A Study Comparative of Formoterol/Fluticasone Foraseq® and Fluticasone in Asthma Patients

Inclusion Criteria:

• Sign the ICF
• Age ≥ 12 years
• 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-745 test (see Appendix C) ≤ 3.0
• Current use of inhaled corticosteroid (beclomethasone dipropionate dose of up to 1000 µg), associated or not with long-term β2-adrenergic agents and breakthrough medication (salbutamol or equivalent)
• Initial FEV1 of at least 40% of the predicted normal value
• Serum cortisol assessment within normal values.

Exclusion Criteria:

• Use of oral or parenteral corticosteroid within the 3 months prior to study beginning
• Requirement of admission due to asthma within the 3 months prior to study beginning
• Presence of active smoking, defined as the use of cigarette, pipe, cigar or any form of smoking at any amount within the last 3 months
• Presence of severe co-morbidities, such as cardiovascular, renal, liver, neurological, neoplastic, hematological, infectious, dermatological, neurological, psychiatric or chronic respiratory disease other than asthma
• Recent (< 6 months) or predicted participation during this study in other clinical studies involving drugs of any nature or in studies of any form of intervention for treating asthma
• Intolerance or allergy to any of the components of the drugs assessed in the study
• Pregnancy or lactation
• Chronic use of β-blocker medications, per routine oral or intravenous route, or also as ophthalmic solutions