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 .

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

Study Overview

• Status: Recruiting
• Conditions: Asthma
• Intervention / Treatment: Drug: Flamboyant 125/12; Other: Budesonide/formoterol 200/6 placebo; Drug: Budesonide/formoterol 200/6; Other: Flamboyant 125/12 Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 134
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Alexandra Dumont Alves, MD; Phone Number: +551938879851; Email: pesquisa.clinica@ncfarma.com.br

Study Locations

• Brazil
  • São Paulo, Brazil
    • Recruiting
    • CPCLIN
    • Contact: Flávio G Lastebasse, MD
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil
      • Recruiting
      • Insight Pesquisa Clínica
      • Contact: Cynthia Dullius
  • São Paulo
    • Tatuí, São Paulo, Brazil
      • Recruiting
      • IMC Tatuí

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Flamboyant 125/12; Flamboyant 125/12 capsule; Other: Budesonide/formoterol 200/6 placebo; Budesonid/formoterol 200/6 Placebo capsule
Active Comparator: 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.	Drug: Budesonide/formoterol 200/6; Budesonid/formoterol 200/6 capsule; Other: Flamboyant 125/12 Placebo; Flamboyant 125/12 Placebo capsule

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: EMS

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2022
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: December 5, 2019
• First Submitted That Met QC Criteria: December 5, 2019
• First Posted (Actual): December 9, 2019

Study Record Updates

• Last Update Posted (Actual): July 27, 2022
• Last Update Submitted That Met QC Criteria: July 25, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Asthma
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Budesonide; Formoterol Fumarate; Budesonide, Formoterol Fumarate Drug Combination
• Other Study ID Numbers: EMS0219 - FLAMBOYANT125/12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No