Phase 3
N=552
A Non-inferiority, Comparative Study Between Foraseq®, Eurofarma´s Formoterol/Budesonide and Alenia® in Asthma
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT01167010 ↗Enrolled (actual)
552
Serious AEs
0.2%
Results posted
May 2025
Primary outcome: Primary: Forced Expiratory Volume in 1 Second (FEV1) at the Final Visit (FV) — 2.53; 2.51 Liter
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Formoterol/Budesonide (Drug); Foraseq (Drug); Alenia (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Eurofarma Laboratorios S.A.
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Forced Expiratory Volume in 1 Second (FEV1) at the Final Visit (FV) |
2.53; 2.51 | — |
| SECONDARY FEV1 (L) in VF in the ITT Population, to Assess the Difference Between the Three Groups |
2.49; 2.52; 2.46 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01167010). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.