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Nasal cell test may predict cystic fibrosis drug success

NCT ID NCT03894657

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether a test using cells from the nose can predict if the drug Orkambi® will improve lung function in people with cystic fibrosis. Researchers collected nasal cells from 91 participants before they started Orkambi® and measured how well the drug fixed the cells' function. The goal was to see if this lab test could serve as a biomarker for real-world breathing improvements.

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

91 people

The number who actually took part.

Started

Dec 2019

Finished

May 2022

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

5 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: * Homozygous F508del patient aged 5 years or older * Patient with an indication for Orkambi® treatment according to the marketing authorization application * Patient never received Orkambi® in the past * Patient able to perform FEV1 * Signed Informed consent form by the patient (if aged ≥ 18 years), or by parents / legal guardian and patient's agreement (if aged \< 18 years) Patient affiliated to the health insurance system Exclusion Criteria: * Homozygous F508del patients who do not meet the treatment indications according to the marketing authorization application * Patients refusing Orkambi® * CF patients not homozygous for the p.Phe508del mutation * Active smoker * Severe nasal mucosa disrepair * Contraindications to xylocaine anesthesia, * Participation with another interventional study with drug

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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 Homozygous F508DEL mutation

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.