CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 552 enrolled
Drug / intervention
Formoterol/Budesonide +2 moredrug
Likely dose
Formoterol/Budesonide 400 µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01167010
NCT01167010Phase 3Completed
CompareCT.gov

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

Eurofarma Laboratorios S.A.·interventional·Posted Jul 21, 2010·Updated May 1, 2025

In Brief

A Phase 3 clinical trial evaluating Formoterol/Budesonide, Foraseq, and 1 other intervention for Asthma. Completed, enrolled 552 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesBrazil
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 21, 2010
Enrollment StartApr 1, 2011
Primary CompletionAug 1, 2011
Study CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 15.9 years ago

Interventions

Formoterol/Budesonidedrug

formoterol and budesonide will be administered at the 12/400 µg dosage, twice a da for 12 weeks.

Foraseqdrug

foraseq will be administered at the 12/400 µg dosage, twice a da for 12 weeks.

Aleniadrug

Alenia will be administered at the 12/400 µg dosage, twice a da for 12 weeks.