NCT00943514

Natural History of Bronchiectasis

StatusRecruiting

PhaseNot specified

SponsorNational Heart, Lung, and Blood Institute (NHLBI)

At risk: Primary endpoint(s) modified.

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Record History

The 50 most recent of 343 versions: 4 with changes below, 46 re-verified with no change. See every version on ClinicalTrials.gov ↗

Notable Oct 30, 2026 Primary endpoint(s) modified
- Trial arms changed: 2 → 1
Notable Oct 29, 2026 Primary endpoint revised
- Eligibility criteria expanded, about 181 words
- Secondary endpoints revised (2)
- Study description shortened, about 22 words
Minor Sep 25, 2026 Secondary endpoints: details revised at 2 of 2 entries
Apr 12, 2025 Study Status, Outcome Measuresv309

Notable: the plan changed
Minor: routine updates

Endpoints

Primary

The primary objective of this study is to identify causes and/or underlying conditions associated with bronchiectasis.

Timeframe: Baseline, annually, and optional exacerbation visits, or until they no longer wish to return.

Secondary (2)

2) Monitor a cohort of bronchiectasis patients to better understand factors associated with progression of disease and to assess outcomes of management and therapeutic strategies

1) Define mechanisms and pathophysiology for the development and progression of bronchiectasis

Arms and interventions

Children age 5 years and above and adults with chronic or recurring respiratory infections and/or bronchiectasis

Sites

1 site in 1 country

National Institutes of Health Clinical CenterBethesda, Maryland, United States

About this trial

Bronchiectasis is a chronic inflammatory and muco-obstructive condition that results in abnormal dilation of the airways, decline in lung function, frequent exacerbations, and chronic respiratory tract infections. Cystic fibrosis (CF) is the most well studied genetic condition that causes bronchiectasis. Tremendous strides made in understanding the mechanisms of CF have led to a multitude of novel treatment strategies that have revolutionized the field. In contrast, the mechanisms of other causes for bronchiectasis remain undetermined and the disease-specific treatments for cystic fibrosis are not effective for non-CF bronchiectasis. Bronchiectasis not caused by CF carries a substantial socioeconomic burden, is a lifelong condition with no cure and, in most cases, has no identifiable cause. Prioritizing research in this important respiratory disease is essential because it affects individuals from children through older adulthood. Background: This protocol is aimed at exploring underlying causes and mechanisms for the development of bronchiectasis. Participants will undergo testing based on their individual clinical presentations to identify underlying causative factors. Additionally, some patients will 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 trials. Objectives: The primary objective of this study is to identify causes and/or underlying conditions associated with bronchiectasis. Eligibility: * 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. Design: * 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....

Trial details

Enrollment: 900 participants (estimated)
Started: Aug 1, 2009
Eligibility: 5 and older, all sexes, healthy volunteers accepted
Design: Observational
Conditions: Autoimmune Diseases, Bronchiectasis, Ciliary Motility Disorders, Common Variable Immunodeficiency, Cystic Fibrosis, Autoimmune Disease
First posted: Jul 22, 2009
Registry updated: Nov 5, 2026
Last verified: Oct 2026

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