Lung Function Testing for Primary Ciliary Dyskinesia
(BHR Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether children with Primary Ciliary Dyskinesia (PCD), a genetic condition affecting lung function, also experience bronchial hyperresponsiveness (overly sensitive airways). Participants will undergo various tests, including lung function tests, allergy skin prick testing, and the Methacholine Challenge (a test to assess airway sensitivity), to gather information about their breathing and immune response. Those with a confirmed diagnosis of PCD who can perform breathing tests might be suitable candidates, along with healthy individuals for comparison. The goal is to better understand PCD and improve future treatments for those affected by it. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance understanding and treatment of PCD.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to ask the trial coordinators for more details.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
A previous study found allergy skin prick testing to be a quick and relatively comfortable method for detecting allergies. It is commonly used and matches the accuracy of other methods. However, care is needed to prevent false negatives or bleeding from deep pricks.
Lung function testing is also well-tolerated. Research has shown that lung function issues in children with primary ciliary dyskinesia (PCD) are usually milder than in those with cystic fibrosis, indicating that the testing is safe and manageable.
The methacholine challenge, which assesses airway reactivity, is monitored for safety. Participants receive close observation to ensure any changes in lung function are promptly addressed.
Phlebotomy, or drawing blood, is a standard procedure with minimal risk. It involves using a needle to collect blood, a common practice in medical settings.
Overall, these tests are generally safe and well-tolerated, with close monitoring to address any issues that arise.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it aims to improve the understanding of lung function in individuals with Primary Ciliary Dyskinesia (PCD). Unlike typical treatments that focus on managing symptoms, this study explores various diagnostic techniques like lung function tests, allergy skin prick testing, and methacholine challenges to uncover more about how PCD affects breathing. By analyzing these aspects, researchers hope to develop better diagnostic and management strategies for PCD, ultimately leading to improved patient care and outcomes.
What evidence suggests that this trial's treatments could be effective for bronchial hyperresponsiveness?
Research shows that allergy skin prick tests quickly and accurately identify allergens. This helps researchers understand related health issues in people with primary ciliary dyskinesia (PCD). In this trial, participants will undergo lung function tests, which studies have found crucial for monitoring lung performance over time, essential for managing PCD. The methacholine challenge, another test in this trial, assesses airway sensitivity, a condition often seen in PCD patients. Blood tests, or phlebotomy, will gather important health information about children and adults with PCD. Together, these tests provide a clearer picture of how PCD affects lung function and related conditions.13678
Are You a Good Fit for This Trial?
This trial is for children and adults diagnosed with Primary Ciliary Dyskinesia (PCD), aged 6 or older, of any gender or race. Participants must be able to perform lung function tests. Those who cannot do these tests or have a current pneumothorax cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Initial Assessment
Participants undergo initial assessments including breathing tests, family history questionnaire, skin allergy testing, and blood draw
Methacholine Challenge
Participants receive methacholine to test for bronchial hyperresponsiveness, with breathing monitored before and after administration
Follow-up
Participants are monitored for safety and effectiveness after methacholine challenge
What Are the Treatments Tested in This Trial?
Interventions
- Allergy skin prick testing
- Lung Function Testing
- Methacholine Challenge
- Phlebotomy
Trial Overview
The study examines if people with PCD also suffer from bronchial hyperresponsiveness by using lung function testing, blood draws (phlebotomy), allergy skin prick testing, and methacholine challenges to assess their airway sensitivity.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Indiana University
Lead Sponsor
Citations
Primary ciliary dyskinesia: a case report of double DNAH11 ...
Several biological markers, including a normal sweat test, and allergy-related indicators such as skin prick tests and plasma interleukins, were assessed.
Examining Bronchial Hyperresponsiveness in Primary ...
The purpose of this study is to look at children with PCD and see if they have another condition called "bronchial hyperresponsiveness".
3.
karger.com
karger.com/iaa/article/179/4/297/168243/Impact-of-Allergic-Rhinitis-on-Nasal-MucociliaryImpact of Allergic Rhinitis on Nasal Mucociliary Clearance ...
A total of 432 AR patients were monosensitized and 410 multisensitized on the grounds of the skin prick tests and sIgE measurement results. In ...
Clinical Evidence and Biomarkers Linking Allergy and Acute ...
[56•] demonstrated a positive skin prick test in 53% of the cases in a cohort of 110 children with CRS; moreover, those with atopy had higher ...
International consensus statement on allergy and rhinology ...
Skin prick testing (SPT) is a quick and relatively comfortable way to test several antigens with accuracy similar to other available methods of ...
Risk and safety requirements for diagnostic and therapeutic ...
Skin prick should be applied carefully, as insufficient prick may produce false negative results, and induction of bleeding (too deep) may produce false ...
Medical devices in allergy practice
Skin prick test (SPT) is used to detect systemic sensitization to airborne and food allergens, and is used worldwide as first-line diagnostic approach.3, 4, 5, ...
Lung Function Testing for Primary Ciliary Dyskinesia
The study examines if people with PCD also suffer from bronchial hyperresponsiveness by using lung function testing, blood draws (phlebotomy), allergy skin ...
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