A Study Comparative of Formoterol/Fluticasone Foraseq® and Fluticasone in Asthma Patients

Study Overview
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Brief Summary
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The primary objective will be to compare the impact of the study formulations on pulmonary function in persistent asthma carriers.

Official Title
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A Phase III, Randomized, Open-label, Non-inferiority Study Comparative of Formoterol/Fluticasone Eurofarma 12/250 µg, Foraseq® 12/400 µg and Fluticasone 500 µg in Asthma Patients

Conditions
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Asthma

Intervention / Treatment
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* Drug: Formoterol/Fluticasone
* Drug: Foraseq®
* Drug: Fluticasone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Formoterol/Fluticasone Eurofarma<br>formoterol + fluticasone (12/250 mcg) twice a day per 12 weeks | Drug: Formoterol/Fluticasone<br> <br> |
| Active Comparator: Foraseq®<br>formoterol + budedonide (12/400 mcg) twice a day per 12 weeks | Drug: Foraseq®<br> <br> |
| Active Comparator: Fluticasone<br>fluticasone (500 mcg) twice a day per 12 weeks | Drug: Fluticasone<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced expiratory volume in 1 second (FEV1) at final visit. |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak expiratory flow (PEF) |  | 12 weeks |