New asthma inhaler faces off against standard treatment in major trial
NCT ID NCT07318350
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This Phase 3 trial tests a new inhaler called N0783 against a standard asthma inhaler (Alenia) in 174 adults with moderate asthma. The goal is to see if the new drug works just as well at improving lung function and controlling symptoms. Participants will be randomly assigned to one of the two inhalers and monitored for 12 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- N0783 (a fixed-dose combination inhaler)
- What this could lead to
- If it works, this could offer a new treatment option for people with moderate asthma that is as effective as current therapies.
- What could go wrong
- This is an early-stage Phase 3 trial with only 174 participants, so results may not apply to everyone. The new drug might not be as good as the standard treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 174 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.