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New study peers inside lungs to uncover cystic fibrosis damage

NCT ID NCT04549077

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 15, 2026 · Updated 2 times

Summary

This study aims to understand how small blood vessels in the lungs change as cystic fibrosis (CF) lung disease progresses. Researchers will use imaging to measure blood vessel volume in 86 people with CF aged 5-21. The goal is to learn more about the disease, not to test a new treatment.

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 help doctors understand how cystic fibrosis damages lungs over time, potentially guiding future treatments.
What could go wrong
This is an observational study, not testing a treatment. It may not lead directly to new therapies, and results may not apply to all patients.

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

86 people

The number who actually took part.

Started

Jul 2020

Expected to finish

Jan 2027

An estimate. End dates often move.

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

93 subjects with cystic fibrosis, 5-21 years of age, equally divided between males and females will be recruited from 2 CF centers; Cincinnati Children's Hospital and Riley Children's Hospital.

Ages

5 to 21 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.

Cystic Fibrosis Patients: Inclusion Criteria: * 5-21 years of age * diagnosis of CF based on a positive sweat test and genetic testing * Baseline pulmonary condition defined as a) Absence of signs and symptoms of pulmonary exacerbation, b) Baseline pulmonary function test (PFT) defined as FEV1% that is no less than 5% of the best PFT in the previous 6 months, c) Patients should be off acute antibiotics for 2 weeks or longer. * Subjects should be able to perform an acceptable and reproducible spirometry * Study population will be equally divided between three groups based on FEV1%, (FEV1% ≥ 90); moderate (60 ≤ FEV1% \< 90) Exclusion Criteria: * Enrollment in clinical trials of CFTR correctors and or potentiator * Enrollment in gene therapy trial * Pregnancy. Historical Controls Inclusion Criteria: * solid tumor diagnosis * had chest CT scan to survey possible metastasis or any other lung disease * age and gender matched to Cystic Fibrosis patients

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229-3026, United States

  • Riley Hospital for Children

    Indianapolis, Indiana, 46204-3509, United States

More trials for these conditions

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