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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Elpen Pharmaceutical Co. Inc.
ClinicalTrials.gov Identifier:
NCT01484210
First received: October 12, 2011
Last updated: August 30, 2012
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: Elpenhaler active - Diskus placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Elpen Pharmaceutical Co. Inc.:

Primary Outcome 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) ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome 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) ] [ Designated as safety issue: Yes ]
    To compare the efficacy and safety profile of the two Fluticasone/Salmeterol formulations in patients with asthma.

  • 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) ] [ Designated as safety issue: Yes ]
    To compare the effiacy and safety profile of the two Fluticasone/Salmeterol formulations in patients with asthma

  • Time to peak FEV1 maximum value [ Time Frame: same as FEV1 ] [ Designated as safety issue: Yes ]
    same as FEV1


Enrollment: 28
Study Start Date: March 2008
Study Completion Date: October 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01484210

Locations
Czech Republic
Pneumology surgery Vitezna 201/31
Karlovy Vary, Drahovice, Czech Republic, 56001
Pneumology surgery Vojtesska 237
Kutna Hora, Zizkov, Czech Republic
Pneumology and allergology surgery Voldusska 750
Nove Mesto, Czech Republic, 337 01
Pneumology surgery Generala Janouska 902/17
Prague, Czech Republic, 19800
Pneumology surgery Hostinskeho 1536
Prague, Czech Republic, 1536
Sponsors and Collaborators
Elpen Pharmaceutical Co. Inc.
Investigators
Principal Investigator: A Dindos, MD Pneumology Surgery, Kojeticka 1021, 27711 Neratovicae
  More Information

Additional Information:
No publications provided

Responsible Party: Elpen Pharmaceutical Co. Inc.
ClinicalTrials.gov Identifier: NCT01484210     History of Changes
Other Study ID Numbers: 2007-FLUSAL-EL-02, 2007-006670-29, Sponsor ID, Sponsor FLUSAL-02
Study First Received: October 12, 2011
Last Updated: August 30, 2012
Health Authority: Czech Republic: State Institute for Drug Control

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Salmeterol
Albuterol
Fluticasone, salmeterol drug combination
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014