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

Launched by EUROFARMA LABORATORIOS S.A. · Oct 23, 2009

Keywords

ClinConnect 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. 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 pr...

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Eligibility criteria

• Inclusion Criteria:
• • Sign ICF (see Attachment A);
• • Age ≥12 years old
• • 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;
• • Current use of inhaled corticosteroids (equivalent to beclometasone dipropionate 1000µg) associated or not to long-acting β2-adrenergics and relief medication (salbutamol or equivalent);
• • Initial FEV1 of at least 50% of the normal value estimated.
• • Serum cortisol evaluation within the normal values
• Exclusion Criteria:
• • Use of oral or parenteral corticosteroids within the last 3 months;
• • Need of hospitalization due to asthma within the last 3 months;
• • Active tabagism, defined as the use of cigarettes, pipe, cigar or any other type in any amount within the last 3 months;
• • Severe co-morbidity, such as cardiovascular, renal, liver, neurologic, neoplastic, blood, infectious, dermatologic, neurologic, psychiatric or chronic respiratory diseases, other than asthma;
• • Recent participation (\<6 months) or planned participation, during this study, on other clinical trials involving drugs of any nature or under studies of any type of intervention for the asthma treatment;
• • Intolerance or allergy to any of the compounds of the drugs evaluated on the study;
• • Pregnancy or lactation;
• • Chronic use of routine oral or intravenous β-blocker drugs, even ophthalmic solutions.