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

Primary Purpose

Asthma

Status

Recruiting

Phase

Phase 3

Locations

Brazil

Study Type

Interventional

Intervention

Flamboyant 200/12

Budesonide / Formoterol 400/12

Flamboyant 200/12 Placebo

Budesonide / Formoterol 400/12 Placebo

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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 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.

Sites / Locations

IMC TatuíRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FLAMBOYANT 200/12

Budesonide/formoterol 400/12

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence and severity of adverse events recorded during the study.

Full Information

NCT ID

NCT04191447

First Posted

December 5, 2019

Last Updated

July 25, 2022

Sponsor

EMS

1. Study Identification

Unique Protocol Identification Number

NCT04191447

Brief Title

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

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 .

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Recruiting

Study Start Date

July 22, 2022 (Actual)

Primary Completion Date

July 2023 (Anticipated)

Study Completion Date

October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

EMS

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

Asthma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Masking Description

Double-blind and double-dummy

Allocation

Randomized

Enrollment

134 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

FLAMBOYANT 200/12

Arm Type

Experimental

Arm Description

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.

Arm Title

Budesonide/formoterol 400/12

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Flamboyant 200/12

Intervention Description

Flamboyant 200/12 capsule

Intervention Type

Drug

Intervention Name(s)

Budesonide / Formoterol 400/12

Intervention Description

Budesonide / Formoterol 400/12 capsule

Intervention Type

Other

Intervention Name(s)

Flamboyant 200/12 Placebo

Intervention Description

Flamboyant 200/12 Placebo capsule

Intervention Type

Other

Intervention Name(s)

Budesonide / Formoterol 400/12 Placebo

Intervention Description

Budesonide / Formoterol 400/12 Placebo capsule

Primary Outcome Measure Information:

Title

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

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Incidence and severity of adverse events recorded during the study.

Time Frame

14 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Alexandra Dumont Alves, MD

Phone

+551938879851

pesquisa.clinica@ncfarma.com.br

Facility Information:

Facility Name

IMC Tatuí

City

Tatuí

State/Province

São Paulo

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wladmir F Saporito, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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