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

Phase 3

• Conditions: Asthma
• Interventions: Drug: Flamboyant 200/12; Drug: Budesonide / Formoterol 400/12; Other: Budesonide / Formoterol 400/12 Placebo; Other: Flamboyant 200/12 Placebo

• Registration Number: NCT04191447
• Lead Sponsor: EMS

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-05
• Study First Submitted QC: 2019-12-05
• Study First Posted: 2019-12-09
• Status Verified: 2022-07
• Study Start: 2022-07-22
• Last Update Submitted: 2022-07-25
• Last Update Posted: 2022-07-27
• Primary Completion: 2023-07
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 134

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FLAMBOYANT 200/12	Flamboyant 200/12	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.
FLAMBOYANT 200/12	Budesonide / Formoterol 400/12 Placebo	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.
Budesonide/formoterol 400/12	Budesonide / Formoterol 400/12	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.
Budesonide/formoterol 400/12	Flamboyant 200/12 Placebo	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline in Forced expiratory volume in 1 second (FEV1), obtained through espirometry.	12 weeks

Secondary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events recorded during the study.	14 weeks

Trial Locations

Locations (1)

IMC Tatuí; 🇧🇷 Tatuí, São Paulo, Brazil