Efficacy and Safety of Flamboyant 200/12 Association in the Treatment of Adults With Severe Asthma

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of Flamboyant 200/12 association in adults with asthma.

Official Title
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Multicenter, Randomized, Double-blind, Double-dummy, National, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Flamboyant 200/12 Association in the Treatment of Adults With Severe Asthma .

Conditions
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Asthma

Intervention / Treatment
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* Drug: Flamboyant 200/12
* Drug: Budesonide / Formoterol 400/12
* Other: Flamboyant 200/12 Placebo
* Other: Budesonide / Formoterol 400/12 Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms; Participants aged 18 years or more; Diagnosis of uncontrolled severe asthma; Participants with Forced expiratory volume in 1 second (FEV1) > 60% of predicted; Exclusion Criteria: Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants; Known hypersensitivity to the formula components used during the clinical trial; History of alcohol and/or substance abuse within 12 months prior to Screening Visit. Current smoking or smoking history equivalent to 10 pack years Participants with untreated oral candidiasis; Pulmonary disease history (e.g., chronic obstructive pulmonary disease [COPD], cystic fibrosis, bronchiectasis, tuberculosis); Participants with a history of acute asthma exacerbation, respiratory tract infection or hospitalization for asthma in the last 4 weeks; Known HIV-positive status or active hepatitis B or C virus test result Participants with current evidence or history of uncontrolled coronary artery disease, congestive heart failure, myocardial infarction or cardiac arrhythmia; Participants with a current medical history of cancer and/or cancer treatment in the last 5 years; Participants using medications that would have an effect on bronchospasm and / or lung function.

Ages Eligible for Study
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Minimum Age: 18 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FLAMBOYANT 200/12<br>The study is double-dummy. Thus, the participant must inhale 2 (two) capsules twice a day (12/12h), as follow: 1 Flamboyant 200/12 capsule 1 Budesonide/formoterol Placebo capsule. | Drug: Flamboyant 200/12<br>* Flamboyant 200/12 capsule<br>Other: Budesonide / Formoterol 400/12 Placebo<br>* Budesonide / Formoterol 400/12 Placebo capsule<br>|
| Active Comparator: Budesonide/formoterol 400/12<br>The study is double-dummy. Thus, the participant must inhale 2 (two) capsules twice a day (12/12h), as follow: 1 Budesonide/formoterol 400/12 capsule 1 Flamboyant 200/12 Placebo capsule. | Drug: Budesonide / Formoterol 400/12<br>* Budesonide / Formoterol 400/12 capsule<br>Other: Flamboyant 200/12 Placebo<br>* Flamboyant 200/12 Placebo capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Forced expiratory volume in 1 second (FEV1), obtained through espirometry. |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of adverse events recorded during the study. |  | 14 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma