Back to resultsEfficacy and Safety of Flamboyant 125/12 Association in the Treatment of Adults With Moderate Asthma
Primary Purpose
Asthma
Status
Recruiting
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Flamboyant 125/12
Budesonide/formoterol 200/6
Flamboyant 125/12 Placebo
Budesonide/formoterol 200/6 placebo
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring Asthma
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 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.
Sites / Locations
- Insight Pesquisa ClínicaRecruiting
- IMC TatuíRecruiting
- CPCLinRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
FLAMBOYANT 125/12
Budesonide/formoterol 200/6
Arm Description
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.
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.
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
1. Study Identification
Unique Protocol Identification Number
NCT04191434
Brief Title
Efficacy and Safety of Flamboyant 125/12 Association in the Treatment of Adults With Moderate Asthma
Official Title
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 .
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
May 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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Flamboyant 125/12 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 125/12
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 125/12 capsule
1 Budesonide/formoterol 200/6 Placebo capsule.
Arm Title
Budesonide/formoterol 200/6
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 200/6 capsule
1 Flamboyant 125/12 Placebo capsule.
Intervention Type
Drug
Intervention Name(s)
Flamboyant 125/12
Intervention Description
Flamboyant 125/12 capsule
Intervention Type
Drug
Intervention Name(s)
Budesonide/formoterol 200/6
Intervention Description
Budesonid/formoterol 200/6 capsule
Intervention Type
Other
Intervention Name(s)
Flamboyant 125/12 Placebo
Intervention Description
Flamboyant 125/12 Placebo capsule
Intervention Type
Other
Intervention Name(s)
Budesonide/formoterol 200/6 placebo
Intervention Description
Budesonid/formoterol 200/6 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
No
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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandra Dumont Alves, MD
Phone
+551938879851
Email
pesquisa.clinica@ncfarma.com.br
Facility Information:
Facility Name
Insight Pesquisa Clínica
City
Porto Alegre
State/Province
Rio Grande Do Sul
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cynthia Dullius
Facility Name
IMC Tatuí
City
Tatuí
State/Province
São Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Name
CPCLin
City
São Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Flávio G Lastebasse, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy and Safety of Flamboyant 125/12 Association in the Treatment of Adults With Moderate Asthma
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