A Non-inferiority, Comparative Study Between Foraseq®, Eurofarma´s Formoterol/Budesonide and Alenia® in Asthma

Study Overview
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Brief Summary
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The primary objective will be to compare the Eurofarma and Alenia formulations regarding their impact on the pulmonary function of mild to moderate persistent asthma patients and the secondary objective will be to compare the three study formulations regarding the clinical control of the symptoms and the patients' compliance to the treatment.

Official Title
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A Phase III, Randomized, Non-inferiority, Open-label, Comparative Study Between Foraseq® Inhalation Capsules, Eurofarma's Single Formoterol / Budesonide Inhalation Capsule and Single Alenia® Inhalation Capsule in Asthmatic Patients

Conditions
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Asthma

Intervention / Treatment
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* Drug: Formoterol/Budesonide
* Drug: Foraseq
* Drug: Alenia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sign the ICF; ≥ 12 years old; Have a diagnosis of mild to moderate 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-7 test <3,0; Current use of inhaled corticosteroid (equivalent to 1000 µg of beclomethasone dipropionate) whether associated or not with long-term β2 adrenergics and relief medication (salbutamol or equivalent); Initial FEV1 of at least 50% of the normal value expected; Serum cortisol evaluation within the normal limits Exclusion Criteria: Use of oral or parenteral corticosteroid within the last 3 months before the study; Hospitalization needed due to asthma within the last 3 months before 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 serious co-morbidities, such as cardiovascular, renal, liver, neurological, neoplastic, hematological, infectious, dermatologic, neurological, or psychiatric disease, or chronic respiratory disease other than asthma; Recent participation (<6 months) or expected participation in other clinical trials involving drug products of any nature or in studies consisting of any form of intervention for the treatment of asthma; 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: Formoterol/Budesonide<br>formoterol and budesonide will be administered at the 12/400 µg dosage, twice a day for 12 weeks. | Drug: Formoterol/Budesonide<br>* formoterol and budesonide will be administered at the 12/400 µg dosage, twice a da for 12 weeks.<br>|
| Active Comparator: Foraseq<br>Foraseq will be administered at the 12/400 µg dosage, twice a da for 12 weeks. | Drug: Foraseq<br>* foraseq will be administered at the 12/400 µg dosage, twice a da for 12 weeks.<br>|
| Active Comparator: Alenia<br>Alenia will be administered at the 12/400 µg dosage, twice a da for 12 weeks. | Drug: Alenia<br>* Alenia will be administered at the 12/400 µg dosage, twice a da for 12 weeks.<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 (FV) |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| asthma control score in the Asthma Control Questionnaire-7 (ACQ-7) |  | 4 months |