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Screening for Primary Ciliary Dyskinesia Using Nasal Nitric Oxide

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2009 by Ziv Hospital.
Recruitment status was:  Not yet recruiting
Information provided by:
Ziv Hospital Identifier:
First received: August 21, 2008
Last updated: August 15, 2009
Last verified: August 2009

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.

Primary Ciliary Dyskinesia

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Screening for Primary Ciliary Dyskinesia Using Nasal Nitric Oxide

Resource links provided by NLM:

Further study details as provided by Ziv Hospital:

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

Estimated Enrollment: 6000
Study Start Date: July 2010

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

Inclusion Criteria:

  • Voluntary willing to participate

Exclusion Criteria:

  • Recent URTI
  • Steroids use 2 weeks prior to testing
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00739817

Contact: Israel Amirav, MD 97246828712

Pediatric Department, Ziv Medical Center Not yet recruiting
Safed, Israel
Contact: Israel Amirav, MD    9726828712   
Sponsors and Collaborators
Ziv Hospital
  More Information

Responsible Party: Israel Amirav, Ziv Medical center Identifier: NCT00739817     History of Changes
Other Study ID Numbers: HP-6-199-R
Study First Received: August 21, 2008
Last Updated: August 15, 2009

Additional relevant MeSH terms:
Ciliary Motility Disorders
Kartagener Syndrome
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Bronchial Diseases
Respiratory System Abnormalities
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Situs Inversus
Genetic Diseases, Inborn
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants processed this record on September 19, 2017