A Multicenter, Randomized, Parallel, Two-Period, Non-Inferiority Study of EurofarmavsAlenia in Asthma and COPD Treatment

Study Overview
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Brief Summary
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A phase III study, multicenter, randomized, parallel, open, two-period, comparative non-inferiority of Eurofarma versus Alenia® in the treatment of moderate to severe persistent asthma with and without obstructive pulmonary disease (COPD). ⚠️study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).

Detailed Description
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In the first study period (Period 1), patients with moderate to severe persistent asthma according to GINA criteria, with or without COPD, will be randomized at a 1: 1 ratio to receive formoterol 12mcg / budesonide 400mcg Eurofarma or Alenia® 12mcg / 400mcg during 12 weeks Participants who maintain asthma control at the end of this treatment period (no more than one exacerbation during this period) will be included in Period 2, in which the dose of each investigational product will be reduced (step-down), and the patients will receive formoterol 6mcg / budesonide 200mcg Eurofarma or Alenia® 6mcg / 200mcg, respectively, for an additional 12 weeks. The primary non-inferiority assessment will be performed at the end of 24 weeks of treatment, with intermediate assessment at the end of week 12. The study will be conducted in an open label since the devices for inhalation of products have different aspects, making it impossible to blind the treatments of the study. The primary efficacy variable (forced expiratory volume in one second [FEV1]) minimizes the potential bias arising from the open label of the study. ⚠️study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).

Official Title
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A Randomized, Parallel-Group, Open, Two-Period, Comparative Non-Inferiority Study of Eurofarma's Formoterol/Budesonide vs Alenia in the Treatment of Moderate to Severe Persistent Asthma With and Without Chronic Obstructive Pulmonary COPD

Conditions
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Asthma Copd

Intervention / Treatment
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* Drug: Alenia® 12mcg + 400mcg / Alenia® 6mcg + 200mcg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 12 years Presence of moderate to severe persistent asthma according to Global Initiative for Asthma (GINA) 1 criteria for at least 1 year, clinically stable (controlled) for at least 30 days. Exclusion Criteria: Occurrence of asthma exacerbation within 30 days prior to initiation of study treatment. Presence of acute or chronic symptomatic airway infection.

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
Interventional Model Description: In the first study period (Period 1), patients with moderate to severe persistent asthma according to GINA criteria, with or without COPD, will be randomized at a 1: 1 ratio to receive formoterol 12mcg / budesonide 400mcg Eurofarma or Alenia® 12mcg / 400mcg during 12 weeks Participants who maintain asthma control at the end of this treatment period (no more than one exacerbation during this period) will be included in Period 2, in which the dose of each investigational product will be reduced (step-down), and the patients will receive formoterol 6mcg / budesonide 200mcg Eurofarma or Alenia® 6mcg / 200mcg, respectively, for an additional 12 weeks. The primary non-inferiority assessment will be performed at the end of 24 weeks of treatment, with intermediate assessment at the end of week 12.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Formoterol + budesonide Eurofarma (12/400mcg e 6/200mcg)<br>Formoterol 12mcg + budesonide 400mcg / Formoterol 6mcg + budesonide 200mcg | Drug: Alenia® 12mcg + 400mcg / Alenia® 6mcg + 200mcg<br>* one inhalation, twice daily<br>* Other names: fumarato de formoterol di-hidratado 12mcg + budesonida 400mcg/fumarato de formoterol di-hidratado 62mcg + budesonida 200mcg;|
| Active Comparator: Alenia® (12/400mcg e 6/200mcg)<br>Alenia® 12mcg + 400mcg / Alenia® 6mcg + 200mcg | Drug: Alenia® 12mcg + 400mcg / Alenia® 6mcg + 200mcg<br>* one inhalation, twice daily<br>* Other names: fumarato de formoterol di-hidratado 12mcg + budesonida 400mcg/fumarato de formoterol di-hidratado 62mcg + budesonida 200mcg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1 | Average change from baseline in pre-dose Forced Expiratory Volume in one second | 24 weeks |