Natural History of Bronchiectasis

Launched by NATIONAL HEART, LUNG, AND BLOOD INSTITUTE (NHLBI) · Jul 21, 2009

Keywords

ClinConnect Summary

This clinical trial is studying bronchiectasis, a condition where the airways in the lungs become inflamed and damaged, leading to repeated respiratory infections. The researchers aim to understand why some people with bronchiectasis experience chronic infections while others do not, particularly focusing on inherited and immune factors. This study is open to individuals aged 5 and older who have been diagnosed with bronchiectasis or have a history of chronic respiratory infections. Family members of these patients may also be invited to participate.

Participants in the trial can expect to undergo a variety of assessments, including medical evaluations, lung function tests, and the collection of samples such as blood and sputum for further analysis. These tests will help researchers identify the underlying causes of bronchiectasis and improve future treatments. While participating, patients will continue to receive standard medical care for their condition. This trial is currently recruiting, and it welcomes individuals regardless of race, gender, or whether they have cystic fibrosis. If you're interested in learning more or think you might qualify, please talk to your doctor.

Gender

ALL

Eligibility criteria

• * PARTICIPANT INCLUSION CRITERIA:
• • 1. Children age 5 years and above and adults referred to the NIH with chronic or recurring respiratory infections will be eligible for participation.
• • 2. Males and females will be considered without regard to race or ethnicity or upper age limit.
• • 3. Emphasis will be primarily on non CF bronchiectasis for elucidation of mechanisms of infection susceptibility. However, select patients with cystic fibrosis or acquired immune defects (such as HIV) may be studied if relevant host defects are suspected, if needed for comparison purposes, or to evaluate and study the management of chronic pathogen associated conditions such as nontuberculous mycobacterial infections or allergic bronchopulmonary aspergillosis.
• • 4. Subjects must have a primary or referring physician
• • 5. Subjects must be willing to have samples stored
• 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:
• • 1. We wish to avoid enrolling subjects, especially children, who have common respiratory problems (aeroallergen sensitivity, asthma, gastric esophageal reflux) that are not associated with an underlying abnormality in host defenses. Evidence of significance of chronic or recurring infections suggestive of an underlying airway surface or systemic host defense defect should be documented by one or more of the following: a) sinus or lower airway cultures positive for bacterial, fungal, or mycobacterial pathogens characteristic of these defects; or b) radiographic evidence of sinusitis with mucosal thickening and/or air-fluid levels; or c) radiographic evidence of bronchiectasis; d) severity of otitis media requiring placement of tympanic membrane pressure equalization tubes; e) severity of sinusitis requiring surgical intervention.
• • 2. Patients who are unable or unwilling to provide informed consent either directly or via appropriately designated surrogate.
• • 3. Any patient who, in the opinion of the Investigator, is unable or unwilling to comply with regular follow-up or is unlikely to provide pertinent information regarding disease progression or response to treatment may be excluded from longitudinal follow-up.
• PARTICIPATION OF CHILDREN:
• • Children under the age of 5 will be excluded from this protocol due to the difficulty of performing pertinent assays in infants and younger children, difficulty distinguishing significance of respiratory infections which occur commonly in younger children, and the lack of adequate facilities and equipment for management of children younger than 2 years.