Clinical trial NCT01167010: A Non-inferiority, Comparative Study Between Foraseq®, Eurofarma´s Formoterol/Budesonide and Alenia® in Asthma
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: Eurofarma Laboratorios S.A.
Sponsor class: INDUSTRY
First posted: 2010-07-21
Enrollment: 552
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: Forced Expiratory Volume in 1 Second (FEV1) at the Final Visit (FV)
timeFrame: 12 weeks
Secondary outcomes:
measure: FEV1 (L) in VF in the ITT Population, to Assess the Difference Between the Three Groups
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Centro de Referencia em Enfermidades Respiratoria e Alergica
state: BA
city: Curitiba
country: Brazil
facility: Hospital de Clinicas UFPR
state: PR
city: Sorocaba
country: Brazil
facility: Clinica de Alergia Martti Antila
state: SP
city: São Paulo
country: Brazil
facility: IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada
state: SP
city: São Paulo
country: Brazil
facility: Stelmach Pesquisa Clinica
state: SP
Study officials:
References: