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

April 29, 2025 updated by: Eurofarma Laboratorios S.A.

A Phase III, Randomized, Non-inferiority, Open-label, Comparative Study Between Foraseq® Inhalation Capsules, Eurofarma's Single Formoterol / Budesonide Inhalation Capsule and Single Alenia® Inhalation Capsule in Asthmatic Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

552

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Formoterol/Budesonide
formoterol and budesonide will be administered at the 12/400 µg dosage, twice a day for 12 weeks.
Drug: Formoterol/Budesonide
formoterol and budesonide will be administered at the 12/400 µg dosage, twice a da for 12 weeks.
Active Comparator: Foraseq
Foraseq will be administered at the 12/400 µg dosage, twice a da for 12 weeks.
Drug: Foraseq
foraseq will be administered at the 12/400 µg dosage, twice a da for 12 weeks.
Other Names:
  • Formoterol/Budesonide
Active Comparator: Alenia
Alenia will be administered at the 12/400 µg dosage, twice a da for 12 weeks.
Drug: Alenia
Alenia will be administered at the 12/400 µg dosage, twice a da for 12 weeks.
Other Names:
  • Formoterol/Budesonide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Forced Expiratory Volume in 1 Second (FEV1) at the Final Visit (FV)
Time Frame: 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
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FEV1 (L) in VF in the ITT Population, to Assess the Difference Between the Three Groups
Time Frame: 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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eurofarma Laboratorios S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

July 20, 2010

First Submitted That Met QC Criteria

July 20, 2010

First Posted (Estimated)

July 21, 2010

Study Record Updates

Last Update Posted (Actual)

May 1, 2025

Last Update Submitted That Met QC Criteria

April 29, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EF111

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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