Efficacy and Safety Study of Fluticasone/Salmeterol Administered With Elpenhaler

September 7, 2022 updated by: Elpen Pharmaceutical Co. Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Test
Fluticasone/Salmeterol Elpenhaler active vs Fluticasone/Salmeterol Diskus placebo
Device: RP - TA
randomized, double-blind, double-dummy, placebo-controlled, 3-way crossover, single dose study, comparing the efficacy and safety of the Fluticasone/Salmeterol combination administered with Elpenhaler®db (Rolenium®) versus the innovative one (Seretide Diskus®)
Other Names:
  • Seretide
  • Rolenium
Placebo Comparator: Refere
Fluticasone/Salmeterol Elpenhaler placebo vs Fluticasone/Salmeterol Diskus active
Device: RP - TA
randomized, double-blind, double-dummy, placebo-controlled, 3-way crossover, single dose study, comparing the efficacy and safety of the Fluticasone/Salmeterol combination administered with Elpenhaler®db (Rolenium®) versus the innovative one (Seretide Diskus®)
Other Names:
  • Seretide
  • Rolenium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FEV1
Time Frame: 8 days
12-hour average FEV1
8 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 8 days
Number of Adverse Events during the study
8 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elpen Pharmaceutical Co. Inc.

Investigators

  • Principal Investigator: Katalin Gömöri, Számítógépes Adatszolgáltató és Kereskedelmi Kft.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2008

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

October 12, 2011

First Submitted That Met QC Criteria

July 12, 2022

First Posted (Actual)

July 14, 2022

Study Record Updates

Last Update Posted (Actual)

September 10, 2022

Last Update Submitted That Met QC Criteria

September 7, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-FLUSAL-EL-01
  • 2008-000193-21 (EudraCT Number)
  • Sponsor ID (Other Identifier: FLUSAL-02)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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