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Screening for Primary Ciliary Dyskinesia Using Nasal Nitric Oxide

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00739817
Recruitment Status : Unknown
Verified August 2009 by Ziv Hospital.
Recruitment status was:  Not yet recruiting
First Posted : August 22, 2008
Last Update Posted : August 18, 2009
Sponsor:
Information provided by:
Ziv Hospital

Brief 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.


Condition or disease
Primary Ciliary Dyskinesia

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Study Type : Observational
Estimated Enrollment : 6000 participants
Time Perspective: Prospective
Official Title: Screening for Primary Ciliary Dyskinesia Using Nasal Nitric Oxide
Study Start Date : July 2010

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Nasal NO < 105 ppb [ Time Frame: at enrollment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
community
Criteria

Inclusion Criteria:

  • Voluntary willing to participate

Exclusion Criteria:

  • Recent URTI
  • Steroids use 2 weeks prior to testing

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00739817


Contacts
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Contact: Israel Amirav, MD 97246828712 amirav@012.net.il

Locations
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Israel
Pediatric Department, Ziv Medical Center
Safed, Israel
Contact: Israel Amirav, MD    9726828712    amirav@012.net.il   
Sponsors and Collaborators
Ziv Hospital
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Responsible Party: Israel Amirav, Ziv Medical center
ClinicalTrials.gov Identifier: NCT00739817    
Other Study ID Numbers: HP-6-199-R
First Posted: August 22, 2008    Key Record Dates
Last Update Posted: August 18, 2009
Last Verified: August 2009
Additional relevant MeSH terms:
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Ciliary Motility Disorders
Dyskinesias
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Ciliopathies
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn