Efficacy and Safety Study of Fluticasone/Salmeterol Administered With Elpenhaler

NCT ID: NCT05459194

Last Updated: 2022-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2009-01-31

Brief Summary

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.

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Test

Fluticasone/Salmeterol Elpenhaler active vs Fluticasone/Salmeterol Diskus placebo

Group Type: ACTIVE_COMPARATOR

RP - TA

Intervention Type: DEVICE

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®)

Refere

Fluticasone/Salmeterol Elpenhaler placebo vs Fluticasone/Salmeterol Diskus active

Group Type: PLACEBO_COMPARATOR

RP - TA

Intervention Type: DEVICE

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®)

Interventions

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®)

Intervention Type: DEVICE

Other Intervention Names

Rolenium; Seretide

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Elpen Pharmaceutical Co. Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katalin Gömöri

Role: PRINCIPAL_INVESTIGATOR

Számítógépes Adatszolgáltató és Kereskedelmi Kft.

Related Links

https://pubmed.ncbi.nlm.nih.gov/17523742/

PMID: 17523742 DOI: 10.2165/00044011-200525010-00001

Other Identifiers

2008-000193-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

Sponsor ID

Identifier Type: OTHER

Identifier Source: secondary_id

2007-FLUSAL-EL-01

Identifier Type: -

Identifier Source: org_study_id