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

Asthma Clinical Trial

Official title:

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 .

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04191447
• Other study ID #: EMS0319 - FLAMBOYANT200/12
• Status: Recruiting
• Phase: Phase 3
• Start date: July 22, 2022
• Est. completion date: October 2023

Study information

• Verified date: July 2022
• Source: EMS
• Contact: Alexandra Dumont Alves, MD
• Phone: +551938879851
• Email: pesquisa.clinica[@]ncfarma.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 134
• Est. completion date: October 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Flamboyant 200/12
Flamboyant 200/12 capsule
• Budesonide / Formoterol 400/12
Budesonide / Formoterol 400/12 capsule

Other:
• Flamboyant 200/12 Placebo
Flamboyant 200/12 Placebo capsule
• Budesonide / Formoterol 400/12 Placebo
Budesonide / Formoterol 400/12 Placebo capsule

Locations

Country	Name	City	State
Brazil	IMC Tatuí	Tatuí	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
EMS

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Forced expiratory volume in 1 second (FEV1), obtained through espirometry.		12 weeks
Secondary	Incidence and severity of adverse events recorded during the study.		14 weeks