A Comparative Study Between Foraseq And Formoterol/Budesonide Inhalation Capsules in Patients With Asthma — CAINAS  

ASTHMA Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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; ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• ASTHMA

• NCT number: NCT01001364
• Study type: Interventional
• Source: Eurofarma Laboratorios S.A.
• Status: Completed
• Phase: Phase 3
• Start date: February 2010
• Completion date: April 2011