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Breath sniffing may reveal early clues to cystic fibrosis drug success

NCT ID NCT05726994

Knowledge-focused Sponsor: Assistance Publique - Hôpitaux de Paris 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This study explores whether analyzing the chemicals in exhaled breath can detect early changes in children with cystic fibrosis who start taking a medication called Kaftrio. Researchers will collect breath samples from 50 children under 12 before and after they begin treatment, looking for shifts in volatile organic compounds (VOCs) that might signal the drug is working. The goal is to develop a non-invasive way to monitor treatment response without needles or scans.

What this could mean

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

Active substance
exhaled breath collection
What this could lead to
If successful, this could lead to a simple breath test to monitor how well CFTR modulators are working in young children with cystic fibrosis.
What could go wrong
This is a small pilot study, so results may not apply broadly. The breath profile changes may be too subtle or variable to be clinically useful.

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

50 people

The number who actually took part.

Started

Feb 2023

Finished

Jul 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.

Who is studied

Children with cystic fibrosis aged 6 to 12 who will start Kaftrio® treatment.

Ages

2 years and older

Sex

Anyone

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 with cystic fibrosis initiating Kaftrio® treatment. * Patients and holders of parental authority not opposing participation in this research. * Patients affiliated to a Health Insurance system or beneficiaries. Exclusion Criteria * Patients deprived of liberty or under guardianship. * Pregnant or breastfeeding patients. * Lung transplanted patients.

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Conditions

The condition(s) this trial relates to.

cystic fibrosis

As listed by the trial registrant

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

Cystic fibrosis

Contacts and locations

Locations

  • Hôpital Necker - Enfants malades

    Paris, Île-de-France Region, 75015, France

More trials for these conditions

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