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

Brief Summary

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.”

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, 2×2 crossover fashion.

  • Study Type: Interventional
  • Study Design: Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
  • Study Primary Completion Date: August 2008

Detailed Clinical Trial 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.

Interventions Used in this Clinical Trial

  • 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.

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Elpenhaler Active – Diskus Placebo
    • Patients on treatment with both devices, Elpenhaler and Diskus, first active substance, second placebo.

Outcome Measures for this Clinical Trial

Primary Measures

  • The primary variable will be the 12-hour average FEV1 [area under the FEV1 versus time curve divided by 12 (FEV1 AUC0-12/12)].
    • Time Frame: 0 (baseline), Visit 1 (3-7 days), Visit 2 (3-7 days), Telephone Contact Follow up (3-7 days)
      Safety Issue?: Yes

Secondary Measures

  • The FEV1 values over time for the 12-hour observation period
    • Time Frame: 0 (baseline), Visit 1 (3-7 days), Visit 2 (3-7 days), Telephone Contact Follow up (3-7 days)
      Safety Issue?: Yes
  • Time to peak FEV1
    • Time Frame: 0 (baseline), Visit 1 (3-7 days), Visit 2 (3-7 days), Telephone Contact Follow up (3-7 days)
      Safety Issue?: Yes
  • Time to peak FEV1 maximum value
    • Time Frame: same as FEV1
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Elpen Pharmaceutical Co. Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • A Dindos, MD, Principal Investigator, Pneumology Surgery, Kojeticka 1021, 27711 Neratovicae


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