A Study Comparative of Formoterol/Fluticasone Foraseq® and Fluticasone in Asthma Patients
Phase 3
Completed
- Conditions
- Asthma
- Interventions
- Registration Number
- NCT01202084
- Lead Sponsor
- Eurofarma Laboratorios S.A.
- Brief Summary
The primary objective will be to compare the impact of the study formulations on pulmonary function in persistent asthma carriers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 222
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Formoterol/Fluticasone Eurofarma Formoterol/Fluticasone formoterol + fluticasone (12/250 mcg) twice a day per 12 weeks Foraseq® Foraseq® formoterol + budedonide (12/400 mcg) twice a day per 12 weeks Fluticasone Fluticasone fluticasone (500 mcg) twice a day per 12 weeks
- Primary Outcome Measures
Name Time Method Forced expiratory volume in 1 second (FEV1) at final visit. 12 weeks
- Secondary Outcome Measures
Name Time Method Peak expiratory flow (PEF) 12 weeks
Trial Locations
- Locations (1)
IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada
🇧🇷São Paulo, Brazil