Moderate AsthmaPhase 3FORASMANCT07318350
Study of Formoterol 6 mcg/Fluticasone 125 mcg by Eurofarma Laboratórios S.A. Versus Alenia® 6 mcg/200 mcg in Patients With Asthma (FORASMA)
A Phase 3 study testing N0783 and Alenia® (Formoterol 6 mcg / Budesonide 200 mcg) in people with Moderate Asthma, run by Eurofarma Laboratorios S.A..
Trial summary
This is a Phase 3, multicenter, randomized, parallel-group, open-label, non-inferiority clinical trial designed to evaluate the efficacy and safety of N0783 compared to Alenia® (Formoterol 6 mcg / Budesonide 200 mcg) in the treatment of moderate asthma. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Moderate Asthma
- What is being tested?
- N0783 and Alenia® (Formoterol 6 mcg / Budesonide 200 mcg)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Sep 2028
- 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 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥ 12 and ≤ 65 years at Screening.
- History of recurrent asthma symptoms (cough, wheezing, shortness of breath, chest tightness).
- Previous medical diagnosis of asthma (confirmed by records, prescriptions, or participant report).
- Documented reversible airway obstruction by spirometry: FEV₁ increase ≥ 200 mL and ≥ 12% post-bronchodilator (at screening or prior report).
- Moderate asthma (GINA step 3) for ≥ 6 months, clinically stable and controlled with LABA + low-dose inhaled corticosteroid for ≥ 90 days.
- ACQ-7 score ≤ 0.75 at Screening.
- At Randomization: ACQ-7 score ≤ 0.75 and ≥ 70% adherence during run-in.
Who cannot join
- Moderate/severe asthma exacerbation within 90 days prior to screening.
- Other pulmonary disease (including predominant COPD).
- Symptomatic acute or chronic respiratory infection.
- BMI ≥ 40 kg/m².
- Use of LAMA within 6 months prior to screening.
- Oral or depot corticosteroids within 30 days prior to screening.
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- Biologic therapy for asthma, allergic rhinitis, or urticaria within 12 months prior to screening.
- Systemic vasoconstrictors within 7 days prior to screening.
- Known hypersensitivity to formoterol, fluticasone, budesonide, or any component of study drugs.
- Active pulmonary tuberculosis or fungal airway infection.
- History or presence of ischemic heart disease, severe arrhythmias, cardiac decompensation, idiopathic subvalvular aortic stenosis, severe hypertension, aneurysm, pheochromocytoma, hypertrophic obstructive cardiomyopathy, thyrotoxicosis, QTc > 450 ms.
- History of hyperthyroidism or uncontrolled diabetes mellitus.
- Severe or uncontrolled disease at investigator's discretion.
- Pregnancy or breastfeeding; women of childbearing potential not using effective contraception.
- Participation in another clinical trial within 12 months unless direct benefit expected.
- Any condition making participant unsuitable for study per investigator.
- At Randomization: asthma exacerbation during run-in, prohibited medication use, HbA1c ≥ 10%, TSH below normal, ALT or AST > 2× ULN, serum potassium below normal, severe renal impairment (eGFR < 30 mL/min/1.73m²), clinically significant ECG changes or QTc > 450 ms, or any abnormality making participant unsuitable.
About this study
Official title: Phase 3, Multicenter, Randomized, Parallel-group, Open-label, Non-inferiority Study of N0783 Versus Comparator (Formoterol 6 mcg / Budesonide 200 mcg) in the Treatment of Moderate Asthma
This is a Phase 3, multicenter, randomized, parallel-group, open-label, non-inferiority clinical trial designed to evaluate the efficacy and safety of N0783 compared to Alenia® (Formoterol 6 mcg / Budesonide 200 mcg) in the treatment of moderate asthma. Adult patients diagnosed with moderate asthma according to clinical and functional criteria will be enrolled. The primary objective is to demonstrate that N0783 is not inferior to Alenia® in improving asthma control. Participants will receive treatment according to the assigned intervention and will be monitored through scheduled visits for assessment of lung function, symptom control, and safety parameters throughout the study period.
- Conditions
- Moderate Asthma
- Being tested
- N0783, Alenia® (Formoterol 6 mcg / Budesonide 200 mcg)
- Keywords
- Asthma, Moderate Asthma, Alenia®, Non-inferiority, Randomized Clinical Trial, Phase 3
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N0783Drug
N0783 is a fixed-dose combination administered via inhalation using a metered-dose inhaler. Participants will receive the study drug according to the dosing regimen specified in the protocol for the treatment of moderate asthma.
Alenia® (Formoterol 6 mcg / Budesonide 200 mcg)Drug
Alenia® is a fixed-dose combination of Formoterol 6 mcg and Budesonide 200 mcg administered via inhalation using a metered-dose inhaler. Participants will receive the comparator drug according to the dosing regimen specified in the protocol for the treatment of moderate asthma.
| Study group | Role | What they receive |
|---|---|---|
| N0783 | Experimental | Participants will receive N0783 administered via inhalation according to the dosing regimen specified in the protocol for the treatment of moderate asthma. Receives: Drug: N0783 |
| Alenia® | Active comparator | Participants will receive Alenia® (Formoterol 6 mcg / Budesonide 200 mcg) administered via inhalation according to the dosing regimen specified in the protocol for the treatment of moderate asthma. Receives: Drug: Alenia® (Formoterol 6 mcg / Budesonide 200 mcg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change in pre-bronchodilator FEV₁ (L) from baseline to Week 12
Improvement in pre-bronchodilator forced expiratory volume in one second (FEV₁), assessed by spirometry. The absolute change in FEV₁ (in liters) will be measured at Week 12 (Final Visit) compared to baseline (Randomization Visit).
Measured: 12 weeks after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study startOct 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionSep 2028 (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
- 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
- NCT07318350
- Sponsor's protocol ID
- EF195
- Acronym
- FORASMA
- Status last verified
- Oct 2026
- First submitted
- 23 Dec 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3, Multicenter, Randomized, Parallel-group, Open-label, Non-inferiority Study of N0783 Versus Comparator (Formoterol 6 mcg / Budesonide 200 mcg) in the Treatment of Moderate Asthma
- ClinicalTrials.gov ID
- NCT07318350
- Acronym / sponsor ID
- FORASMA / EF195
- Conditions
- Moderate Asthma
- Keywords
- Asthma, Moderate Asthma, Alenia®, Non-inferiority, Randomized Clinical Trial, Phase 3
- 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
- Oct 2026 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 6 Jan 2026 (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.
This is a Phase 3, multicenter, randomized, parallel-group, open-label, non-inferiority clinical trial designed to evaluate the efficacy and safety of N0783 compared to Alenia® (Formoterol 6 mcg / Budesonide 200 mcg) in the treatment of moderate asthma. Adult patients diagnosed with moderate asthma according to clinical and functional criteria will be enrolled. The primary objective is to demonstrate that N0783 is not inferior to Alenia® in improving asthma control. Participants will receive treatment according to the assigned intervention and will be monitored through scheduled visits for assessment of lung function, symptom control, and safety parameters throughout the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N0783 | Experimental | Drug: N0783Participants will receive N0783 administered via inhalation according to the dosing regimen specified in the protocol for the treatment of moderate asthma. |
| Alenia® | Active comparator | Drug: Alenia® (Formoterol 6 mcg / Budesonide 200 mcg)Participants will receive Alenia® (Formoterol 6 mcg / Budesonide 200 mcg) administered via inhalation according to the dosing regimen specified in the protocol for the treatment of moderate asthma. |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 12 and ≤ 65 years at Screening.
- History of recurrent asthma symptoms (cough, wheezing, shortness of breath, chest tightness).
- Previous medical diagnosis of asthma (confirmed by records, prescriptions, or participant report).
- Documented reversible airway obstruction by spirometry: FEV₁ increase ≥ 200 mL and ≥ 12% post-bronchodilator (at screening or prior report).
- Moderate asthma (GINA step 3) for ≥ 6 months, clinically stable and controlled with LABA + low-dose inhaled corticosteroid for ≥ 90 days.
Key exclusion criteria (17 listed)
- Moderate/severe asthma exacerbation within 90 days prior to screening.
- Other pulmonary disease (including predominant COPD).
- Symptomatic acute or chronic respiratory infection.
- BMI ≥ 40 kg/m².
- Use of LAMA within 6 months prior to screening.
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 |
|---|---|---|
| N0783N0783 is a fixed-dose combination administered via inhalation using a metered-dose inhaler. Participants will receive the study drug according to the dosing regimen specified in the protocol for the treatment of moderate asthma. | Drug | N0783 |
| Alenia® (Formoterol 6 mcg / Budesonide 200 mcg)Alenia® is a fixed-dose combination of Formoterol 6 mcg and Budesonide 200 mcg administered via inhalation using a metered-dose inhaler. Participants will receive the comparator drug according to the dosing regimen specified in the protocol for the treatment of moderate asthma. | Drug | Alenia® |
Primary outcome
Absolute change in pre-bronchodilator FEV₁ (L) from baseline to Week 12
Time frame: 12 weeks after treatment initiation
Improvement in pre-bronchodilator forced expiratory volume in one second (FEV₁), assessed by spirometry. The absolute change in FEV₁ (in liters) will be measured at Week 12 (Final Visit) compared to baseline (Randomization 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 23 Oct 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing N0783 and Alenia® (Formoterol 6 mcg / Budesonide 200 mcg) in people with Moderate Asthma, run by Eurofarma Laboratorios S.A..
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 7 inclusion and 17 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 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 FEV₁ (L) from baseline to Week 12 (time frame: 12 weeks after treatment initiation). 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 23 Oct 2026.