Examining Bronchial Hyperresponsiveness in Primary Ciliary Dyskinesia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6+
SponsorIndiana University
About this trial
The purpose of this study is to look at children with PCD and see if they have another condition called "bronchial hyperresponsiveness".
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
history of current pneumothorax
inability to perform pulmonary function testing
Trial design
Design model
Parallel
Treatments tested in this trial
Lung Function Testing
Procedure/Surgerywill 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/Surgerywill 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/Surgerymay 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/SurgeryIf 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Subjects with Primary Ciliary DyskinesiaExperimental treatment 4 interventions
Group B: Healthy SubjectsExperimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
Bronchial Hyperresponsiveness prevalence
Examine how many subjects with PCD have bronchial hyperresponsiveness as evidenced by an increase in FEV1 of 10% or greater during pre- and post- max bronchodilator test.
Time frame
From spirometry baseline measurement (Visit 2) to completion of post-max bronchodilator test (Visit 2) (<1hr)2
Bronchial Hyperresponsiveness prevalence
Examine how many subjects with PCD have bronchial hyperresponsiveness as evidenced by a decline in FEV1 by 20% from baseline during methacholine challenge test.
Time frame
From spirometry baseline measurement (Visit 3) to completion of methacholine challenge test (Visit 3) (<1hr)3
Bronchial Hyperresponsiveness prevalence
Examine how many healthy subjects have bronchial hyperresponsiveness as evidenced by an increase in FEV1 of 10% or greater during pre- and post- max bronchodilator test.
Time frame
From spirometry baseline measurement (Visit 2) to completion of post-max bronchodilator test (Visit 2) (<1hr)4
Bronchial Hyperresponsiveness prevalence comparison
Compare the prevalence of bronchial hyperresponsiveness (examined in Outcome 1, Outcome 2) in PCD subjects to bronchial hyperresponsiveness in age- and gender-matched healthy controls.
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)Secondary outcomes
1
Data Collection of PCD genotype/phenotype
These data points will be a compilation of chronic rhinosinusitis, respiratory distress at birth, recurrent upper and lower airway infections, and/or fertility issues, serum biomarkers for atopy, and other clinical features and explore the relationship between PCD and bronchial hyperresponsiveness, which can manifest as coughing, wheezing, and/or chest tightness.
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)2
Analysis of the relationship between PCD and atopy
This will address whether bronchial hyperresponsiveness in PCD is due to an underlying predisposition similar to that seen in asthma and whether it could relate to some other mechanism such as antigen mucostasis.
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)Sponsors and contacts
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Source ClinicalTrials.gov