Recruiting

Observational Study

Sponsor:

Indiana University

Code:

NCT07288827

Conditions

Primary Ciliary Dyskinesia

Healthy

Eligibility Criteria

Sex: All

Age: 6+

Healthy Volunteers: Accepted

Interventions

Lung Function Testing

Phlebotomy

Allergy skin prick testing

Methacholine Challenge

Study Details

Brief summary:

The purpose of this study is to look at children with PCD and see if they have another condition called "bronchial hyperresponsiveness".

Conditions

Primary Ciliary Dyskinesia

Healthy

Study ID

NCT07288827

Start date

May 4, 2023

Status verified date

Nov, 2025

Completion date

Apr 30, 2028

Anticipated

Primary completion date

Apr 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Subjects with Primary Ciliary Dyskinesia

Subjects will come to Riley Hospital for Children for at least two visits with the opportunity for a third visit. Each visit should take between 2 and 2.5 hours. During the visits, subjects will complete multiple breathing tests, inhale certain medications, complete a family history questionnaire, have skin allergy testing, and do a blood draw.

experimental: Healthy Subjects

Subjects will come to Riley Hospital for Children for at least two visits with the opportunity for a third visit. Each visit should take between 2 and 2.5 hours. During the visits, subjects will complete multiple breathing tests, inhale certain medications, complete a family history questionnaire, have skin allergy testing, and do a blood draw.

Interventions

Lung Function Testing

will include baseline spirometry (pre- and post- max bronchodilator). All testing will be done according to American Thoracic Society/European Respiratory Society guidelines. Participants will be asked to refrain from taking any asthma medications, including inhaled corticosteroids, short- and long-acting bronchodilators, leukotriene receptor antagonists, and long-acting muscarinic antagonists, for 24 hours prior to any spirometry. This activity will take place at a clinical research center at the respective participating institution.

Phlebotomy

will be obtained at visit 2. Up to ten (10) ml of blood will be collected for measurement of serum biomarkers of atopy, based on whether participants prefer to receive an allergy skin prick test or have antigen-specific IgE levels tested. In the event a subject refuses phlebotomy, historical results up to one year old may be used in lieu of prospective results. Any remaining blood samples will be banked either for use in future studies or in the event that additional serum biomarkers are added to this study.

Allergy skin prick testing

may be completed at visit 2. Subjects will be instructed to withhold first-generation antihistamines for 3 days and second-generation antihistamines for 7 days prior to the test. If patients prefer to have serum antigen-specific IgE levels run with the required serum biomarkers of atopy, then skin prick testing will be omitted.

Methacholine Challenge

If the subject does not demonstrate a bronchodilator response in FEV1 of 10% or greater, and does not have a historical MCT on file, MCT will be performed. Following inhalation of saline, methacholine (MCh) will be inhaled in quadrupling concentrations starting with 0.0625 mg/ml and continuing until the MCh concentration required for FEV1 to decrease by 20% from baseline (PD20) is achieved or a maximum MCh concentration of 16 mg/ml is inhaled.

Primary outcome measure

  • Bronchial Hyperresponsiveness prevalence [ Time Frame: From spirometry baseline measurement (Visit 2) to completion of post-max bronchodilator test (Visit 2) (<1hr) ]
  • Bronchial Hyperresponsiveness prevalence [ Time Frame: From spirometry baseline measurement (Visit 3) to completion of methacholine challenge test (Visit 3) (<1hr) ]
  • Bronchial Hyperresponsiveness prevalence [ Time Frame: From spirometry baseline measurement (Visit 2) to completion of post-max bronchodilator test (Visit 2) (<1hr) ]
  • Bronchial Hyperresponsiveness prevalence comparison [ Time Frame: From first Visit 2 baseline measurement of first subject enrolled to either: last Visit 3 visit of PCD subject who may complete Visit 3; or last Visit 2 visit of PCD subject or Healthy subject, whichever comes latest in enrollment (up to five years) ]

Central Contacts and Locations

Central contacts

Fanmuyi Yang, PhD

317-274-8895fy5@iu.edu

Lisa Bendy

317-278-7152lbendy@iu.edu

Locations

Riley Hospital for Children

Recruiting

Indianapolis, Indiana, United States, 46202

More Information

Sponsor

Indiana University

Last update posted

Dec 17, 2025

Last verified

Nov, 2025

Keywords

  • Primary Ciliary Dyskinesia
  • bronchial hyperresponsiveness

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Indiana University on 2025-12-17.