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

Asthma Clinical Trial

— UNIK  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01167010
• Other study ID #: EF111
• Status: Completed
• Phase: Phase 3
• First received: July 20, 2010
• Last updated: May 4, 2012
• Start date: April 2011
• Est. completion date: February 2012

Study information

• Verified date: May 2011
• Source: Eurofarma Laboratorios S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics CommitteeBrazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 552
• Est. completion date: February 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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 ß2 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 ß-blockers orally or intravenously, including ophthalmic solutions.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Formoterol/Budesonide
formoterol and budesonide will be administered at the 12/400 µg dosage, twice a da for 12 weeks.
• Foraseq
foraseq will be administered at the 12/400 µg dosage, twice a da for 12 weeks.
• Alenia
Alenia will be administered at the 12/400 µg dosage, twice a da for 12 weeks.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Eurofarma Laboratorios S.A.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	forced expiratory volume in 1 second (FEV1) at the final visit (FV)		4 months	No
Secondary	asthma control score in the Asthma Control Questionnaire-7 (ACQ-7)		4 months	Yes