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

Phase 3

Completed

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Formoterol/Budesonide	Formoterol/Budesonide	formoterol and budesonide will be administered at the 12/400 µg dosage, twice a day for 12 weeks.
Alenia	Alenia	Alenia will be administered at the 12/400 µg dosage, twice a da for 12 weeks.
Foraseq	Foraseq	Foraseq will be administered at the 12/400 µg dosage, twice a da for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Forced Expiratory Volume in 1 Second (FEV1) at the Final Visit (FV)	12 weeks	The primary efficacy analysis was performed by evaluating non-inferiority of Eurofarma's device compared to Alenia® in relation to FEV1 (in liters) in FV in the PP population

Secondary Outcome Measures

Name	Time	Method
FEV1 (L) in VF in the ITT Population, to Assess the Difference Between the Three Groups	12 weeks	The mean FEV1 (L) in VF were compared between the three groups using the nonparametric Kruskal-Walllis test and the ITT population. A nonparametric test was used since the variable did not show normal distribution in the Foraseq® group.

Locations (5): Clinica de Alergia Martti Antila
🇧🇷
Sorocaba, SP, Brazil
Stelmach Pesquisa Clinica
🇧🇷
São Paulo, SP, Brazil
IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada
🇧🇷
São Paulo, SP, Brazil
Centro de Referencia em Enfermidades Respiratoria e Alergica
🇧🇷
Salvador, BA, Brazil
Hospital de Clinicas UFPR
🇧🇷
Curitiba, PR, Brazil