Status:
COMPLETED
A Non- Inferiority Comparative Study Between Seretide® and Salmeterol/Fluticasone Eurofarma in Patients with Asthma
Lead Sponsor:
Eurofarma Laboratorios S.A.
Conditions:
Asthma
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
The primary objective will be to compare the formulations regarding their impact on the pulmonary function of persistent asthma patients and the secondary objective will be the clinical control of the...
Detailed Description
The primary objective will be to compare the formulations regarding their impact on the pulmonary function of persistent asthma patients and the secondary objective will be the clinical control of the...
Eligibility Criteria
Inclusion
- Sign the ICF
- ≥ 12 years old
- Have a persistent asthma diagnosis, as per GINA classification,18 with symptoms for at least 6 months and clinically stable for at least 1 month with the ACQ-7 test (please see Appendix C) ≤ 3.0
- Current use of inhaled corticosteroid (up to 1000 µg of beclomethasone dipropionate) whether combined or not with long-term β2-adrenergics and relief medication (salbutamol or equivalent)
- Initial FEV1 of at least 40% of the normal value expected
- Blood cortisol evaluation within the normal limits.
Exclusion
- Use of oral or parenteral corticosteroid within the last 3 previous months to the study
- Hospitalization needed due to asthma within the last 3 previous months to 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 severe co-morbidities, such as cardiovascular, renal, liver, neurological, neoplastic, hematological, infectious, dermatological, neurological or psychiatric disease or chronic respiratory disease other than asthma
- Recent (\<6 months) or expected participation during this study in other clinical trials involving drugs of any nature or in studies consisting of any - 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.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
334 Patients enrolled
Trial Details
Trial ID
NCT01202097
Start Date
August 1 2011
End Date
May 1 2012
Last Update
March 31 2025
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital de Clinicas UFPR
Curitiba, PR, Brazil
2
Centro de Referencia em Enfermidades Respiratoria e Alergica
Salvador, BA, Brazil
3
Centro de Estudos de Pneumologia FMABC
São Paulo, Brazil
4
IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada
São Paulo, Brazil