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

EMS

Status and phase: Enrolling; Phase 3

Conditions: Asthma

Treatments: Drug: Flamboyant 200/12; Other: Budesonide / Formoterol 400/12 Placebo; Other: Flamboyant 200/12 Placebo; Drug: Budesonide / Formoterol 400/12

Study type: Interventional

Funder types: Industry

Identifiers

NCT04191447

EMS0319 - FLAMBOYANT200/12

Details and patient eligibility

About

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

Enrollment: 134 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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134 participants in 2 patient groups

FLAMBOYANT 200/12

Experimental group

Description:

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.

Treatment:

Other: Budesonide / Formoterol 400/12 Placebo

Drug: Flamboyant 200/12

Budesonide/formoterol 400/12

Active Comparator group

Description:

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.

Treatment:

Other: Flamboyant 200/12 Placebo

Drug: Budesonide / Formoterol 400/12