Status:
COMPLETED
A Study Comparative of Formoterol/Fluticasone Foraseq® and Fluticasone in Asthma Patients
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 impact of the study formulations on pulmonary function in persistent asthma carriers.
Eligibility Criteria
Inclusion
- Sign the ICF
- Age ≥ 12 years
- 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-745 test (see Appendix C) ≤ 3.0
- Current use of inhaled corticosteroid (beclomethasone dipropionate dose of up to 1000 µg), associated or not with long-term β2-adrenergic agents and breakthrough medication (salbutamol or equivalent)
- Initial FEV1 of at least 40% of the predicted normal value
- Serum cortisol assessment within normal values.
Exclusion
- Use of oral or parenteral corticosteroid within the 3 months prior to study beginning
- Requirement of admission due to asthma within the 3 months prior to study beginning
- Presence of active smoking, defined as the use of cigarette, pipe, cigar or any form of smoking at any amount within the last 3 months
- Presence of severe co-morbidities, such as cardiovascular, renal, liver, neurological, neoplastic, hematological, infectious, dermatological, neurological, psychiatric or chronic respiratory disease other than asthma
- Recent (\< 6 months) or predicted participation during this study in other clinical studies involving drugs of any nature or in studies of any form of intervention for treating asthma
- Intolerance or allergy to any of the components of the drugs assessed in the study
- Pregnancy or lactation
- Chronic use of β-blocker medications, per routine oral or intravenous route, or also as ophthalmic solutions
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
222 Patients enrolled
Trial Details
Trial ID
NCT01202084
Start Date
January 1 2012
End Date
November 1 2012
Last Update
June 18 2015
Active Locations (1)
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1
IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada
São Paulo, Brazil