Conditions: Asthma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 552
Healthy volunteers: no

Brief 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.

Detailed description:
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.

Arms:
arm 1: formoterol and budesonide will be administered at the 12/400 µg dosage, twice a day for 12 weeks. arm 2: Foraseq will be administered at the 12/400 µg dosage, twice a da for 12 weeks. arm 3: Alenia will be administered at the 12/400 µg dosage, twice a da for 12 weeks.

Interventions: intervention 1: Formoterol/Budesonide intervention 2: Foraseq intervention 3: Alenia
Intervention descriptions: intervention 1: formoterol and budesonide will be administered at the 12/400 µg dosage, twice a da for 12 weeks. intervention 2: foraseq will be administered at the 12/400 µg dosage, twice a da for 12 weeks. intervention 3: Alenia will be administered at the 12/400 µg dosage, twice a da for 12 weeks.

Protocol document: