Trial Synopsis

A Non-inferiority, Comparative Study Between Foraseq®,
Eurofarma´s Formoterol/Budesonide and Alenia® in Asthma
Status: Completed
Study Phase: Phase 3
Start Date: April 2011 | Completion Date: February 2012
Condition(s): Asthma
Full Title of Study
A Phase III, Randomized, Non-inferiority, Open-label, Comparative Study Between
Foraseq® Inhalation Capsules, Eurofarma's Single Formoterol / Budesonide
Inhalation Capsule and Single Alenia® Inhalation Capsule in Asthmatic Patients
Overview
The primary objective will be to compare the Eurofarma and Alenia formulations
regarding their impact on the pulmonary function of mild to moderate persistent
asthma patients and the secondary objective will be to compare the three study
formulations regarding the clinical control of the symptoms and the patients'
compliance to the treatment.
Study Details
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study,
Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose:
Treatment
Investigator Details
Lead Sponsor: Eurofarma Laboratorios S.A.
Trial Location Details
Facility: Centro de Referencia em Enfermidades Respiratoria e Alergica Salvador, Brazil
Facility: Hospital de Clinicas UFPR Curitiba, Brazil
Facility: Clinica de Alergia Martti Antila Sorocaba, Brazil
Facility: IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada São Paulo, Brazil
Facility: Stelmach Pesquisa Clinica São Paulo, Brazil
Interventions
Drug: Formoterol/Budesonide
formoterol and budesonide will be administered at the 12/400 µg dosage, twice a da for 12 weeks.
Drug: Foraseq
foraseq will be administered at the 12/400 µg dosage, twice a da for 12 weeks.
Drug: Alenia
Alenia will be administered at the 12/400 µg dosage, twice a da for 12 weeks.
Information Source
ID Number: EF111
NCT Identifier: NCT01167010
Health Authority: Array
Full Source of Clinical Trial Data: https://clinicaltrials.gov/show/NCT01167010
ClinicalTrials.gov processed this data on September 30, 2016
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