Natural History of Bronchiectasis
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00943514|
Recruitment Status : Recruiting
First Posted : July 22, 2009
Last Update Posted : May 23, 2018
- 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.
- Patients older than 18 years of age will be invited to join the Bronchiectasis Research Registry, a program supported by the Chronic Obstructive Pulmonary Disease (COPD) Foundation. The purpose of the program is to identify a group of people who are interested in receiving information about research studies focused on bronchiectasis and possibly participating in these research studies. Participants may be offered the opportunity to participate in selected clinic trials related to bronchiectasis or related medical conditions.
|Condition or disease|
|Bronchiectasis Cystic Fibrosis Autoimmune Disease Common Variable Immunodeficiency|
Bronchiectasis, or abnormal dilation of the airways, is a condition typically characterized by chronic and recurring respiratory tract infections. Frequently, depending on the underlying cause, these infections involve the entire respiratory tract resulting in sinus, ear, and lung disease. This condition used to be more common in children prior to immunizations for childhood infections. It continues to be a significant problem in developing countries and in specific groups of individuals in the U.S. Cystic fibrosis (CF) is the most commonly associated genetic condition and tremendous strides have been made in recent years in understanding the mechanisms of this disease that are leading to a multitude of emerging novel treatment strategies. The mechanisms of other causes for bronchiectasis have not evolved to this degree, and many of the disease-specific treatments being assessed for cystic fibrosis may not be effective for non-CF bronchiectasis. Often bronchiectasis can be associated with chronic infections from environmental germs such as the nontuberculous mycobacteria.
This protocol is aimed at exploring associated causes and mechanisms for the development of bronchiectasis in patients with chronic and recurring respiratory tract infections. Participants will undergo testing based on their individual clinical presentations to look for known associated conditions. Additionally, some patients may be followed over time to better understand the natural history of evolving bronchiectasis and to assess the effect of management strategies on the course of the disease and on their chronic infections like the nontuberculous mycobacteria. As potential novel therapies develop, participants may be offered the opportunity to participate in clinical treatment trials.
|Study Type :||Observational|
|Estimated Enrollment :||900 participants|
|Official Title:||Natural History of Bronchiectasis & Bronchiectasis Patient Registry|
|Study Start Date :||July 20, 2009|
- Document the presence of underlying associated conditions such as: Variant cystic fibrosis, Primary ciliary dyskinesia, Common variable immunodeficiency, Allergic bronchopulmonary mycosis, Autoimmune dx, Autoimmune dx, alpha-1 antitrypsin defici... [ Time Frame: 10 years ]
- Assessment of genetic, systemic immune, and/or epithelial surface defense mechanisms involved in airway infection susceptibility and/or in the development of bronchiectasis through the:a)Collection and storage of blood and sputumb)Use and ... [ Time Frame: 10 years ]
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) firstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator:||Kenneth N Olivier, M.D.||National Heart, Lung, and Blood Institute (NHLBI)|