Natural History of Bronchiectasis
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|ClinicalTrials.gov Identifier: NCT00943514|
Recruitment Status : Recruiting
First Posted : July 22, 2009
Last Update Posted : November 18, 2020
- Bronchiectasis is a disease characterized by airways that are inflamed, abnormally dilated, and chronically infected. Individuals with bronchiectasis have a history of chronic and recurring respiratory infections. Depending on the underlying cause, these infections may involve the entire respiratory tract, resulting in sinus, ear, and lung disease.
- Bronchiectasis continues to be a significant problem in developing countries and in specific groups of individuals, particularly in people who have cystic fibrosis. Although treatments are available or under development for bronchiectasis related to cystic fibrosis, many of the disease-specific treatments may not be effective for bronchiectasis not related to cystic fibrosis.
- To study the natural history of bronchiectasis to identify inherited and immune factors that may explain why certain individuals have chronic recurring infections.
- Individuals 5 years of age and older who have an established diagnosis of bronchiectasis or a history of chronic/recurring respiratory infections.
- Direct family members (e.g., parents, siblings, children) of patients in the study may also be asked to participate.
- Potential participants will be screened with an initial clinic evaluation and full medical history, as well as a general quality of life and respiratory symptom questionnaire.
- The following standard procedures may be done as part of the study: air sampling from the nose; imaging studies, which may include an x-ray or computed tomography (CT), lung function tests; and collection of samples of blood, urine, and sputum (phlegm or mucus). Other tests may be performed as required by the researchers, and will be explained to patients as needed.
- Both patients and relatives (if asked to participate) will provide the following samples: blood or buccal (cheek swab) cells for genetic testing, sputum, and urine.
- To prevent infections and potential disease progression, patients may receive standard medical care and treatment for bronchiectasis and related infections during this protocol.
|Condition or disease|
|Bronchiectasis Cystic Fibrosis Autoimmune Disease Common Variable Immunodeficiency|
|Study Type :||Observational|
|Estimated Enrollment :||900 participants|
|Official Title:||Natural History of Bronchiectasis|
|Actual Study Start Date :||August 1, 2009|
chronic or recurring respiratory infections including pulmonary nontuberculous mycobacterial disease
- We will document the presence of underlying associated conditions such as a. Variant cystic fibrosis, b. Primary ciliary dyskinesia, c. Common variable immunodeficiency, d. Allergic bronchopulmonary mycosis, e. Autoimmune disease, Autoimmune dis... [ Time Frame: 2 yrs ]Collection of clinically indicated, standardized outcome measures will facilitate assessment of ongoing management strategies.
- Genetic, systemic immune, and/or epithelial surface defense mechanisms involved in airway infection susceptibility and/or development of bronchiectasis [ Time Frame: 2 yrs ]
- Assessment of clinical outcomes utilizing standardized measuresduring follow-up visits [ Time Frame: 2 yrs ]
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): NCT00943514
|Contact: Chevalia Robinson, R.N.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Kenneth N Olivier, M.D.||National Heart, Lung, and Blood Institute (NHLBI)|