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

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective will be to compare the Eurofarma and Alenia formulations regarding their impact on the pulmonary function of mild to moderate persistent asthma patients and the secondary objective will be to compare the three study formulations regarding the clinical control of the symptoms and the patients' compliance to the treatment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eurofarma Laboratorios S.A.
• Treatments: Budesonide; Formoterol Fumarate

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.