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Hope for young CF patients: new drug may ease sinus troubles

NCT ID NCT05581056

Symptom relief Sponsor: Hospices Civils de Lyon 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study looked at 27 children aged 6 to 11 with cystic fibrosis who were starting treatment with CFTR modulators (Kaftrio). The goal was to see if the drug improves nose and sinus symptoms and quality of life after one year. Researchers used a special questionnaire called SN-5 to measure changes. The study is complete, and results may help confirm whether these drugs help with sinus issues in younger children.

What this could mean

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

Active substance
CFTR modulators (Kaftrio)
What this could lead to
If successful, this could show that CFTR modulators improve nose and sinus symptoms and quality of life in young children with cystic fibrosis.
What could go wrong
This is a small, completed study with only 27 participants, so results may not apply to all children. The treatment is already approved for older ages, but its effect on nasal symptoms in this age group is still uncertain.

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

27 people

The number who actually took part.

Started

Mar 2023

Finished

Sep 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 between 6 and 11 years of age

Ages

6 to 11 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: * Children between 6 and 11 years of age * Compatible genotype and patient treated with KAFTRIO (treatment initiation is independent of this study) Exclusion Criteria: * Refusal of the child or the holder of parental authority to participate in the study. * Child not affiliated to a social security system and under legal protection * Holder of parental authority who does not master the French language Secondary Exclusion Criteria: * Sinus surgery during the observation period * Poor tolerance of the treatment (pneumological opinion)

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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 Femme Mère Enfant

    Bron, Rhone, 69500, France

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