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Breathing cold air may reveal asthma better than current tests

NCT ID NCT07220928

Diagnosis Sponsor: KU Leuven Source: ClinicalTrials.gov ↗

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested a cold air breathing challenge in 60 adults (some with asthma, some healthy) to see if it can safely tell the difference between asthma and normal lungs. Researchers measured lung function and symptoms after the test. The goal is to develop a more reliable tool for diagnosing asthma and exercise-related breathing problems.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

60 people

The number who actually took part.

Started

Aug 2023

Finished

Nov 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 between 18 and 65 years old at time of signing informed consent * BMI between 18 and 28 kg/cm2 * Ability to give informed consent and to comply with study protocol, in the investigator's judgement * Non-smoking or ex-smokers for at least 12 months with less than 10 pack years * Normal spirometry Group specific: Histamine positive healthy controls: histamine bronchial challenge test (\< 8 mg/ml) at screening Healthy controls: histamine bronchial challenge test (≥ 8 mg/ml) at screening Patients with asthma: * Physician-diagnosed asthma for at least 6 months * Post-bronchodilator FEV1 of ≥ 80% at screening * Documented airway reversibility either by means of post-bronchodilator reversibility of ≥ 12.% and ≥ 200 ml or in the previous 6 months or by means of documented airway hyperresponsiveness (histamine PC20 \< 4 mg/ml) at screening * Asthma control questionnaire (ACQ) ≤ 1.5 * Regular treatment with ICS with or without LABA (unchanged dose for at least 30 days) at a low or medium dose of ICS Exclusion Criteria: * Previous history of intubation or admission to ICU due to asthma * Severe asthma exacerbation within one month prior to screening visit * Treatment with oral or systemic steroids within one month prior to screening visit * Previous treatment with biologics for asthma * Other major concurrent pulmonary (such as COPD, cystic fibrosis, sarcoidosis, interstitial lung disease, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis, bronchiectasis) or cardiovascular disease * Pregnancy

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Conditions

The condition(s) this trial relates to.

asthma disease

As listed by the trial registrant

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

Asthma (diagnosis)

Contacts and locations

Locations

  • UZ Leuven Gasthuisberg

    Leuven, 3000, Belgium

More trials for these conditions

Other studies related to the condition(s) this trial covers.