A Non-inferiority, Comparative Study Between Foraseq®, Eurofarma´s Formoterol/Budesonide and Alenia® in Asthma

Launched by EUROFARMA LABORATORIOS S.A. · Jul 20, 2010

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Sign the ICF;
• • ≥ 12 years old;
• • Have a diagnosis of mild to moderate persistent asthma diagnosis, as per the GINA classification (www.ginasthma.com),18 with symptoms for at least 6 months and clinically stable for at least 1 month with the ACQ-7 test \<3,0;
• • Current use of inhaled corticosteroid (equivalent to 1000 µg of beclomethasone dipropionate) whether associated or not with long-term β2 adrenergics and relief medication (salbutamol or equivalent);
• • Initial FEV1 of at least 50% of the normal value expected;
• • Serum cortisol evaluation within the normal limits
• Exclusion Criteria:
• • Use of oral or parenteral corticosteroid within the last 3 months before the study;
• • Hospitalization needed due to asthma within the last 3 months before the study;
• • Active smokers, defined as the consumption of cigarettes, pipes, cigars, or any other form of smoking in any amount within the last 3 months;
• • Presence of serious co-morbidities, such as cardiovascular, renal, liver, neurological, neoplastic, hematological, infectious, dermatologic, neurological, or psychiatric disease, or chronic respiratory disease other than asthma;
• • Recent participation (\<6 months) or expected participation in other clinical trials involving drug products of any nature or in studies consisting of any form of intervention for the treatment of asthma;
• • Intolerance or allergy to any component of the drugs evaluated in the study;
• • Pregnant or lactating women;
• • Chronic use of routine β-blockers orally or intravenously, including ophthalmic solutions.