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A Non-inferiority, Comparative Study Between Foraseq®, Eurofarma´s Formoterol/Budesonide and Alenia® in Asthma

NCT01167010 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 552

Last updated 2025-05-01

Study results available
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Summary

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.

Conditions

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.

Sponsors & Collaborators

  • Eurofarma Laboratorios S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2011-08-31
Completion
2012-02-29

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01167010 on ClinicalTrials.gov