Efficacy and Safety Study of Fluticasone/Salmeterol Admin... | NCT05459194

Studies
Efficacy and Safety Study of Fluticasone/Salmeterol Administered With Elpenhaler

NCT05459194

Sponsor

Elpen Pharmaceutical Co. Inc.

Status

Completed

Last Update Posted

Sep 10, 2022Actual

Enrollment

42Actual

Phase

Not Applicable

Conditions

Asthma

Interventions

RP - TA

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2008-000193-21	EudraCT Number
Sponsor ID	Other Identifier	FLUSAL-01

Status Module

Record Verification Date

Sep 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2008Actual

Primary Completion Date

Jan 2009Actual

Completion Date

Jan 2009Actual

First Submitted Date

Oct 12, 2011

First Submission Date that Met QC Criteria

Jul 12, 2022

First Posted Date

Jul 14, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 7, 2022

Last Update Posted Date

Sep 10, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Test	Active Comparator	Fluticasone/Salmeterol Elpenhaler active vs Fluticasone/Salmeterol Diskus placebo	Device: RP - TA
Refere	Placebo Comparator	Fluticasone/Salmeterol Elpenhaler placebo vs Fluticasone/Salmeterol Diskus active	Device: RP - TA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RP - TA	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®)

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Katalin Gömöri	Számítógépes Adatszolgáltató és Kereskedelmi Kft.	Principal Investigator

Locations

Not provided

Label	URL
PMID: 17523742 DOI: 10.2165/00044011-200525010-00001	View source

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided