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

NCT ID: NCT01202097

Last Updated: 2025-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

334 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-05-31

Brief Summary

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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

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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.

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.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Salmeterol/Fluticasone

Group Type EXPERIMENTAL

Salmeterol/Fluticasone

Intervention Type DRUG

Seretide

Group Type ACTIVE_COMPARATOR

Seretide

Intervention Type DRUG

Interventions

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Salmeterol/Fluticasone

Intervention Type DRUG

Seretide

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eurofarma Laboratorios S.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital de Clinicas UFPR

Curitiba, PR, , Brazil

Site Status

Centro de Referencia em Enfermidades Respiratoria e Alergica

Salvador, BA, , Brazil

Site Status

Centro de Estudos de Pneumologia FMABC

São Paulo, , Brazil

Site Status

IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada

São Paulo, , Brazil

Site Status

Stelmach Pesquisa Clinica

São Paulo, , Brazil

Site Status

Clinica de Alergia Martti Antila

Sorocaba, SP, , Brazil

Site Status

Countries

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Brazil

Other Identifiers

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EF113

Identifier Type: -

Identifier Source: org_study_id