No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
5 – 100
Sex
Any
Study type
Observational
Participants needed
900 (estimated)
Sponsor
National Heart, Lung, and Blood Institute (NHLBI) · NIH
Who this trial is looking for
This trial is looking for individuals aged 5 and older who have bronchiectasis or a history of recurring respiratory infections. Participants will be screened to check their health history and may provide samples for further analysis.
Are You a Good Fit for This Trial?
You may be able to join if
I am 5 years or older.
I have been diagnosed with bronchiectasis.
I have a history of chronic or recurring respiratory infections.
I am a direct family member of a patient in the study.
I have a primary doctor.
I am willing to have samples stored.
You may not be able to join if
I have common respiratory problems like asthma or allergies.
I am unable to provide informed consent.
I am not willing to comply with follow-up.
I am under 5 years old.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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 Locations
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Eligibility Criteria
* INCLUSION CRITERIA:
1. Children age 5 years and above and adults referred to the NIH with chronic or recurring respiratory infections and/or bronchiectasis will be eligible for participation.
2. Males and females will be considered without regard to race or ethnicity or upper age limit.
3. …
* INCLUSION CRITERIA:
1. Children age 5 years and above and adults referred to the NIH with chronic or recurring respiratory infections and/or bronchiectasis 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 bronchiectasis development and 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 (blood, tissue, sputum, and stool) stored
6. Inclusion Criteria for Relatives including children ages 5 years and above; relatives without a known diagnosis of bronchiectasis, including those who are asymptomatic, may be enrolled if they are willing to complete study assessments. These participants will be used for comparative analyses and/or screening for previously undiagnosed disease.
INCLUSION OF VULNERABLE PARTICIPANTS
Rationale for inclusion of children:
The research that is conducted on this protocol is regulated by Health and Human Services, and in compliance with federal guidelines Title 45 Code of Federal Regulations, Part 46, Subpart D. The groups of children that may be included are:
Affected minors: Bronchiectasis may have early onset and a significant impact on the lives of these patients. It is important to include this population in our study in order to understand the natural history and progression of this condition in children as they often have physiological differences as compared to adult patients. Affected minors may undergo testing that will be tailored to their specific clinical presentation.
Minors that are related to affected individuals: Children that are relatives of index patients may not be affected or show symptoms. It is important for relatives including minor relatives to be enrolled in our study, in order to help us identify the possible conditions like pre-bronchiectasis to better understand the mechanism of the disease progression. Unaffected child relatives may only undergo tests that are no greater than minimal risk.
Rational for inclusion of affected pregnant and or nursing women: Pregnant and or nursing women including pregnant minors may be included in accordance with Federal Regulations at Subpart B of 45 CFR 46. Bronchiectasis-related symptoms and respiratory status may change during pregnancy. Including pregnant participants in this observational natural history protocol will allow the study to capture longitudinal changes in clinical status and other relevant data during pregnancy and the postpartum period.
Study procedures conducted during pregnancy and breastfeeding will be limited to those determined to pose no more than minimal risk to the participant and fetus or breastfeeding infant. Procedures considered greater than minimal risk -including computed tomography scans, bronchoscopy with bronchoalveolar lavage and endobronchial biopsy, and research blood collection- will not be performed during pregnancy or breastfeeding. These procedures may be completed after the participant is no longer pregnant and, when applicable, has discontinued breastfeeding, in accordance with the protocol and investigator judgment.
EXCLUSION CRITERIA:
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1. Patients who are unable or unwilling to provide informed consent
2. 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.
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