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New asthma inhaler faces off against standard treatment in major trial

NCT ID NCT07318350

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 174 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

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

12 to 65 years

Sex

Anyone

Healthy volunteers

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

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

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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