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 .
1 other identifier
interventional
134
1 country
3
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Flamboyant 125/12 association in adults with asthma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 asthma
Started Jul 2022
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 5, 2019
CompletedFirst Posted
Study publicly available on registry
December 9, 2019
CompletedStudy Start
First participant enrolled
July 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2023
CompletedJuly 27, 2022
July 1, 2022
9 months
December 5, 2019
July 25, 2022
Conditions
Keywords
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 125/12
EXPERIMENTALThe 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.
Budesonide/formoterol 200/6
ACTIVE COMPARATORThe 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.
Interventions
Eligibility Criteria
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 moderate 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 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- EMSlead
Study Sites (3)
Insight Pesquisa Clínica
Porto Alegre, Rio Grande do Sul, Brazil
IMC Tatuí
Tatuí, São Paulo, Brazil
CPCLin
São Paulo, Brazil
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: 36472162DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
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
May 1, 2023
Study Completion
October 1, 2023
Last Updated
July 27, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share