A Non- Inferiority Comparative Study Between Seretide® and Salmeterol/Fluticasone Eurofarma in Patients With Asthma

Study Overview
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Brief Summary
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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 disease's symptoms.

Detailed Description
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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 disease's symptoms. Primary endpoint: Forced expiratory volume in 1 second (FEV1) at the final visit. Secondary endpoints: Expiratory Flow Peak (EFP), symptoms score, FEV1 throughout the study, use of rescue medication, compliance with inhaler use, inhaler acceptance and preference, and frequency of the observed adverse events.

Official Title
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A PHASE III, RANDOMIZED, OPEN-LABEL, NON-INFERIORITY COMPARATIVE STUDY BETWEEN SERETIDE® 50/250 µG AND SALMETEROL/FLUTICASONE SINGLE INHALATION CAPSULE 50/250 µG EUROFARMA IN PATIENTS WITH ASTHMA

Conditions
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Asthma

Intervention / Treatment
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* Drug: Salmeterol/Fluticasone
* Drug: Seretide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

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: Salmeterol/Fluticasone<br> | Drug: Salmeterol/Fluticasone<br> <br> |
| Active Comparator: Seretide<br> | Drug: Seretide<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 the final visit. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expiratory Flow Peak (EFP) |  |  |