InfectionNCT01264055
Cross-sectional Characterization of Idiopathic Bronchiectasis
An observational study of Infection and Bronchial Diseases, run by National Heart, Lung, and Blood Institute (NHLBI) at 6 sites in 2 countries.
Trial summary
Background: Bronchiectasis is a type of lung condition in which the lungs airways are abnormally stretched and widened. This stretching and widening makes it difficult for mucus and other substances to move out of the lungs, encouraging the growth of bacteria and leading to breathing problems or infection. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Infection, Bronchial Diseases, Respiratory Tract Diseases
- How many people
- 275 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 26 Apr 2011to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with idiopathic bronchiectasis, with stratification by gender and by presence/absence of respiratory infection with nontuberculous mycobacteria (NTM)
Who may be able to join
- The criteria for participants to enter the study mandates that each patient have received a standard (current clinical practice) diagnostic evaluation that includes a CT scan of the chest to document bronchiectasis, prior to enrolling in the Consortium study. To enter this protocol, adults must have bronchiectasis and meet the following criteria:
- Males or females, age greater than or equal to18 years
- Chronic cough
- An available CT of the chest (on a CD) that shows evidence of dilated airways fulfilling radiographic criteria for bronchiectasis in more than one lobe
- Ability to provide informed consent, including HIPAA consent
Who cannot join
- A participant should not be in the study if they have not had a standard clinical evaluation to rule out other potential causes of chronic sino-pulmonary disease.
- Known diagnosis of cystic fibrosis with classic clinical presentation and elevated sweat chloride levels and/or two known disease-causing CFTR mutations
- History of tuberculosis or other known explanation for bronchiectasis, such as alpha 1-antitrypsin deficiency (ZZ or ZS), confirmed or probable PCD, inflammatory bowel disease, rheumatoid arthritis, Sjogren s syndrome, allergic bronchopulmonary aspergillosis, or documented primary or acquired immunodeficiency
- Current smoker or > 10 pack-year history of tobacco use
- Prior solid organ transplant
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
National Jewish Health
Denver, Colorado, 80206
Washington University, St. Louis
St Louis, Missouri, 63110
Stanford Medical Center
Stanford, California, 94305
About this study
Official title: Cross-Sectional Characterization of Idiopathic Bronchiectasis
Background:
- Bronchiectasis is a type of lung condition in which the lungs airways are abnormally stretched and widened. This stretching and widening makes it difficult for mucus and other substances to move out of the lungs, encouraging the growth of bacteria and leading to breathing problems or infection. Bronchiectasis can be caused by genetic disorders or diseases such as tuberculosis or rheumatoid arthritis. Researchers are interested in developing better ways to diagnose and treat a lung problem called idiopathic or unexplained bronchiectasis.
Read more
Objectives:
- To better describe the physical characteristics, radiographic patterns, and airway microbiology of unexplained bronchiectasis and to look for possible genetic links or risk factors.
Eligibility:
- Individuals at least 18 years of age who have a chronic cough and who have had a CT scan that has revealed signs of bronchiectasis.
- Current smokers or those who have smoked for at least 10 years, as well as individuals who have known causes of bronchiectasis or who have had organ transplants, are not eligible to participate.
Design:
- Participants will have one outpatient clinic visit for evaluation with a physical examination including detailed body size measurements and medical history and for collection of blood samples for routine lab tests and genetic analyses and a chest x-ray if no recent one is available.
- Participants will also have tests of lung function, and measurement of a gas called nitric oxide in the nose. Participants whose initial tests show abnormal results may also be asked to have a nasal scrape to collect cell samples and/or a skin sweat test to measure salt concentrations.
- Participants will also have a sputum specimen collected during the visit and will be asked to collect two additional early morning sputum samples and a mouth rinse at home within 2 weeks of the clinic visit, and mail the sample collection materials to the research team.
Read the detailed description
The Genetic Disorders of Mucociliary Clearance Consortium (GDMCC) is comprised of 6 geographically-dispersed clinical research sites designed to study chronic disorders of the conducting airways associated with bronchiectasis. The first Clinical Center protocol (06-I-0217) focused on airway diseases with a known genetic etiology: primary ciliary dyskinesia (PCD), variant cystic fibrosis (vCF), and pseudohypoaldosteronism (PHA). This second GDMCC protocol will study adult patients with non-CF, idiopathic bronchiectasis, whose genetic etiologies are not known. Patients will receive the same level of rigorous testing that has allowed proper diagnosis of patients with PCD, vCF, and PHA.
Idiopathic bronchiectasis is reportedly more common in females with certain asthenic morphotypes and associated with environmental organisms, such as nontuberculous mycobacterium (NTM). Gender predilection due to referral bias is unclear. Other susceptibility factors predisposing to bronchiectasis or acquisition of NTM are also unclear.
The study will attempt to broaden the understanding of this disease by comparing gender-associated factors and NTM status. A relatively equal number of both females/males and NTM/non-NTM infected subjects will be accrued. Patients will be stratified by gender and by the presence/absence of respiratory infection with NTM. Approximately 300 people may be screened to find 260 eligible subjects since a small number (e.g., 40 patients) may be diagnosed with PCD, vCF, or other known etiology as an explanation for the bronchiectasis.
This single-visit protocol will use a systematic approach to characterize the clinical, morphological, radiological, and microbiological phenotypes of idiopathic bronchiectasis. Physical features, radiographic patterns, and associated lower airway microbial flora will be assessed. There is no natural history of disease course follow-up component to this protocol. The standard evaluation includes a quantitative assessment of body morphometrics, functional assessments of pulmonary physiology, nasal nitric oxide measurement with subsequent detailed assessment of ciliary structure and motility in selected patients, quantitative immunoglobulins levels to screen for humoral immune defects, and selected genetic analysis of candidate alleles, such as CFTR and A1AT.
Genotype/phenotype correlations will be researched and possibly defined. Careful evaluation and characterization of these phenotypes will guide the genetic characterization of idiopathic bronchiectasis, and likely lead to an improved diagnostic approach. Identification of disease causing genes may provide new therapeutic targets.
- Conditions
- Infection, Bronchial Diseases, Respiratory Tract Diseases
- Keywords
- Rare Disease of Airways, Chronic Cough, Nontuberculous Mycobacteriam Infection, Natural History, Bronchiectasis, Idiopathic Bronchiectasis
- Medical subject headings
- Infections, Bronchial Diseases, Respiratory Tract Diseases, Chronic Cough, Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Adults with idiopathic bronchiectasis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical characteristics by gender and NTM
Clinical characteristics by gender and NTM status including body morphotypes, radiographic patterns, and respiratory flora
Measured: 30 years
Secondary outcomes (1)
Seek to define Genotype/phenotype
Measured: 30 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2010 (estimated)
- Study start26 Apr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 275 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Andrew J Lipton, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01264055
- Sponsor's protocol ID
- 110046
- Other IDs
- 11-H-0046
- Status last verified
- 3 Jun 2026
- First submitted
- 18 Dec 2010
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wanner A, Salathe M, O'Riordan TG. Mucociliary clearance in the airways. Am J Respir Crit Care Med. 1996 Dec;154(6 Pt 1):1868-902. doi: 10.1164/ajrccm.154.6.8970383. No abstract available.
PubMed 8970383
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-Sectional Characterization of Idiopathic Bronchiectasis
- ClinicalTrials.gov ID
- NCT01264055
- Acronym / sponsor ID
- 110046
- Conditions
- Infection, Bronchial Diseases, Respiratory Tract Diseases
- Keywords
- Rare Disease of Airways, Chronic Cough, Nontuberculous Mycobacteriam Infection, Natural History, Bronchiectasis, Idiopathic Bronchiectasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 275 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 26 Apr 2011 (actual)
- First posted
- 21 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- Bronchiectasis is a type of lung condition in which the lungs airways are abnormally stretched and widened. This stretching and widening makes it difficult for mucus and other substances to move out of the lungs, encouraging the growth of bacteria and leading to breathing problems or infection. Bronchiectasis can be caused by genetic disorders or diseases such as tuberculosis or rheumatoid arthritis. Researchers are interested in developing better ways to diagnose and treat a lung problem called idiopathic or unexplained bronchiectasis.
Objectives:
- To better describe the physical characteristics, radiographic patterns, and airway microbiology of unexplained bronchiectasis and to look for possible genetic links or risk factors.
Eligibility:
- Individuals at least 18 years of age who have a chronic cough and who have had a CT scan that has revealed signs of bronchiectasis.
- Current smokers or those who have smoked for at least 10 years, as well as individuals who have known causes of bronchiectasis or who have had organ transplants, are not eligible to participate.
Design:
- Participants will have one outpatient clinic visit for evaluation with a physical examination including detailed body size measurements and medical history and for collection of blood samples for routine lab tests and genetic analyses and a chest x-ray if no recent one is available.
- Participants will also have tests of lung function, and measurement of a gas called nitric oxide in the nose. Participants whose initial tests show abnormal results may also be asked to have a nasal scrape to collect cell samples and/or a skin sweat test to measure salt concentrations.
- Participants will also have a sputum specimen collected during the visit and will be asked to collect two additional early morning sputum samples and a mouth rinse at home within 2 weeks of the clinic visit, and mail the sample collection materials to the research team.
Detailed description
The Genetic Disorders of Mucociliary Clearance Consortium (GDMCC) is comprised of 6 geographically-dispersed clinical research sites designed to study chronic disorders of the conducting airways associated with bronchiectasis. The first Clinical Center protocol (06-I-0217) focused on airway diseases with a known genetic etiology: primary ciliary dyskinesia (PCD), variant cystic fibrosis (vCF), and pseudohypoaldosteronism (PHA). This second GDMCC protocol will study adult patients with non-CF, idiopathic bronchiectasis, whose genetic etiologies are not known. Patients will receive the same level of rigorous testing that has allowed proper diagnosis of patients with PCD, vCF, and PHA.
Idiopathic bronchiectasis is reportedly more common in females with certain asthenic morphotypes and associated with environmental organisms, such as nontuberculous mycobacterium (NTM). Gender predilection due to referral bias is unclear. Other susceptibility factors predisposing to bronchiectasis or acquisition of NTM are also unclear.
The study will attempt to broaden the understanding of this disease by comparing gender-associated factors and NTM status. A relatively equal number of both females/males and NTM/non-NTM infected subjects will be accrued. Patients will be stratified by gender and by the presence/absence of respiratory infection with NTM. Approximately 300 people may be screened to find 260 eligible subjects since a small number (e.g., 40 patients) may be diagnosed with PCD, vCF, or other known etiology as an explanation for the bronchiectasis.
This single-visit protocol will use a systematic approach to characterize the clinical, morphological, radiological, and microbiological phenotypes of idiopathic bronchiectasis. Physical features, radiographic patterns, and associated lower airway microbial flora will be assessed. There is no natural history of disease course follow-up component to this protocol. The standard evaluation includes a quantitative assessment of body morphometrics, functional assessments of pulmonary physiology, nasal nitric oxide measurement with subsequent detailed assessment of ciliary structure and motility in selected patients, quantitative immunoglobulins levels to screen for humoral immune defects, and selected genetic analysis of candidate alleles, such as CFTR and A1AT.
Genotype/phenotype correlations will be researched and possibly defined. Careful evaluation and characterization of these phenotypes will guide the genetic characterization of idiopathic bronchiectasis, and likely lead to an improved diagnostic approach. Identification of disease causing genes may provide new therapeutic targets.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Adults with idiopathic bronchiectasis |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with idiopathic bronchiectasis, with stratification by gender and by presence/absence of respiratory infection with nontuberculous mycobacteria (NTM)
Key inclusion criteria (5 listed)
- The criteria for participants to enter the study mandates that each patient have received a standard (current clinical practice) diagnostic evaluation that includes a CT scan of the chest to document bronchiectasis, prior to enrolling in the Consortium study. To enter this protocol, adults must have bronchiectasis and meet the following criteria:
- Males or females, age greater than or equal to18 years
- Chronic cough
- An available CT of the chest (on a CD) that shows evidence of dilated airways fulfilling radiographic criteria for bronchiectasis in more than one lobe
- Ability to provide informed consent, including HIPAA consent
Key exclusion criteria (5 listed)
- A participant should not be in the study if they have not had a standard clinical evaluation to rule out other potential causes of chronic sino-pulmonary disease.
- Known diagnosis of cystic fibrosis with classic clinical presentation and elevated sweat chloride levels and/or two known disease-causing CFTR mutations
- History of tuberculosis or other known explanation for bronchiectasis, such as alpha 1-antitrypsin deficiency (ZZ or ZS), confirmed or probable PCD, inflammatory bowel disease, rheumatoid arthritis, Sjogren s syndrome, allergic bronchopulmonary aspergillosis, or documented primary or acquired immunodeficiency
- Current smoker or > 10 pack-year history of tobacco use
- Prior solid organ transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical characteristics by gender and NTM
Time frame: 30 years
Clinical characteristics by gender and NTM status including body morphotypes, radiographic patterns, and respiratory flora
1 secondary outcome
Seek to define Genotype/phenotype
Time frame: 30 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Background: PubMed 8970383Wanner A, Salathe M, O'Riordan TG. Mucociliary clearance in the airways. Am J Respir Crit Care Med. 1996 Dec;154(6 Pt 1):1868-902. doi: 10.1164/ajrccm.154.6.8970383. No abstract available.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew J Lipton, M.D. principal investigator
National Heart, Lung, and Blood Institute (NHLBI)
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection and Bronchial Diseases, run by National Heart, Lung, and Blood Institute (NHLBI) at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical characteristics by gender and NTM (time frame: 30 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01264055, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.