A Comparative Study Between Foraseq And Formoterol/Budesonide Inhalation Capsules in Patients With Asthma

Study Overview
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Brief Summary
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This study primary objective is to compare the impact of two products containing budesonide and formoterol as individual capsules with inhalation powder for the pulmonary function of subjects with persistent asthma.

Detailed Description
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This study primary objective is to compare the impact of two products containing budesonide and formoterol as individual capsules with inhalation powder for the pulmonary function of subjects with persistent asthma. This is a non-inferiority study, which hypothesis is that there is no difference on the pulmonary function measure between the groups studied at its end. Therefore, the study primary endpoint will be the forced expiratory volume in 1 second (FEV1) at the final visit (FV) at each study arm. This study secondary objective is to compare the impact on the clinical control of two products containing budesonide and formoterol as individual capsules with inhalation powder in subjects with persistent asthma. The secondary endpoints considered for this study are: Score of asthma control questionnaire (ACQ-7) 34 at the end of the study ; Peak of expiratory flow (PEF) throughout the study; Symptoms score at the end of the study; FEV1 throughout the study; Treatment safety, including serum cortisol dosage; Frequency of observed adverse events. Some eligibility criteria: Current use of inhaled corticosteroids (equivalent to beclometasone dipropionate 1000µg) associated or not to long-acting β2-adrenergics and relief medication (salbutamol or equivalent); Diagnosis of mild to moderate persistent asthma, as per the ARIA classification, 35 with symptoms for at least 6 months, clinically stable for at least 1 month with ACQ-7 test34 (see Attachment D) < 3.0;

Official Title
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A Phase III, Randomized, Open-Label, Non-Inferiority Comparative Study Between Foraseq Inhalation Capsules 12/200 µg And Formoterol/ Budesonide Inhalation Capsules 12/200 µg Eurofarma In Patients With Asthma

Conditions
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ASTHMA

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sign ICF (see Attachment A); Age ≥12 years old Diagnosis of mild to moderate persistent asthma, as per the ARIA classification, 35 with symptoms for at least 6 months, clinically stable for at least 1 month with ACQ-7 test34 (see Attachment D) < 3.0; Current use of inhaled corticosteroids (equivalent to beclometasone dipropionate 1000µg) associated or not to long-acting β2-adrenergics and relief medication (salbutamol or equivalent); Initial FEV1 of at least 50% of the normal value estimated. Serum cortisol evaluation within the normal values Exclusion Criteria: Use of oral or parenteral corticosteroids within the last 3 months; Need of hospitalization due to asthma within the last 3 months; Active tabagism, defined as the use of cigarettes, pipe, cigar or any other type in any amount within the last 3 months; Severe co-morbidity, such as cardiovascular, renal, liver, neurologic, neoplastic, blood, infectious, dermatologic, neurologic, psychiatric or chronic respiratory diseases, other than asthma; Recent participation (<6 months) or planned participation, during this study, on other clinical trials involving drugs of any nature or under studies of any type of intervention for the asthma treatment; Intolerance or allergy to any of the compounds of the drugs evaluated on the study; Pregnancy or lactation; Chronic use of routine oral or intravenous β-blocker drugs, even 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> | Drug: Formoterol/Budesonide<br>* formoterol will be administered at the 12 µg dosage, twice a day, and budesonide will be administered at the 200 µg dose, also twice a day for 12 weeks.<br>|
| Active Comparator: Foraseq<br> | Drug: Foraseq<br>* formoterol will be administered at the 12 µg dosage, twice a day, and budesonide will be administered at the 200 µg dose, also twice a day for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The study primary endpoint will be the forced expiratory volume in 1 second (FEV1) at the final visit (FV) at each study arm. |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Only one Score of asthma control questionnaire (ACQ-7) 34 at the end of the study. |  | 4 months |