Efficacy and Safety of Flamboyant 125/12 Association in the Treatment of Adults With Moderate Asthma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-22

Study Completion Date

2023-10-31

Brief Summary

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The purpose of this study is to evaluate the efficacy and safety of Flamboyant 125/12 association in adults with asthma.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Double-blind and double-dummy

Study Groups

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FLAMBOYANT 125/12

The study is double-dummy. Thus, the participant must inhale 2 (two) capsules twice a day (12/12h), as follow:

1 Flamboyant 125/12 capsule

1 Budesonide/formoterol 200/6 Placebo capsule.

Group Type EXPERIMENTAL

Flamboyant 125/12

Intervention Type DRUG

Flamboyant 125/12 capsule

Budesonide/formoterol 200/6 placebo

Intervention Type OTHER

Budesonid/formoterol 200/6 Placebo capsule

Budesonide/formoterol 200/6

The study is double-dummy. Thus, the participant must inhale 2 (two) capsules twice a day (12/12h), as follow:

1 Budesonide/formoterol 200/6 capsule

1 Flamboyant 125/12 Placebo capsule.

Group Type ACTIVE_COMPARATOR

Budesonide/formoterol 200/6

Intervention Type DRUG

Budesonid/formoterol 200/6 capsule

Flamboyant 125/12 Placebo

Intervention Type OTHER

Flamboyant 125/12 Placebo capsule

Interventions

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Flamboyant 125/12

Flamboyant 125/12 capsule

Intervention Type DRUG

Budesonide/formoterol 200/6

Budesonid/formoterol 200/6 capsule

Intervention Type DRUG

Flamboyant 125/12 Placebo

Flamboyant 125/12 Placebo capsule

Intervention Type OTHER

Budesonide/formoterol 200/6 placebo

Budesonid/formoterol 200/6 Placebo capsule

Intervention Type OTHER

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 moderate 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 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No