Efficacy and Safety Study of Fluticasone/Salmeterol Administered With Elpenhaler
Multicenter, Randomized, Double-blind, Placebo-controlled, 3-way Crossover, Single Dose Study, Comparing the Efficacy and Safety of Fluticasone/Salmeterol Administered With Elpenhaler Versus Seretide Diskus in Patients With Asthma
3 other identifiers
interventional
42
0 countries
N/A
Brief Summary
The aim of this study is to establish the therapeutic equivalence between the test (Fluticasone/Salmeterol administered with Elpenhaler®db, Rolenium®) and the reference formulation (Seretide®, administered with Diskus®), both containing 250/50μg of the Fluticasone/Salmeterol combination. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable asthma
Started Oct 2008
Shorter than P25 for not_applicable asthma
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 12, 2011
CompletedFirst Posted
Study publicly available on registry
July 14, 2022
CompletedSeptember 10, 2022
September 1, 2022
3 months
October 12, 2011
September 7, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
FEV1
12-hour average FEV1
8 days
Secondary Outcomes (1)
Adverse Events
8 days
Study Arms (2)
Test
ACTIVE COMPARATORFluticasone/Salmeterol Elpenhaler active vs Fluticasone/Salmeterol Diskus placebo
Refere
PLACEBO COMPARATORFluticasone/Salmeterol Elpenhaler placebo vs Fluticasone/Salmeterol Diskus active
Interventions
randomized, double-blind, double-dummy, placebo-controlled, 3-way crossover, single dose study, comparing the efficacy and safety of the Fluticasone/Salmeterol combination administered with Elpenhaler®db (Rolenium®) versus the innovative one (Seretide Diskus®)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Katalin Gömöri
Számítógépes Adatszolgáltató és Kereskedelmi Kft.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2011
First Posted
July 14, 2022
Study Start
October 1, 2008
Primary Completion
January 1, 2009
Study Completion
January 1, 2009
Last Updated
September 10, 2022
Record last verified: 2022-09