FindTrial
Sign In

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-006670-29-CZ
Enrollment
Unknown
Registered
2008-01-23
Start date
2008-03-27
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Comparison of efficacy and safety of the investigational medicinal product with comparator at chronic asthma with stabile treatment by corticosteroids. MedDRA version: 9.1 Level: LLT Classification code 10003561 Term: Asthma, unspecified

Interventions

Trade Name: Rolenium® Product Name: Rolenium® Pharmaceutical Form: Inhalation powder, pre-dispensed INN or Proposed INN: FLUTICASONE PROPIONATE CAS Number: 80474142 Concentration unit: µg microgram(s)

Sponsors

Elpen Pharmaceutical Co. Inc.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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)].—

Countries

Czech Republic

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026