A Non- Inferiority Comparative Study Between Seretide® an... | NCT01202097

Studies
A Non- Inferiority Comparative Study Between Seretide® and Salmeterol/Fluticasone Eurofarma in Patients with Asthma

NCT01202097

Sponsor

Eurofarma Laboratorios S.A.

Status

Completed

Last Update Posted

Mar 31, 2025Actual

Enrollment

334Actual

Phase

Phase 3

Conditions

Asthma

Interventions

Salmeterol/Fluticasone
Seretide

Countries

Brazil

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

Status Module

Record Verification Date

Sep 2010

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

Aug 2011

Primary Completion Date

Not provided

Completion Date

May 2012Actual

First Submitted Date

Sep 14, 2010

First Submission Date that Met QC Criteria

Sep 14, 2010

First Posted Date

Sep 15, 2010Estimated

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

Mar 26, 2025

Last Update Posted Date

Mar 31, 2025Actual

Description Module

Brief Summary

The primary objective will be to compare the formulations regarding their impact on the pulmonary function of persistent asthma patients and the secondary objective will be the clinical control of the disease's symptoms.

Detailed Description

Primary endpoint: Forced expiratory volume in 1 second (FEV1) at the final visit.

Secondary endpoints: Expiratory Flow Peak (EFP), symptoms score, FEV1 throughout the study, use of rescue medication, compliance with inhaler use, inhaler acceptance and preference, and frequency of the observed adverse events.

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

334Actual

Label	Type	Description	Intervention Names
Salmeterol/Fluticasone	Experimental		Drug: Salmeterol/Fluticasone
Seretide	Active Comparator		Drug: Seretide

Name	Type	Description	Arm Group Labels	Other Names
Salmeterol/Fluticasone	Drug		Salmeterol/Fluticasone
Seretide

Measure	Description	Time Frame
Forced expiratory volume in 1 second (FEV1) at the final visit.

Measure	Description	Time Frame
Expiratory Flow Peak (EFP)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Sign the ICF
≥ 12 years old
Have a persistent asthma diagnosis, as per GINA classification,18 with symptoms for at least 6 months and clinically stable for at least 1 month with the ACQ-7 test (please see Appendix C) ≤ 3.0
Current use of inhaled corticosteroid (up to 1000 µg of beclomethasone dipropionate) whether combined or not with long-term β2-adrenergics and relief medication (salbutamol or equivalent)
Initial FEV1 of at least 40% of the normal value expected
Blood cortisol evaluation within the normal limits.

Exclusion Criteria:

Use of oral or parenteral corticosteroid within the last 3 previous months to the study
Hospitalization needed due to asthma within the last 3 previous months to the study
Active smokers, defined as the consumption of cigarettes, pipes, cigars or any other form of smoking in any amount within the last 3 months
Presence of severe co-morbidities, such as cardiovascular, renal, liver, neurological, neoplastic, hematological, infectious, dermatological, neurological or psychiatric disease or chronic respiratory disease other than asthma
Recent (<6 months) or expected participation during this study in other clinical trials involving drugs of any nature or in studies consisting of any - Intolerance or allergy to any component of the drugs evaluated in the study
Pregnant or lactating women
Chronic use of routine β-blockers, orally or intravenously, including ophthalmic solutions.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Hospital de Clinicas UFPR		Curitiba, PR			Brazil
Centro de Referencia em Enfermidades Respiratoria e Alergica

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

ID	Term
D000068299	Salmeterol Xinafoate
D000420	Albuterol
D004983	Ethanolamines
D000605	Amino Alcohols