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

This study has been completed.
Sponsor:
Information provided by:
Eurofarma Laboratorios S.A.
ClinicalTrials.gov Identifier:
NCT01167010
First received: July 20, 2010
Last updated: May 4, 2012
Last verified: May 2011
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: Formoterol/Budesonide
Drug: Foraseq
Drug: Alenia
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Eurofarma Laboratorios S.A.:

Primary Outcome Measures:
  • forced expiratory volume in 1 second (FEV1) at the final visit (FV) [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • asthma control score in the Asthma Control Questionnaire-7 (ACQ-7) [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 552
Study Start Date: April 2011
Study Completion Date: February 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Formoterol/Budesonide
formoterol and budesonide will be administered at the 12/400 µg dosage, twice a day for 12 weeks.
Drug: Formoterol/Budesonide
formoterol and budesonide will be administered at the 12/400 µg dosage, twice a da for 12 weeks.
Active Comparator: Foraseq
Foraseq will be administered at the 12/400 µg dosage, twice a da for 12 weeks.
Drug: Foraseq
foraseq will be administered at the 12/400 µg dosage, twice a da for 12 weeks.
Active Comparator: Alenia
Alenia will be administered at the 12/400 µg dosage, twice a da for 12 weeks.
Drug: Alenia
Alenia will be administered at the 12/400 µg dosage, twice a da for 12 weeks.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01167010

Locations
Brazil
Centro de Referencia em Enfermidades Respiratoria e Alergica
Salvador, BA, Brazil
Hospital de Clinicas UFPR
Curitiba, PR, Brazil
Clinica de Alergia Martti Antila
Sorocaba, SP, Brazil
IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada
São Paulo, SP, Brazil
Stelmach Pesquisa Clinica
São Paulo, SP, Brazil
Sponsors and Collaborators
Eurofarma Laboratorios S.A.
  More Information

No publications provided

Responsible Party: Ana Lúcia Koff Milan, Eurofarma Laboratorios Ltda
ClinicalTrials.gov Identifier: NCT01167010     History of Changes
Other Study ID Numbers: EF111
Study First Received: July 20, 2010
Last Updated: May 4, 2012
Health Authority: Brazil: Ethics Committee
Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Formoterol
Symbicort
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 19, 2014