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Could a simple breath test replace specialist diagnosis for lung disease?

NCT ID NCT07245576

Diagnosis Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Sep 21, 2026 · Updated 2 times

Summary

This study is testing whether two simple breathing tests—oscillometry and FeNO—can help primary care doctors accurately diagnose asthma and COPD, compared to the usual specialist methods. Researchers will enroll 600 adults with suspected asthma or COPD across six countries. If these tests work well, they could speed up diagnosis and reduce the need for specialist visits.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could make diagnosing asthma and COPD faster and easier in primary care, reducing the need for specialist referrals.
What could go wrong
This is an observational study, not a treatment trial. The new tests may not prove accurate enough to replace current methods, and results may vary across different settings.

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.

Participants

About 600 people

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

Started

Dec 2025

Expected to finish

Apr 2027

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.

Who is studied

Total of 600 patients (approximately 300 suspected asthma patients and 300 suspected COPD patients) will be enrolled in this study. The patients will be enrolled in asthma or COPD groups in 1:1 ratio at site-level. Each site will enroll 50 patients (approximately 25 suspected asthma and 25 suspected COPD).

Ages

18 years and older

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: Patients are eligible to be included in the study if all the following criteria apply and after providing written informed consent: Suspected asthma (asthma group) 1. Patients ≥ 18 years old or with legal age of consent in the jurisdiction in which the study is taking place, at the time of signing the ICF. 2. Patients presenting with symptoms of wheezing, cough, chest tightness, shortness of breath, but without a clinically confirmed diagnosis of asthma. Suspected COPD (COPD group) 1. Patients ≥ 40 years old at the time of signing the ICF. 2. Patients presenting with symptoms of dyspnea, chronic cough or sputum production, but without a clinically confirmed diagnosis of COPD. Exclusion Criteria: Patients are excluded from the study if any of the following criteria apply: 1. Prior diagnosis of COPD or asthma. 2. Use of ICS in the last 6 months or use of oral corticosteroids in the last 3 months. 3. Any diseases that influence lung function result such as lung cancer, pneumonia, active pulmonary tuberculosis, pulmonary embolism, and interstitial lung disease. 4. Any history of recent surgery that affects lung function results, including but not limited to thoracotomy surgery, pneumothorax surgery, and thoracic drainage. 5. Contraindication to spirometry or oscillometry test, or allergy to bronchodilator. 6. Currently pregnant or breast-feeding women. 7. If the investigator judges that the patient is unlikely to comply with study procedures, restrictions, and requirements.

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Conditions

The condition(s) this trial relates to.

asthma chronic obstructive pulmonary disease COPD, severe early onset

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Asthma COPD

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    12 sites in 7 countries. The list below names each one and where it is.

  2. 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 ↗

  3. 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.

Contacts and locations

Locations

  • Research Site

    RECRUITING

    Buenos Aires, Argentina

  • Research Site

    RECRUITING

    Medoza, Argentina

  • Research Site

    NOT_YET_RECRUITING

    Alexandria, Egypt

  • Research Site

    NOT_YET_RECRUITING

    El Waili, Egypt

  • Research Site

    NOT_YET_RECRUITING

    Monterrey, Mexico

  • Research Site

    NOT_YET_RECRUITING

    Santiago de Quer Taro, Mexico

  • Research Site

    NOT_YET_RECRUITING

    Riyadh, Saudi Arabia

  • Research Site

    NOT_YET_RECRUITING

    Taichung, Taiwan

  • Research Site

    NOT_YET_RECRUITING

    Taoyuan City, Taiwan

  • Research Site

    NOT_YET_RECRUITING

    Dubai, United Arab Emirates

  • Research Site

    NOT_YET_RECRUITING

    Hanoi, Vietnam

  • Research Site

    NOT_YET_RECRUITING

    Ho Chi Minh City, Vietnam

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