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

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 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 Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Elpenhaler active - Diskus placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 3

Contacts and Locations

Study Locations

• Czechia
  • Nove Mesto, Czechia, 337 01
    • Pneumology and allergology surgery Voldusska 750
  • Prague, Czechia, 1536
    • Pneumology surgery Hostinskeho 1536
  • Prague, Czechia, 19800
    • Pneumology surgery Generala Janouska 902/17
  • Drahovice
    • Karlovy Vary, Drahovice, Czechia, 56001
      • Pneumology surgery Vitezna 201/31
  • Zizkov
    • Kutna Hora, Zizkov, Czechia
      • Pneumology surgery Vojtesska 237

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Elpen Pharmaceutical Co. Inc.
• Investigators: Principal Investigator: A Dindos, MD, Pneumology Surgery, Kojeticka 1021, 27711 Neratovicae

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): August 1, 2008
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: October 12, 2011
• First Submitted That Met QC Criteria: December 1, 2011
• First Posted (Estimated): December 2, 2011

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 2007-FLUSAL-EL-02; Sponsor ID (Other Identifier: FLUSAL-02); 2007-006670-29 (EudraCT Number); Sponsor FLUSAL-02 (Other Grant/Funding Number: Elpen Pharmaceutical Co Inc)