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

NCT01167010 | Completed Phase 3 Results DMC

• 1 other identifier: EF111
• Study Type: interventional
• Target: 552
• Locations: 1 country
• Sites: 5

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Forced Expiratory Volume in 1 Second (FEV1) at the Final Visit (FV)

  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

  12 weeks

Secondary Outcomes (1)

• FEV1 (L) in VF in the ITT Population, to Assess the Difference Between the Three Groups

  12 weeks

Study Arms (3)

Formoterol/Budesonide

EXPERIMENTAL

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

Drug: Formoterol/Budesonide

Foraseq

ACTIVE COMPARATOR

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

Drug: Foraseq

Alenia

ACTIVE COMPARATOR

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

Drug: Alenia

Interventions

Formoterol/Budesonide DRUG

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

Formoterol/Budesonide

Foraseq DRUG

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

Also known as: Formoterol/Budesonide

Foraseq

Alenia DRUG

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

Also known as: Formoterol/Budesonide

Alenia

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eurofarma Laboratorios S.A.: lead

Study Sites (5)

Centro de Referencia em Enfermidades Respiratoria e Alergica

Salvador, Estado de Bahia, Brazil

Location

Hospital de Clinicas UFPR

Curitiba, Paraná, Brazil

Location

IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada

São Paulo, São Paulo, Brazil

Location

Stelmach Pesquisa Clinica

São Paulo, São Paulo, Brazil

Location

Clinica de Alergia Martti Antila

Sorocaba, São Paulo, Brazil

Location

MeSH Terms

Conditions

Asthma

Interventions

Formoterol Fumarate; Budesonide

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Sandra Rodrigues (Clinical Research)
• Organization: Eurofarma Laboratórios S.A

sandra.rodrigues@eurofarma.com.br

1150908600

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2010
• First Posted: July 21, 2010
• Study Start: April 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: February 1, 2012
• Last Updated: May 1, 2025
• Results First Posted: May 1, 2025

Record last verified: 2025-03

Locations

BR (5)