Non-Inferiority,Combination Formoterol/FluticasonexAlenia®Formoterol/Budesonide for Asthma in Brazil
Key facts
- Who runs it
- Eurofarma Laboratorios S.A.
- Where
- Brazil1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Withdrawn
- Phase
- Phase 3
- Started
- Jun 2026
- Expected to end
- Nov 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Administration of investigation drug
- Administration of comparator
- Record updated
- 18 December 2025
- Why it stopped
- Strategic change in development priorities
Who can take part
- Age
- 12 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- Patients of both sexes who meet all of the following criteria will be included in the study:
- Signature of the Informed Consent Term (ICF) for people over 18 years and, when applicable, signature of the Informed Assent Form (IAF) by the participant under 18 years of age and the ICF by the representative before carrying out any study procedure
- Age ≥ 12 years
- History of recurrent symptoms suggestive of asthma (cough, wheezing, shortness of breath, and/or chest tightness)
- Previous medical diagnosis of asthma
Who cannot take part
- Occurrence of moderate to serious asthma exacerbation within 90 days prior to initiation of study treatment
- Use of long-acting anticholinergic drug (LAMA) in the last six (06) months
- Presence of acute or chronic symptomatic respiratory tract infection
- Patients who meet at least one of the following criteria will be excluded from the study:
- Body mass index (BMI) ≥ 38 kg/m2
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
Eurofarma Laboratórios S.A. markets a FDC containing formoterol 12 mcg/fluticasone 250 mcg, in a single capsule for inhalation (Lugano®; reference product). The product is indicated for the treatment of asthma in patients aged ≥ 12 years. The company seeks to register a product with lower concentrations of mono-drugs (6 mcg and 125 mcg, respectively) to enable the dosage step up and step down treatment strategies advocated by the Global Initiative for Asthma for the inhaled maintenance treatment of asthma (GINA, 2022 ) with these combinations.
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This Phase 3 study will be carried out for demonstrating the non-inferiority of the investigational drug (FDC of formoterol 6 mcg/fluticasone 125 mcg) compared to the FDC of formoterol 6 mcg/budesonide 200 mcg (Alenia® - Aché Laboratórios Farmacêuticos S.A.) in the maintenance treatment of asthma, allowing its registration as a new concentration of the drug already registered by the company.
The 2 groups in the trial
- Formoterol 6 mcg/fluticasone 125 mcgTreatment being tested
Formoterol 6 mcg/fluticasone 125 mcg Eurofarma.
Treatment: Administration of investigation drug
- Alenia® 6 mcg/200 mcgExisting treatment, for comparison
Treatment: Administration of comparator
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Phase 3, Multicenter, Randomized, Parallel-Group, Open-Label, Comparative Non-Inferiority Fixed-Dose Combination Formoterol 6 mcg/Fluticasone 125 mcg Versus Alenia® (Formoterol 6 mcg/Budesonide 200 mcg) in the Treatment of Moderate Asthma
- Record updated
- 18 December 2025