Back to resultsA Non-inferiority, Comparative Study Between Foraseq®, Eurofarma´s Formoterol/Budesonide and Alenia® in Asthma (UNIK)
Primary Purpose
Asthma
Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Formoterol/Budesonide
Foraseq
Alenia
Sponsored by
About this trial
This is an interventional treatment trial for Asthma
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.
Sites / Locations
- Centro de Referencia em Enfermidades Respiratoria e Alergica
- Hospital de Clinicas UFPR
- Clinica de Alergia Martti Antila
- IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada
- Stelmach Pesquisa Clinica
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Formoterol/Budesonide
Foraseq
Alenia
Arm Description
formoterol and budesonide will be administered at the 12/400 µg dosage, twice a day for 12 weeks.
Foraseq will be administered at the 12/400 µg dosage, twice a da for 12 weeks.
Alenia will be administered at the 12/400 µg dosage, twice a da for 12 weeks.
Outcomes
Primary Outcome Measures
forced expiratory volume in 1 second (FEV1) at the final visit (FV)
Secondary Outcome Measures
asthma control score in the Asthma Control Questionnaire-7 (ACQ-7)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01167010
Brief Title
A Non-inferiority, Comparative Study Between Foraseq®, Eurofarma´s Formoterol/Budesonide and Alenia® in Asthma
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Eurofarma Laboratorios S.A.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
552 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Formoterol/Budesonide
Arm Type
Experimental
Arm Description
formoterol and budesonide will be administered at the 12/400 µg dosage, twice a day for 12 weeks.
Arm Title
Foraseq
Arm Type
Active Comparator
Arm Description
Foraseq will be administered at the 12/400 µg dosage, twice a da for 12 weeks.
Arm Title
Alenia
Arm Type
Active Comparator
Arm Description
Alenia will be administered at the 12/400 µg dosage, twice a da for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Formoterol/Budesonide
Intervention Description
formoterol and budesonide will be administered at the 12/400 µg dosage, twice a da for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Foraseq
Intervention Description
foraseq will be administered at the 12/400 µg dosage, twice a da for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Alenia
Intervention Description
Alenia will be administered at the 12/400 µg dosage, twice a da for 12 weeks.
Primary Outcome Measure Information:
Title
forced expiratory volume in 1 second (FEV1) at the final visit (FV)
Time Frame
4 months
Secondary Outcome Measure Information:
Title
asthma control score in the Asthma Control Questionnaire-7 (ACQ-7)
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Centro de Referencia em Enfermidades Respiratoria e Alergica
City
Salvador
State/Province
BA
Country
Brazil
Facility Name
Hospital de Clinicas UFPR
City
Curitiba
State/Province
PR
Country
Brazil
Facility Name
Clinica de Alergia Martti Antila
City
Sorocaba
State/Province
SP
Country
Brazil
Facility Name
IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada
City
São Paulo
State/Province
SP
Country
Brazil
Facility Name
Stelmach Pesquisa Clinica
City
São Paulo
State/Province
SP
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
A Non-inferiority, Comparative Study Between Foraseq®, Eurofarma´s Formoterol/Budesonide and Alenia® in Asthma
We'll reach out to this number within 24 hrs