AsthmaPhase 3NCT04191447
Efficacy and Safety of Flamboyant 200/12 Association in the Treatment of Adults With Severe Asthma
A Phase 3 study testing Flamboyant 200/12 and Budesonide / Formoterol 400/12 in people with Asthma, run by EMS at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Flamboyant 200/12 association in adults with asthma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Flamboyant 200/12 and Budesonide / Formoterol 400/12
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 134 participants
- Where
- 1 siteBrazil
- Study dates
- 22 Jul 2022to Oct 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
IMC Tatuí
Tatuí, São Paulo
Wladmir F Saporito, MD
About this study
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 .
The purpose of this study is to evaluate the efficacy and safety of Flamboyant 200/12 association in adults with asthma.
- Conditions
- Asthma
- Being tested
- Flamboyant 200/12, Budesonide / Formoterol 400/12, Flamboyant 200/12 Placebo, Budesonide / Formoterol 400/12 Placebo
- Keywords
- Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flamboyant 200/12Drug
Flamboyant 200/12 capsule
Budesonide / Formoterol 400/12Drug
Budesonide / Formoterol 400/12 capsule
Flamboyant 200/12 PlaceboOther
Flamboyant 200/12 Placebo capsule
Budesonide / Formoterol 400/12 PlaceboOther
Budesonide / Formoterol 400/12 Placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Budesonide / Formoterol 400/12; Other: Flamboyant 200/12 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Forced expiratory volume in 1 second (FEV1), obtained through espirometry.
Measured: 12 weeks
Secondary outcomes (1)
Incidence and severity of adverse events recorded during the study.
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start22 Jul 2022
- Primary completionJul 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by EMSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EMS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04191447
- Sponsor's protocol ID
- EMS0319 - FLAMBOYANT200/12
- Status last verified
- Jul 2022
- First submitted
- 5 Dec 2019
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36472162
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 .
- ClinicalTrials.gov ID
- NCT04191447
- Acronym / sponsor ID
- EMS0319 - FLAMBOYANT200/12
- Conditions
- Asthma
- Keywords
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2022 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 9 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of Flamboyant 200/12 association in adults with asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FLAMBOYANT 200/12 | Experimental | Drug: Flamboyant 200/12, Other: Budesonide / Formoterol 400/12 PlaceboThe 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. |
| Budesonide/formoterol 400/12 | Active comparator | Drug: Budesonide / Formoterol 400/12, Other: Flamboyant 200/12 PlaceboThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flamboyant 200/12Flamboyant 200/12 capsule | Drug | FLAMBOYANT 200/12 |
| Budesonide / Formoterol 400/12Budesonide / Formoterol 400/12 capsule | Drug | Budesonide/formoterol 400/12 |
| Flamboyant 200/12 PlaceboFlamboyant 200/12 Placebo capsule | Other | Budesonide/formoterol 400/12 |
| Budesonide / Formoterol 400/12 PlaceboBudesonide / Formoterol 400/12 Placebo capsule | Other | FLAMBOYANT 200/12 |
Primary outcome
Change from baseline in Forced expiratory volume in 1 second (FEV1), obtained through espirometry.
Time frame: 12 weeks
1 secondary outcome
Incidence and severity of adverse events recorded during the study.
Time frame: 14 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- Derived from this study: PubMed 36472162Oba 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Flamboyant 200/12 and Budesonide / Formoterol 400/12 in people with Asthma, run by EMS at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandra Dumont Alves, MD (+551938879851, pesquisa.clinica@ncfarma.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Forced expiratory volume in 1 second (FEV1), obtained through espirometry. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04191447, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2022.