Single Dose Study of the Fluticasone/Salmeterol (500/50 μg) Administered With Elpenhaler® Versus Diskus®
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®, administered with Diskus®), both containing 500/50μg of the Fluticasone/Salmeterol combination.
The study will be conducted in a randomized, double-blind, double-dummy, 2x2 crossover fashion.
|Study Design:||Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Phase III Therapeutic Evaluation 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.|
- The primary variable will be the 12-hour average FEV1 [area under the FEV1 versus time curve divided by 12 (FEV1 AUC0-12/12)]. [ Time Frame: 0 (baseline), Visit 1 (3-7 days), Visit 2 (3-7 days), Telephone Contact Follow up (3-7 days) ] [ Designated as safety issue: Yes ]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.
- The FEV1 values over time for the 12-hour observation period [ Time Frame: 0 (baseline), Visit 1 (3-7 days), Visit 2 (3-7 days), Telephone Contact Follow up (3-7 days) ] [ Designated as safety issue: Yes ]To compare the efficacy and safety profile of the two Fluticasone/Salmeterol formulations in patients with asthma.
- Time to peak FEV1 [ Time Frame: 0 (baseline), Visit 1 (3-7 days), Visit 2 (3-7 days), Telephone Contact Follow up (3-7 days) ] [ Designated as safety issue: Yes ]To compare the effiacy and safety profile of the two Fluticasone/Salmeterol formulations in patients with asthma
- Time to peak FEV1 maximum value [ Time Frame: same as FEV1 ] [ Designated as safety issue: Yes ]same as FEV1
|Study Start Date:||March 2008|
|Study Completion Date:||October 2008|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
Experimental: Elpenhaler Active - Diskus Placebo
Patients on treatment with both devices, Elpenhaler and Diskus, first active substance, second placebo.
Drug: Elpenhaler active - Diskus placebo
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.
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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01484210
|Pneumology surgery Vitezna 201/31|
|Karlovy Vary, Drahovice, Czech Republic, 56001|
|Pneumology surgery Vojtesska 237|
|Kutna Hora, Zizkov, Czech Republic|
|Pneumology and allergology surgery Voldusska 750|
|Nove Mesto, Czech Republic, 337 01|
|Pneumology surgery Generala Janouska 902/17|
|Prague, Czech Republic, 19800|
|Pneumology surgery Hostinskeho 1536|
|Prague, Czech Republic, 1536|
|Principal Investigator:||A Dindos, MD||Pneumology Surgery, Kojeticka 1021, 27711 Neratovicae|