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NCT00368446 · ClinicalTrials.gov registry record
Genetic Disorders of Mucociliary Clearance in Nontuberculous Mycobacterial Lung Disease
A clinical trial, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- 87
- Enrollment target
NCT00368446: Completed study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT00368446 is a clinical trial that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 87 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00368446 has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- 87 participants
- Enrollment target
Study Summary
Healthy volunteers and patients with diseases that involve problems clearing mucus from the lungs will be examined and tested to better understand the reasons for recurring lung infections in these patients and to try to develop better ways to diagnose and treat them. The study will also try to identify the genes responsible for these diseases. Healthy volunteers 18 years of age and older and patients 2 years of age or older with suspected primary ciliary dyskinesia (PCD), variant cystic fibrosis (CF) or pseudohypoaldosteronism (PHA) may be eligible for this study. Patients enrolled in the Natural History Study of Nontuberculous Mycobacteria at NIH or other NIH natural history protocols may also be enrolled. Participants undergo the following tests and procedures during a 1-day visit at the NIH Clinical Center, as follows: All patients and normal volunteers have the following procedures: * Physical examination and review of medical and genetic history and family genetic history. * Lung function test and measurement of oxygen saturation level. * Nitric oxide measurement to measure the amount of nitric oxide production in the nose: A small tube is placed in the nose while the subject breathes through the mouth into a cardboard tube. All patients have the following additional procedures: * Blood tests for liver and kidney function, blood count, immunoglobulins and pregnancy test (where appropriate). * Blood test or buccal scrape (brushing the inside of the cheek) to obtain DNA to look for gene mutations that cause PCD, CF or PHA. * Scrape biopsy of cell lining the inside of the nose: A small toothpick-sized plastic stick with a tiny cup on the end is used to get nasal lining cells to look at the cilia (hair-like structures that move mucus). * Semen analysis (in some men) to test sperm tail function or structure. Patients suspected of having a variant of CF or PHA, including nontuberculous mycobacterial lung disease, have the following additional procedures: * Sw
Primary Outcome
compatible clinical phenotype (sinopulmonary disease and/or neonatal respiratory disorder plus or minus situs inversus) or sibling with PCD, plus defect in ciliary ultrastructure (inner or outer dynein arm; radial spoke; central complex)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 87 participants |
| Start Date | 2006-10-17 |
| Est. Completion | 2013-06-18 |
What the finished NCT00368446 record still lists
NCT00368446 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 87 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT00368446 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00368446 about?
NCT00368446 is a clinical study titled "Genetic Disorders of Mucociliary Clearance in Nontuberculous Mycobacterial Lung Disease". Healthy volunteers and patients with diseases that involve problems clearing mucus from the lungs will be examined and tested to better understand the reasons for recurring lung infections in these patients and to try to develop better ways to diagnose and treat them. The study will also try to iden...
What is the current status of trial NCT00368446?
This trial is currently completed. The enrollment target is 87 participants. The study started on 2006-10-17. Estimated completion is 2013-06-18.
Who is sponsoring clinical trial NCT00368446?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
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