Moderate AsthmaPhase 3FORASMANCT05735431
Non-Inferiority,Combination Formoterol/FluticasonexAlenia®Formoterol/Budesonide for Asthma in Brazil
A Phase 3 study testing Administration of investigation drug and Administration of comparator in people with Moderate Asthma, run by Eurofarma Laboratorios S.A. at 1 site in Brazil.
Trial summary
Eurofarma Laboratórios S.A. markets a FDC containing formoterol 12 mcg/fluticasone 250 mcg, in a single capsule for inhalation (Lugano®; reference product). The product is indicated for the treatment of asthma in patients aged ≥ 12 years. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Moderate Asthma
- What is being tested?
- Administration of investigation drug and Administration of comparator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2026to Nov 2027
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients of both sexes who meet all of the following criteria will be included in the study:
- Signature of the Informed Consent Term (ICF) for people over 18 years and, when applicable, signature of the Informed Assent Form (IAF) by the participant under 18 years of age and the ICF by the representative before carrying out any study procedure.
- Age ≥ 12 years.
- History of recurrent symptoms suggestive of asthma (cough, wheezing, shortness of breath, and/or chest tightness).
- Previous medical diagnosis of asthma.
Who cannot join
- Patients who meet at least one of the following criteria will be excluded from the study:
- Occurrence of moderate to serious asthma exacerbation within 90 days prior to initiation of study treatment.
- Presence of acute or chronic symptomatic respiratory tract infection.
- Body mass index (BMI) ≥ 38 kg/m2.
- Use of long-acting anticholinergic drug (LAMA) in the last six (06) months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 3, Multicenter, Randomized, Parallel-Group, Open-Label, Comparative Non-Inferiority Fixed-Dose Combination Formoterol 6 mcg/Fluticasone 125 mcg Versus Alenia® (Formoterol 6 mcg/Budesonide 200 mcg) in the Treatment of Moderate Asthma
Eurofarma Laboratórios S.A. markets a FDC containing formoterol 12 mcg/fluticasone 250 mcg, in a single capsule for inhalation (Lugano®; reference product). The product is indicated for the treatment of asthma in patients aged ≥ 12 years. The company seeks to register a product with lower concentrations of mono-drugs (6 mcg and 125 mcg, respectively) to enable the dosage step up and step down treatment strategies advocated by the Global Initiative for Asthma for the inhaled maintenance treatment of asthma (GINA, 2022 ) with these combinations.
This Phase 3 study will be carried out for demonstrating the non-inferiority of the investigational drug (FDC of formoterol 6 mcg/fluticasone 125 mcg) compared to the FDC of formoterol 6 mcg/budesonide 200 mcg (Alenia® - Aché Laboratórios Farmacêuticos S.A.) in the maintenance treatment of asthma, allowing its registration as a new concentration of the drug already registered by the company.
Read the detailed description
The investigational drug consists of a fixed-dose combination (FDC) that contains formoterol fumarate dihydrate , a long-acting β2-agonist (LABA), and fluticasone propionate , a glucocorticoid, powder for inhalation contained in a single capsule, in concentrations of 6 mcg and 125 mcg per capsule, respectively. The investigational drug consists of a fixed-dose combination (FDC) that contains formoterol fumarate dihydrate , a long-acting β2-agonist (LABA), and fluticasone propionate , a glucocorticoid, powder for inhalation contained in a single capsule, in concentrations of 6 mcg and 125 mcg per capsule, respectively.The investigational drug consists of a fixed-dose combination (FDC) that contains formoterol fumarate dihydrate , a long-acting β2-agonist (LABA), and fluticasone propionate , a glucocorticoid, powder for inhalation contained in a single capsule, in concentrations of 6 mcg and 125 mcg per capsule, respectively. Multicenter, randomized, parallel-group, open-label, comparative non-inferiority clinical trial. After a run-in period of four (04) weeks, during which all participants will receive Alenia® 6 mcg/200 mcg, patients with moderate asthma (step 3) controlled according to the criteria of the Global Initiative for Asthma (GINA, 20221) will be randomized in a 1:1 ratio to receive the FDC of formoterol 6 mcg/fluticasone 125 mcg Eurofarma (investigational drug) or Alenia® 6 mcg/200 mcg (comparator drug) (one [01] inhalation, twice a day) for 12 weeks. The primary non-inferiority assessment will be performed at the end of the 12 weeks of treatment. 2The study will be conducted in an open-label scenario, since the inhalation devices for the products have different aspects, making it impossible to blind the study treatments. The objective nature of the primary efficacy variable (forced expiratory volume in one second [FEV1]) minimizes potential bias arising from the open-label nature of the study. The duration of treatment (12 weeks) was defined based on the guidelines of the Global Initiative for Asthma (GINA 20221) and the Brazilian Society of Pulmonology and Phthisiology (SBPT) regarding the time required to assess the effectiveness of asthma maintenance treatments (three months).
- Conditions
- Moderate Asthma
- Being tested
- Administration of investigation drug, Administration of comparator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of investigation drugDrug
Also called Formoterol 6 mcg/fluticasone 125 mcg
Participants randomized to this group will receive 1 inhalation of the product, twice daily, for 12 weeks.
Administration of comparatorDrug
Also called Alenia® 6 mcg/200 mcg
Participants randomized to this group will receive 1 inhalation of the product, twice daily, for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Formoterol 6 mcg/fluticasone 125 mcg | Experimental | Formoterol 6 mcg/fluticasone 125 mcg Eurofarma. Receives: Drug: Administration of investigation drug |
| Alenia® 6 mcg/200 mcg | Active comparator | Alenia® 6 mcg/200 mcg. Receives: Drug: Administration of comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change in pre-bronchodilator Forced expiratory volume in one second - Liter, assessed by means of pulmonary function testing 12 weeks after initiation of treatment (Final visit) from baseline (Randomization visit)
Absolute change in pre-bronchodilator Forced expiratory volume in one second - Liter, assessed by means of pulmonary function testing 12 weeks after initiation of treatment (Final visit) from baseline (Randomization visit). The interval between visits is 28 ± 2 days.
Measured: of pulmonary function testing 12 weeks after initiation of treatment (Final visit) from baseline (Randomization visit).
Secondary outcomes (3)
Secondary Efficacy Endpoints - treatment progress
Evolution of the pre-bronchodilator Forced expiratory volume in one second - Liter value throughout the treatment (Randomization visit, Visit 1, Visit 2, and Final visit).The interval between visits is 28 ± 2 days.
Measured: Evolution of the pre-bronchodilator Forced expiratory volume in one second - Liter value throughout the treatment (Randomization visit, Visit 1, Visit 2, and Final visit);
Secondary Efficacy Endpoints - treatment progress
Peak expiratory flow value (Liter/minute) measured in the morning and in the afternoon throughout the treatment (Randomization visit, Visit 1, Visit 2, and Final visit).The interval between visits is 28 ± 2 days.
Measured: Peak expiratory flow value (Liter/minute) measured in the morning and in the afternoon throughout the treatment (Randomization visit, Visit 1, Visit 2, and Final visit);
Secondary Efficacy Endpoints - treatment progress
Final Asthma Control Questionnaire 7 score 12 weeks after starting treatment (Randomization visit, Visit 1, Visit 2, and Final visit).The interval between visits is 28 ± 2 days.
Measured: Final Asthma Control Questionnaire 7 score 12 weeks after starting treatment (Randomization visit, Visit 1, Visit 2, and Final visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study startJun 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Why it stopped: Strategic change in development priorities
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate AsthmaStudies of the same condition, open and under way.
- 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
- Model description
- Enrolled participants will be randomized to one of the following treatment groups: Investigational Group: Formoterol 6 mcg/fluticasone 125 mcg Eurofarma. Participants randomized to this group will receive 1 inhalation of the product, twice daily, for 12 weeks. Comparator Group: Alenia® 6 mcg/200 mcg. Participants randomized to this group will receive 1 inhalation of the product, twice daily, for 12 weeks.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eurofarma Laboratorios S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05735431
- Sponsor's protocol ID
- EF182
- Acronym
- FORASMA
- Status last verified
- May 2025
- First submitted
- 13 Dec 2022
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3, Multicenter, Randomized, Parallel-Group, Open-Label, Comparative Non-Inferiority Fixed-Dose Combination Formoterol 6 mcg/Fluticasone 125 mcg Versus Alenia® (Formoterol 6 mcg/Budesonide 200 mcg) in the Treatment of Moderate Asthma
- ClinicalTrials.gov ID
- NCT05735431
- Acronym / sponsor ID
- FORASMA / EF182
- Conditions
- Moderate Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Strategic change in development priorities
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Eurofarma Laboratorios S.A.Industry (pharma, biotech, devices)
- Study start
- Jun 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 21 Feb 2023 (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.
Eurofarma Laboratórios S.A. markets a FDC containing formoterol 12 mcg/fluticasone 250 mcg, in a single capsule for inhalation (Lugano®; reference product). The product is indicated for the treatment of asthma in patients aged ≥ 12 years. The company seeks to register a product with lower concentrations of mono-drugs (6 mcg and 125 mcg, respectively) to enable the dosage step up and step down treatment strategies advocated by the Global Initiative for Asthma for the inhaled maintenance treatment of asthma (GINA, 2022 ) with these combinations.
This Phase 3 study will be carried out for demonstrating the non-inferiority of the investigational drug (FDC of formoterol 6 mcg/fluticasone 125 mcg) compared to the FDC of formoterol 6 mcg/budesonide 200 mcg (Alenia® - Aché Laboratórios Farmacêuticos S.A.) in the maintenance treatment of asthma, allowing its registration as a new concentration of the drug already registered by the company.
Detailed description
The investigational drug consists of a fixed-dose combination (FDC) that contains formoterol fumarate dihydrate , a long-acting β2-agonist (LABA), and fluticasone propionate , a glucocorticoid, powder for inhalation contained in a single capsule, in concentrations of 6 mcg and 125 mcg per capsule, respectively. The investigational drug consists of a fixed-dose combination (FDC) that contains formoterol fumarate dihydrate , a long-acting β2-agonist (LABA), and fluticasone propionate , a glucocorticoid, powder for inhalation contained in a single capsule, in concentrations of 6 mcg and 125 mcg per capsule, respectively.The investigational drug consists of a fixed-dose combination (FDC) that contains formoterol fumarate dihydrate , a long-acting β2-agonist (LABA), and fluticasone propionate , a glucocorticoid, powder for inhalation contained in a single capsule, in concentrations of 6 mcg and 125 mcg per capsule, respectively. Multicenter, randomized, parallel-group, open-label, comparative non-inferiority clinical trial. After a run-in period of four (04) weeks, during which all participants will receive Alenia® 6 mcg/200 mcg, patients with moderate asthma (step 3) controlled according to the criteria of the Global Initiative for Asthma (GINA, 20221) will be randomized in a 1:1 ratio to receive the FDC of formoterol 6 mcg/fluticasone 125 mcg Eurofarma (investigational drug) or Alenia® 6 mcg/200 mcg (comparator drug) (one [01] inhalation, twice a day) for 12 weeks. The primary non-inferiority assessment will be performed at the end of the 12 weeks of treatment. 2The study will be conducted in an open-label scenario, since the inhalation devices for the products have different aspects, making it impossible to blind the study treatments. The objective nature of the primary efficacy variable (forced expiratory volume in one second [FEV1]) minimizes potential bias arising from the open-label nature of the study. The duration of treatment (12 weeks) was defined based on the guidelines of the Global Initiative for Asthma (GINA 20221) and the Brazilian Society of Pulmonology and Phthisiology (SBPT) regarding the time required to assess the effectiveness of asthma maintenance treatments (three months).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Enrolled participants will be randomized to one of the following treatment groups: Investigational Group: Formoterol 6 mcg/fluticasone 125 mcg Eurofarma. Participants randomized to this group will receive 1 inhalation of the product, twice daily, for 12 weeks. Comparator Group: Alenia® 6 mcg/200 mcg. Participants randomized to this group will receive 1 inhalation of the product, twice daily, for 12 weeks.
| Arm | Type | Receives |
|---|---|---|
| Formoterol 6 mcg/fluticasone 125 mcg | Experimental | Drug: Administration of investigation drugFormoterol 6 mcg/fluticasone 125 mcg Eurofarma. |
| Alenia® 6 mcg/200 mcg | Active comparator | Drug: Administration of comparatorAlenia® 6 mcg/200 mcg. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients of both sexes who meet all of the following criteria will be included in the study:
- Signature of the Informed Consent Term (ICF) for people over 18 years and, when applicable, signature of the Informed Assent Form (IAF) by the participant under 18 years of age and the ICF by the representative before carrying out any study procedure.
- Age ≥ 12 years.
- History of recurrent symptoms suggestive of asthma (cough, wheezing, shortness of breath, and/or chest tightness).
- Previous medical diagnosis of asthma.
Key exclusion criteria (5 listed)
- Occurrence of moderate to serious asthma exacerbation within 90 days prior to initiation of study treatment.
- Presence of acute or chronic symptomatic respiratory tract infection.
- Body mass index (BMI) ≥ 38 kg/m2.
- Use of long-acting anticholinergic drug (LAMA) in the last six (06) months.
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 |
|---|---|---|
| Administration of investigation drugAlso: Formoterol 6 mcg/fluticasone 125 mcgParticipants randomized to this group will receive 1 inhalation of the product, twice daily, for 12 weeks. | Drug | Formoterol 6 mcg/fluticasone 125 mcg |
| Administration of comparatorAlso: Alenia® 6 mcg/200 mcgParticipants randomized to this group will receive 1 inhalation of the product, twice daily, for 12 weeks. | Drug | Alenia® 6 mcg/200 mcg |
Primary outcome
Absolute change in pre-bronchodilator Forced expiratory volume in one second - Liter, assessed by means of pulmonary function testing 12 weeks after initiation of treatment (Final visit) from baseline (Randomization visit)
Time frame: of pulmonary function testing 12 weeks after initiation of treatment (Final visit) from baseline (Randomization visit).
Absolute change in pre-bronchodilator Forced expiratory volume in one second - Liter, assessed by means of pulmonary function testing 12 weeks after initiation of treatment (Final visit) from baseline (Randomization visit). The interval between visits is 28 ± 2 days.
3 secondary outcomes
Secondary Efficacy Endpoints - treatment progress
Time frame: Evolution of the pre-bronchodilator Forced expiratory volume in one second - Liter value throughout the treatment (Randomization visit, Visit 1, Visit 2, and Final visit);
Secondary Efficacy Endpoints - treatment progress
Time frame: Peak expiratory flow value (Liter/minute) measured in the morning and in the afternoon throughout the treatment (Randomization visit, Visit 1, Visit 2, and Final visit);
Secondary Efficacy Endpoints - treatment progress
Time frame: Final Asthma Control Questionnaire 7 score 12 weeks after starting treatment (Randomization visit, Visit 1, Visit 2, and Final visit)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Administration of investigation drug and Administration of comparator in people with Moderate Asthma, run by Eurofarma Laboratorios S.A. 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 5 inclusion and 5 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: withdrawn, as of the sponsor's last update on 18 Dec 2025. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute change in pre-bronchodilator Forced expiratory volume in one second - Liter, assessed by means of pulmonary function testing 12 weeks after initiation of treatment (Final visit) from baseline (Randomization visit) (time frame: of pulmonary function testing 12 weeks after initiation of treatment (Final visit) from baseline (Randomization visit).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Dec 2025.