Bronchial hyperresponsiveness in children with primary ciliary dyskinesia
Official title: A Multi-center Study Examining Bronchial Hyperresponsiveness in Primary Ciliary Dyskinesia
Run by Indiana University · NCT07288827 · Data updated 2026-11-12
This will see if children with primary ciliary dyskinesia have sensitive airways (bronchial hyperresponsiveness) by using a methacholine breathing challenge and related tests.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 6 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Indiana University Academic / other |
| Locations | 1 site (Indianapolis, Indiana) |
| Status | Recruiting |
| Started | May 4, 2023 |
| Main results expected | April 30, 2028 |
| Study ends | April 30, 2028 |
| Registry record updated | December 17, 2025 |
| Trial ID | NCT07288827 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 6 years and older with a confirmed diagnosis of PCD (including positive genetic testing) who can reliably perform pulmonary function testing are ideal candidates.
✕Probably not a fit
Patients who cannot perform lung function testing, have a current pneumothorax, or do not have confirmed PCD are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Children with confirmed primary ciliary dyskinesia aged 6 and older will undergo baseline lung function testing, an incremental methacholine challenge, allergy skin prick testing, and a blood draw. Spirometry (including FEV1) will be measured before and after each methacholine dose while investigators monitor for symptoms such as wheeze or shortness of breath, and the challenge will be stopped if safety thresholds are reached. Bronchodilator treatment will be available to reverse any methacholine-induced narrowing of the airways. The goal is to determine how common airway hyperresponsiveness is in this population to better inform use of daily inhaled steroids.
Why it matters
Potential benefit: If successful, the results could help doctors decide whether children with PCD need daily inhaled steroids, potentially preventing unnecessary medication or ensuring needed treatment.
How similar studies have gone: Methacholine challenge is a standard test for asthma, but few prior studies have systematically measured bronchial hyperresponsiveness specifically in children with PCD, so this application is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Confirmed diagnosis of PCD per standard diagnostic criteria4 and positive genetics * Age greater than or equal to 6 years (no upper age limit) * Any gender or race * Able to perform pulmonary function testing (historical documentation of reversibility will be accepted) Exclusion Criteria: * history of current pneumothorax * inability to perform pulmonary function testing
Where it's running
-
Riley Hospital for Children
Indianapolis, Indiana, United States Recruiting
Study contacts
- Study coordinator: Fanmuyi Yang, PhD
- Email: fy5@iu.edu
- Phone: 317-274-8895
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.