age 18-65
Diagnosis of asthma of 6 or more months
FEV1 = 50% and =80% predicted
Reversibility of at least 12%
Stable asthma for at least 4 weeks
Inhaled steroids (ICS) at a stable dose within the previous 4 weeks
PIF 30 - 90 lt/min
Informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
History of other pulmonary disease
Asthma exacerbation or respiratory infection within the previous 4 weeks
Hospitalization for acute asthmatic symptoms or oral steroid treatment within the previous 8 weeks
Heavy smokers
Change of asthma medication within the previous 4 weeks
Seasonal asthma alone
History of severe heart disease
Pregnancy or lactation
Use of a ß-blocker, of a NSAID or an antiallergic/antihistaminic medication within 2 weeks prior to screening visit.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To establish the therapeutic equivalence between the Fluticasone/Salmeterol combination administered with Elpenhaler® (Rolenium®) and the innovative one (Seretide Diskus®) in terms of their bronchodilator effect in lung function. ;Secondary Objective: To compare the safety profile of the two Fluticasone/Salmeterol formulations in patients with asthma.;Primary end point(s): The primary variable for the comparison of the two Fluticasone/Salmeterol formulations will be the 12-hour average FEV1 [area under the FEV1 versus time curve divided by 12 (FEV1 AUC0-12/12)].
- Secondary Outcome Measures
Name Time Method