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 (CAINAS)

NCT01001364 Phase 3 COMPLETED

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.

Details

Lead sponsor	Eurofarma Laboratorios S.A.
Phase	Phase 3
Status	COMPLETED
Enrolment	88
Start date	2010-02
Completion	2011-04

Conditions

• ASTHMA

Interventions

• Formoterol/Budesonide
• Foraseq

Primary outcomes

• The study primary endpoint will be the forced expiratory volume in 1 second (FEV1) at the final visit (FV) at each study arm. — 4 months

Countries

Brazil