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

NCT ID: NCT01167010

Last Updated: 2025-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 552 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2012-02-29

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Formoterol/Budesonide

formoterol and budesonide will be administered at the 12/400 µg dosage, twice a day for 12 weeks.

Group Type: EXPERIMENTAL

Formoterol/Budesonide

Intervention Type: DRUG

formoterol and budesonide will be administered at the 12/400 µg dosage, twice a da for 12 weeks.

Foraseq

Foraseq will be administered at the 12/400 µg dosage, twice a da for 12 weeks.

Group Type: ACTIVE_COMPARATOR

Foraseq

Intervention Type: DRUG

foraseq will be administered at the 12/400 µg dosage, twice a da for 12 weeks.

Alenia

Alenia will be administered at the 12/400 µg dosage, twice a da for 12 weeks.

Group Type: ACTIVE_COMPARATOR

Alenia

Intervention Type: DRUG

Alenia will be administered at the 12/400 µg dosage, twice a da for 12 weeks.

Interventions

Formoterol/Budesonide

formoterol and budesonide will be administered at the 12/400 µg dosage, twice a da for 12 weeks.

Intervention Type: DRUG

Foraseq

foraseq will be administered at the 12/400 µg dosage, twice a da for 12 weeks.

Intervention Type: DRUG

Alenia

Alenia will be administered at the 12/400 µg dosage, twice a da for 12 weeks.

Intervention Type: DRUG

Other Intervention Names

Formoterol/Budesonide; Formoterol/Budesonide

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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eurofarma Laboratorios S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centro de Referencia em Enfermidades Respiratoria e Alergica

Salvador, Estado de Bahia, Brazil

Hospital de Clinicas UFPR

Curitiba, Paraná, Brazil

IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada

São Paulo, São Paulo, Brazil

Stelmach Pesquisa Clinica

São Paulo, São Paulo, Brazil

Clinica de Alergia Martti Antila

Sorocaba, São Paulo, Brazil

Countries

Brazil

Other Identifiers

EF111

Identifier Type: -

Identifier Source: org_study_id