NCT01001364

A Comparative Study Between Foraseq and Formoterol/Budesonide Inhalation Capsules in Patients with Asthma

A Phase III, Randomized, Open-Label, Non-Inferiority Comparative Study Between Foraseq Inhalation Capsules 12/200 Μg and Formoterol/ Budesonide Inhalation Capsules 12/200 Μg Eurofarma in Patients with Asthma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Eurofarma Laboratorios S.A. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This study primary objective is to compare the impact of two products containing budesonide and formoterol as individual capsules with inhalation powder for the pulmonary function of subjects with persistent asthma.

Detailed description

This study primary objective is to compare the impact of two products containing budesonide and formoterol as individual capsules with inhalation powder for the pulmonary function of subjects with persistent asthma. This is a non-inferiority study, which hypothesis is that there is no difference on the pulmonary function measure between the groups studied at its end. Therefore, the study primary endpoint will be the forced expiratory volume in 1 second (FEV1) at the final visit (FV) at each study arm. This study secondary objective is to compare the impact on the clinical control of two products containing budesonide and formoterol as individual capsules with inhalation powder in subjects with persistent asthma. The secondary endpoints considered for this study are: * Score of asthma control questionnaire (ACQ-7) 34 at the end of the study ; * Peak of expiratory flow (PEF) throughout the study; * Symptoms score at the end of the study; * FEV1 throughout the study; * Treatment safety, including serum cortisol dosage; * Frequency of observed adverse events. Some eligibility criteria: * Current use of inhaled corticosteroids (equivalent to beclometasone dipropionate 1000µg) associated or not to long-acting β2-adrenergics and relief medication (salbutamol or equivalent); * Diagnosis of mild to moderate persistent asthma, as per the ARIA classification, 35 with symptoms for at least 6 months, clinically stable for at least 1 month with ACQ-7 test34 (see Attachment D) \< 3.0;

Conditions

• ASTHMA

Interventions

Type	Name	Description
DRUG	Formoterol/Budesonide	formoterol will be administered at the 12 µg dosage, twice a day, and budesonide will be administered at the 200 µg dose, also twice a day for 12 weeks.
DRUG	Foraseq	formoterol will be administered at the 12 µg dosage, twice a day, and budesonide will be administered at the 200 µg dose, also twice a day for 12 weeks.

Timeline

• Start date: 2010-02-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2009-10-26
• Last updated: 2025-03-19

Locations

1 site across 1 country: Brazil