Status:
COMPLETED
Single Dose Study of the Fluticasone/Salmeterol (500/50 μg) Administered With Elpenhaler® Versus Diskus®
Lead Sponsor:
Elpen Pharmaceutical Co. Inc.
Conditions:
Asthma
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
The aim of this study is to establish the therapeutic equivalence between the test (Fluticasone/Salmeterol administered with Elpenhaler®, Rolenium®) and the reference formulation (Seretide®, administe...
Detailed Description
In case of inhaled products, it is not possible to follow the classic scheme, based on similarity of plasma concentration-time behavior of parent drug in assessing bioequivalence. For this reason, a ...
Eligibility Criteria
Inclusion
- age 18-65 years,
- diagnosis of asthma of 6 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 30 days,
- PIF 30 - 90 lt/min and
- informed consent.
Exclusion
- history of other pulmonary disease,
- asthma exacerbation or respiratory infection within the previous 4 weeks,
- hospitalization for acute asthmatic symptoms requiring parenteral steroids or oral steroid dose increase, within the previous 30 days,
- 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 β-blocker, of a NSAID or an antiallergic/antihistaminic medication within 2 weeks prior to screening visit.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01484210
Start Date
March 1 2008
End Date
October 1 2008
Last Update
November 1 2023
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Pneumology surgery Vitezna 201/31
Karlovy Vary, Drahovice, Czechia, 56001
2
Pneumology surgery Vojtesska 237
Kutná Hora, Zizkov, Czechia
3
Pneumology and allergology surgery Voldusska 750
New Town, Czechia, 337 01
4
Pneumology surgery Hostinskeho 1536
Prague, Czechia, 1536