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

Multicenter, Randomized, Double-blind, Double-dummy, National, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Flamboyant 125/12 Association in the Treatment of Adults With Moderate Asthma .

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04191434

Enrollment

134

Registered

2019-12-09

Start date

2022-07-22

Completion date

2023-10-31

Last updated

2022-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Asthma

Brief summary

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

Interventions

DRUGFlamboyant 125/12

Flamboyant 125/12 capsule

DRUGBudesonide/formoterol 200/6

Budesonid/formoterol 200/6 capsule

OTHERFlamboyant 125/12 Placebo

Flamboyant 125/12 Placebo capsule

OTHERBudesonide/formoterol 200/6 placebo

Budesonid/formoterol 200/6 Placebo capsule

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Masking description

Double-blind and double-dummy

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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 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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
Incidence and severity of adverse events recorded during the study.	14 weeks

Countries

Brazil

Contacts

Primary ContactAlexandra Dumont Alves, MD

pesquisa.clinica@ncfarma.com.br+551938879851

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026