Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 12:24 AM
Study NCT ID:
NCT05459194
Status:
COMPLETED
Last Update Posted:
2022-09-10
First Post:
2011-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Study of Fluticasone/Salmeterol Administered With Elpenhaler
Sponsor:
Elpen Pharmaceutical Co. Inc.
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
A pharmacodynamic study was designed in order to assess the therapeutic equivalence of the new formulation of Fluticasone/Salmeterol with the innovative one. The test and reference Fluticasone/Salmeterol formulations will be compared in terms of their bronchodilator effects in lung function. Forced Expiratory Volume in 1 second (FEV1) will be the primary efficacy measure and will be measured in such a way that a similar time-dependent increase in pulmonary function can be demonstrated for both Fluticasone/Salmeterol formulations in patients with asthma. In terms of safety comparison, repeated measurements of adverse events, vital signs, heart rate, blood hematology and biochemistry as well as ECG changes will enable the establishment of the similar safety profile of the test and reference Fluticasone/Salmeterol combinations.
The study will be conducted in a randomized, double-blind, double-dummy, placebo-controlled, 3x3 crossover fashion.
The study will be conducted in a randomized, double-blind, double-dummy, placebo-controlled, 3x3 crossover fashion.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: