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

Eurofarma

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Formoterol/Budesonide; Drug: Alenia; Drug: Foraseq

Study type: Interventional

Funder types: Industry

Identifiers

NCT01167010

EF111

Details and patient eligibility

About

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.

Enrollment: 552 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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552 participants in 3 patient groups

Formoterol/Budesonide

Experimental group

Description:

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

Treatment:

Drug: Formoterol/Budesonide

Foraseq

Active Comparator group

Description:

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

Treatment:

Drug: Foraseq

Alenia

Active Comparator group

Description:

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

Treatment:

Drug: Alenia