ClinicalTrials.gg
RecruitingNCT00943514Updated Nov 9, 2026

Natural History of Bronchiectasis

An observational study in Bronchiectasis, Cystic Fibrosis and Autoimmune Disease, sponsored by National Heart, Lung, and Blood Institute (NHLBI). Recruiting at 1 site in United States. Open to participants aged 5 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by National Heart, Lung, and Blood Institute (NHLBI) · Observational

From the registry’s dates

  • Started Aug 2009; still recruiting 17 years 3 months later.
Updated Nov 2, 2026Interventions changedEligibility revised+1 moreGo to Updates ↓
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
900
Ages
5 Years to 100 Years
Sex
All
01

Study summary

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.
Read the detailed description

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, including those covered by Medicare.

02

Conditions studied

  • Bronchiectasis
  • Cystic Fibrosis
  • Autoimmune Disease
  • Common Variable Immunodeficiency

Keywords

  • Variant Cystic Fibrosis
  • Bronchopulmonary Mycosis
  • Airway Infection Susceptibility
  • Chronic Respiratory Infection
  • Primary Ciliary Dyskinesia
  • Natural History
03

In context

Bronchiectasis

404 studies on the registry are indexed under Bronchiectasis; 125 are open to participants now.

This study's planned enrollment of 900 is above the median of 160 across 137 observational studies indexed under Bronchiectasis.

Browse Bronchiectasis studies →

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI) is the lead sponsor of 1,143 studies on the registry; 71 are open to participants now.

Of its 58 completed or terminated interventional studies of FDA-regulated products, 51 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Oct 30, 2026. See what changed

Ages eligible
5 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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. Relatives including 5 years and above.

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. 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 ) 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 , 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:

    <!-- -->

    1. Patients who are unable or unwilling to provide
    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.

Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
900 participants (estimated)

Groups and cohorts

  • 1

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

06

What researchers measure

Primary outcomes

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

    We will document the presence of underlying associated conditions such as; a. Variant cystic fibrosis through assessment of sweat chloride.b. Primary ciliary dyskinesia through assessment of nasal nitric oxide production, mucosal scrapes for transmission electron microscopy of ciliary ultrastructure.c. Primary immunodeficiency through measurement of quantitative immunoglobulins, specific antigen responses , and lymphocyte phenotyping. d. Allergic bronchopulmonary mycosis through measurement of total immunoglobulin E (IgE), fungal serologies, and skin test responses.e. Autoimmune disease by screening for associated conditions such as inflammatory bowel disease or rheumatoid arthritis.f. Alpha-1 antitrypsin deficiency by assessment of protein levels, phenotype, and gene type.g. Other diagnoses

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

Secondary outcomes

  1. 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

    a.\<TAB\>Patient Global Impression of Severity (PGI-S) b.\<TAB\>Quality of Life Questionnaire-Bronchiectasis (QOL-B)c.\<TAB\>Chronic Airways Assessment Test (CAAT) d.\<TAB\>Bronchiectasis Health Questionnaire (BQH)e.\<TAB\>Child Chronic Cough-Specific Quality of Life (CC-QOL (7-17 years))f.\<TAB\>Parent Cough-Specific Quality of Life (PC-QOL Parent completed (2-18 years))g.\<TAB\>Six-minute walk h.\<TAB\>Chest CT i.\<TAB\>Lung function: FEV1%predicted, FVC% predicted, response to bronchodilator, lung volumes, LCI, and DLCOj.\<TAB\>Lower airway microbiology, as well as novel biomarkers of mycobacteria, antimicrobial resistance and microbial changes on the progression of bronchiectasis. k.\<TAB\>Inflammatory markers

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

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

    We will also assess the following mechanisms and clinical outcomes:1) Systemic immune, and/or epithelial surface defense mechanisms involved in airway infection susceptibility and/or development of bronchiectasis through the:a.\<TAB\>Collection and storage of blood, sputum, and stoolb.\<TAB\>Use and storage of other relevant biologic specimens, such as bronchoalveolar lavage fluid or \*endobronchial biopsy specimens of respiratory epithelium

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

07

Study locations

1 of 1 sites recruiting
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
    Recruiting
    • For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) · Contactccopr@nih.gov · 800-411-1222
08

References and documents

Publications

  • Lunich A, Radtke AJ, Williams M, Stern JM, Barber DL, Germain RN, Anidi IU. Optimized Workflow for Iterative Bleaching Extends Multiplexity Imaging of Highly Autofluorescent Clinical Samples. J Vis Exp. 2025 Jul 11;(221). doi: 10.3791/67980. PubMed 40720370 ↗

Individual participant data

Plan to share: Yes — Refer to the DMSP

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: Refer to the DMSP

Access criteria: Refer to the DMSP

09

Timeline

4 registry updates since Sep 25, 2026

Started Aug 2009 (actual).

How these figures are worked out, and which studies are left out of them.

Registered
Jul 21, 2009
First posted
Jul 22, 2009
StartActual
Aug 1, 2009
Last update
Nov 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Eligibility
6 criteria edited, 9 added, 3 removed
What changed in the criteria
  • EditedPARTICIPANT INCLUSION CRITERIA:
  • EditedChildren 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.
  • EditedEmphasis will be primarily on non CF bronchiectasis for elucidation of mechanisms ofbronchiectasis 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.
  • EditedSubjects must be willing to have samples (blood, tissue, sputum, and stool) stored
  • RemovedINCLUSION CRITERIA FOR RELATIVES:
  • RemovedAs 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.
  • AddedInclusion 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.
  • AddedINCLUSION OF VULNERABLE PARTICIPANTS
  • AddedRationale for inclusion of children:
  • AddedThe 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:
  • AddedAffected 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.
  • AddedMinors 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.
  • AddedRational 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.
  • AddedStudy 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.
  • EditedPARTICIPANT EXCLUSION CRITERIA:
  • RemovedWe 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.
  • Added<!-- -->
  • EditedPatients who are unable or unwilling to provide informed consent either directly or via appropriately designated surrogate.
Oct 30, 2026
Interventions
Arms removed: 2
Nov 2, 2026
Primary outcomes
1 edited
What changed in the outcomes
  • EditedIdentifyThe primary objective of this study is to identify causes and/or underlying conditions associated with bronchiectasis.Time frame: Patients will be seen at least every 6 months for the first 2 years, and then at 1-5 year intervals to follow the course of their disease for 5 years or until they no longer wish to return. → Baseline, annually, and optional exacerbation visits, or until they no longer wish to return.
Oct 30, 2026
Secondary outcomes
2 edited
What changed in the outcomes
  • Edited2) Monitor a cohort of bronchiectasis patients to better understand factors associated with progression of disease and to assess outcomes of management and therapeutic strategies.Time frame: Patients will be seen at least every 6 months for the first 2 years, and then at 1-5 year intervals to follow the course of their disease for 5 years or until they no longer wish to return. → Baseline, annually, and optional exacerbation visits. or until they no longer wish to return.
  • Edited1) Define mechanisms and pathophysiology for the development and progression of bronchiectasisTime frame: Patients will be seen at least every 6 months for the first 2 years, and then at 1-5 year intervals to follow the course of their disease for 5 years or until they no longer wish to return. → Baseline, annually, and optional exacerbation visits. or until they no longer wish to return.
Oct 30, 2026
Show all 4 updates
  1. Nov 9, 2026
    Minor edits only
    + 1 other change: description
  2. Nov 5, 2026
    Minor edits only
    + 1 other change: description
  3. Nov 2, 2026
    Interventions Arms removed: 2
  4. Oct 30, 2026
    Eligibility 6 criteria edited, 9 added, 3 removed
    What changed in the criteria
    • EditedPARTICIPANT INCLUSION CRITERIA:
    • EditedChildren 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.
    • EditedEmphasis will be primarily on non CF bronchiectasis for elucidation of mechanisms ofbronchiectasis 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.
    • EditedSubjects must be willing to have samples (blood, tissue, sputum, and stool) stored
    • RemovedINCLUSION CRITERIA FOR RELATIVES:
    • RemovedAs 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.
    • AddedInclusion 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.
    • AddedINCLUSION OF VULNERABLE PARTICIPANTS
    • AddedRationale for inclusion of children:
    • AddedThe 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:
    • AddedAffected 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.
    • AddedMinors 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.
    • AddedRational 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.
    • AddedStudy 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.
    • EditedPARTICIPANT EXCLUSION CRITERIA:
    • RemovedWe 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.
    • Added<!-- -->
    • EditedPatients who are unable or unwilling to provide informed consent either directly or via appropriately designated surrogate.
    Primary outcomes 1 edited
    What changed in the outcomes
    • EditedIdentifyThe primary objective of this study is to identify causes and/or underlying conditions associated with bronchiectasis.Time frame: Patients will be seen at least every 6 months for the first 2 years, and then at 1-5 year intervals to follow the course of their disease for 5 years or until they no longer wish to return. → Baseline, annually, and optional exacerbation visits, or until they no longer wish to return.
    Secondary outcomes 2 edited
    What changed in the outcomes
    • Edited2) Monitor a cohort of bronchiectasis patients to better understand factors associated with progression of disease and to assess outcomes of management and therapeutic strategies.Time frame: Patients will be seen at least every 6 months for the first 2 years, and then at 1-5 year intervals to follow the course of their disease for 5 years or until they no longer wish to return. → Baseline, annually, and optional exacerbation visits. or until they no longer wish to return.
    • Edited1) Define mechanisms and pathophysiology for the development and progression of bronchiectasisTime frame: Patients will be seen at least every 6 months for the first 2 years, and then at 1-5 year intervals to follow the course of their disease for 5 years or until they no longer wish to return. → Baseline, annually, and optional exacerbation visits. or until they no longer wish to return.
    + 5 other changes: verification date, description, arm descriptions, contact details and data sharing statement

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT00943514
Responsible party
Sponsor
First posted
Jul 22, 2009
Start date
Aug 1, 2009
Last update
Nov 9, 2026

Study contacts

Chevalia J Robinson, R.N.
Contact
robinsoc1@nih.gov
(301) 496-3973
Pamela J McShane, M.D.
principal investigator · National Heart, Lung, and Blood Institute (NHLBI)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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