Examining Bronchial Hyperresponsiveness in Primary Ciliary Dyskinesia

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Indiana University
Study ID
NCT07288827
Status
Recruiting
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Conditions

  • Healthy
  • Primary Ciliary Dyskinesia

Eligibility Criteria

Sex
ALL
Age
6 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Lung Function Testing — PROCEDURE
    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 — PROCEDURE
    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 — PROCEDURE
    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 — PROCEDURE
    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.

Study Details

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

Key Dates

Start date
May 4, 2023
Status verified
Nov 2025
Primary completion
Apr 30, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Bronchial Hyperresponsiveness prevalence [ Time Frame: From spirometry baseline measurement (Visit 2) to completion of post-max bronchodilator test (Visit 2) (<1hr) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Riley Hospital for ChildrenIndianapolisIndiana46202
Fanmuyi Yang, PhD

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By research site
Riley Hospital for Children· Indianapolis, IN

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