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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-006670-29 | EudraCT Number | ||
| Sponsor ID | Other Identifier | FLUSAL-02 | |
| Sponsor FLUSAL-02 | Other Grant/Funding Number | Elpen Pharmaceutical Co Inc |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elpenhaler Active - Diskus Placebo | Experimental | Patients on treatment with both devices, Elpenhaler and Diskus, first active substance, second placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elpenhaler active - Diskus placebo | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary variable will be the 12-hour average FEV1 [area under the FEV1 versus time curve divided by 12 (FEV1 AUC0-12/12)]. | 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. | 0 (baseline), Visit 1 (3-7 days), Visit 2 (3-7 days), Telephone Contact Follow up (3-7 days) |
| Measure | Description | Time Frame |
|---|---|---|
| The FEV1 values over time for the 12-hour observation period | To compare the efficacy and safety profile of the two Fluticasone/Salmeterol formulations in patients with asthma. | 0 (baseline), Visit 1 (3-7 days), Visit 2 (3-7 days), Telephone Contact Follow up (3-7 days) |
| Time to peak FEV1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| A Dindos, MD | Pneumology Surgery, Kojeticka 1021, 27711 Neratovicae | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pneumology surgery Vitezna 201/31 | Karlovy Vary | Drahovice | 56001 | Czechia | ||
| Pneumology surgery Vojtesska 237 |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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|
To compare the effiacy and safety profile of the two Fluticasone/Salmeterol formulations in patients with asthma |
| 0 (baseline), Visit 1 (3-7 days), Visit 2 (3-7 days), Telephone Contact Follow up (3-7 days) |
| Time to peak FEV1 maximum value | same as FEV1 | same as FEV1 |
| Kutná Hora |
| Zizkov |
| Czechia |
| Pneumology and allergology surgery Voldusska 750 | New Town | 337 01 | Czechia |
| Pneumology surgery Hostinskeho 1536 | Prague | 1536 | Czechia |
| Pneumology surgery Generala Janouska 902/17 | Prague | 19800 | Czechia |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |