Single Dose Study of the Fluticasone/Salmeterol (500/50 μg) Administered With Elpenhaler® Versus Diskus®

Asthma Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01484210
• Other study ID #: 2007-FLUSAL-EL-02
• Secondary ID: 2007-006670-29Sp
• Status: Completed
• Phase: Phase 3
• Start date: March 2008
• Est. completion date: October 2008

Study information

• Verified date: November 2011
• Source: Elpen Pharmaceutical Co. Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®, 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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: October 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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 ß-blocker, of a NSAID or an antiallergic/antihistaminic medication within 2 weeks prior to screening visit.

Related Conditions & MeSH terms

• Asthma

Intervention

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.

Locations

Country	Name	City	State
Czechia	Pneumology surgery Vitezna 201/31	Karlovy Vary	Drahovice
Czechia	Pneumology surgery Vojtesska 237	Kutna Hora	Zizkov
Czechia	Pneumology and allergology surgery Voldusska 750	Nove Mesto
Czechia	Pneumology surgery Generala Janouska 902/17	Prague
Czechia	Pneumology surgery Hostinskeho 1536	Prague

Sponsors (1)

Lead Sponsor	Collaborator
Elpen Pharmaceutical Co. Inc.

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Secondary	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)
Secondary	Time to peak FEV1	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)
Secondary	Time to peak FEV1 maximum value	same as FEV1	same as FEV1