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

NCT04191447 | Unknown Phase 3 DMC

• 1 other identifier: EMS0319 - FLAMBOYANT200/12
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Asthma

Keywords

Asthma

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Forced expiratory volume in 1 second (FEV1), obtained through espirometry.

  12 weeks

Secondary Outcomes (1)

• Incidence and severity of adverse events recorded during the study.

  14 weeks

Study Arms (2)

FLAMBOYANT 200/12

EXPERIMENTAL

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.

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

Budesonide/formoterol 400/12

ACTIVE COMPARATOR

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.

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

Interventions

Flamboyant 200/12 DRUG

Flamboyant 200/12 capsule

FLAMBOYANT 200/12

Budesonide / Formoterol 400/12 DRUG

Budesonide / Formoterol 400/12 capsule

Budesonide/formoterol 400/12

Flamboyant 200/12 Placebo OTHER

Flamboyant 200/12 Placebo capsule

Budesonide/formoterol 400/12

Budesonide / Formoterol 400/12 Placebo OTHER

Budesonide / Formoterol 400/12 Placebo capsule

FLAMBOYANT 200/12

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• EMS: lead

Study Sites (1)

IMC Tatuí

Tatuí, São Paulo, Brazil

RECRUITING

Related Publications (1)

• Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.

  PMID: 36472162 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Alexandra Dumont Alves, MD

CONTACT

+551938879851; pesquisa.clinica@ncfarma.com.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind and double-dummy
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: December 9, 2019
• Study Start: July 22, 2022
• Primary Completion: July 1, 2023
• Study Completion: October 1, 2023
• Last Updated: July 27, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)