A new clinical trial for bronchiectasis, currently recruiting participants, is a prospective observational study which aims to investigate the disease’s natural history, particularly to identify inherited and immune factors that may explain why certain people have chronic recurring infections.
The trial is called “Natural History of Bronchiectasis & Bronchiectasis Patient Registry,” and its ClinicalTrials.gov identifier is NCT00943514.
Sponsored by the National Institutes of Health Clinical Center’s National Heart, Lung, and Blood Institute (NHLBI), the study will investigate the causes and mechanisms for the development of bronchiectasis in patients with chronic and recurring respiratory tract infections.
The primary endpoint of the trial is to document the presence of underlying associated conditions such as variant cystic fibrosis, primary ciliary dyskinesia, common variable immunodeficiency, allergic bronchopulmonary mycosis, and autoimmune disease.
Secondary outcomes include assessing the genetic, systemic immune, and/or epithelial surface defense mechanisms involved in airway infection susceptibility and/or in the development of bronchiectasis, by collecting and storing blood and sputum samples.
People who suffer from bronchiectasis have inflamed, abnormally dilated, and chronically infected airways. They generally have a history of chronic and recurring respiratory infections, and depending on the cause, the infections could involve the entire respiratory tract. This could result in lung, sinus and ear diseases.
Patients eligible to participate in the trial include those who are at least 5 years old with an established diagnosis of bronchiectasis or a history of chronic or recurring respiratory infections. Males and females can enroll, and there is no regard to race and ethnicity and no upper-age limit.
While the study’s emphasis is primarily non-cystic fibrosis bronchiectasis for elucidation of mechanisms of infection susceptibility, patients with cystic fibrosis or acquired immune defects (such as HIV) may also be allowed to participate if the host medical condition is potentially interesting to pursue or for comparison purposes. And, direct family members of patients including parents, siblings and children may also be required to participate.
For more information about trial, please click on the link or contact the following entities, referring to the clinical trial identifier NCT00943514.
Chevalia Robinson, R.N., 301-496-3973; email [email protected].gov
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, U.S. 20892
Contact: Patient Recruitment and Public Liaison Office, 800-411-1222, ext. TTY8664111010; email [email protected]
Principal investigator: Kenneth N. Olivier, M.D., National Heart, Lung, and Blood Institute.
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