Natural History of Bronchiectasis
|First Submitted Date||July 21, 2009|
|First Posted Date||July 22, 2009|
|Last Update Posted Date||October 6, 2017|
|Start Date||July 20, 2009|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures
||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 ]|
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT00943514 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures
||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 ]|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||Natural History of Bronchiectasis|
|Official Title||Natural History of Bronchiectasis & Bronchiectasis Patient Registry|
- To study the natural history of bronchiectasis to identify inherited and immune factors that may explain why certain individuals have chronic recurring infections.
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 Design||Observational Model: Other
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
INCLUSION CRITERIA FOR RELATIVES:
As a part of this protocol we may obtain blood, sputum, urine, or buccal swabs from some blood relatives of patients on the study, with the hope of isolating and characterizing the primary host defense defect(s) or genetic links responsible for airway infection susceptibility and/or bronchiectasis seen within families. Male and female relatives will be accepted without limitation due to age. These relatives may have pertinent disease-related history obtained, but will neither receive treatment nor have any other protocol procedures done unless they are enrolled on the study.
PARTICIPANT EXCLUSION CRITERIA:
When a pediatric subject reaches age 18, continued participation will require reconsenting with the adult consent document.
|Ages||5 Years and older (Child, Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||090172
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )|
|Study Sponsor||National Heart, Lung, and Blood Institute (NHLBI)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||July 20, 2017|