Screening for Primary Ciliary Dyskinesia Using Nasal Nitric Oxide

Primary Ciliary Dyskinesia Clinical Trial

Official title:

Screening for Primary Ciliary Dyskinesia Using Nasal Nitric Oxide

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00739817
• Other study ID #: HP-6-199-R
• Status: Not yet recruiting
• Phase: N/A
• First received: August 21, 2008
• Last updated: August 15, 2009
• Start date: July 2010

Study information

• Verified date: August 2009
• Source: Ziv Hospital
• Contact: Israel Amirav, MD
• Phone: 97246828712
• Email: amirav[@]012.net.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial Summary

Background: Primary ciliary dyskinesia (PCD) is a rare genetic disease characterised by recurrent respiratory infections and subfertility due to dysfunction of cilia (brushes) of the lining cells. Undiagnosed and untreated it can result in an irreversible crippling chronic lung disease. The diagnosis of PCD is a difficult one and involves the complex assessment of ciliary structure and function. Thus, PCD is under diagnosed and appropriate preventative and symptomatic treatment may be denied in many patients. In addition, the gene responsible for PCD is at present unknown, thus preventing pre-natal diagnosis and genetic counseling.

Working hypothesis and aims: Recently, it has become apparent that the evaluation of nasally expired nitric oxide (NO) constitutes a simple and non-invasive diagnostic method, which discriminates between PCD patients, PCD carriers and healthy controls at high rate of specificity and sensitivity. Testing is simple and last approximately one minute. We have recently identified a unique isolated Druze population with high prevalence of PCD. The high frequency of disease places this closed community at a high risk of undiagnosed PCD.

The aim of this project is to use nasal NO measurement as a screening tool to identify possible undiagnosed cases of PCD and PCD carriers in this high risk Druze population.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 6000
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Voluntary willing to participate

Exclusion Criteria:

• Recent URTI

• Steroids use 2 weeks prior to testing

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Ciliary Motility Disorders
• Dyskinesias
• Kartagener Syndrome
• Primary Ciliary Dyskinesia

Locations

Country	Name	City	State
Israel	Pediatric Department, Ziv Medical Center	Safed

Sponsors (1)

Lead Sponsor	Collaborator
Ziv Hospital

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nasal NO < 105 ppb		at enrollment	No