Non-CF BronchiectasisNCT01822834
Bronchiectasis and NTM Research Registry
An observational study of Non-CF Bronchiectasis and Nontuberculosis Mycobacteria (NTM), run by COPD Foundation at 1 site in United States.
Trial summary
The Bronchiectasis Research Registry is a consolidated database of non-cystic fibrosis (non-CF) Bronchiectasis and Nontuberculosis Mycobacteria (NTM) patients from multiple clinical institutions. Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-CF Bronchiectasis, Nontuberculosis Mycobacteria (NTM)
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Dec 2050
- How long will I take part?
- 20 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients over the age of 18 with non-CF Bronchiectasis and/or Nontuberculosis Mycobacteria (NTM).
Who may be able to join
- Over the age of 18
- non-CF Bronchiectasis
- Nontuberculosis Mycobacteria (NTM)
Who cannot join
- Under the age of 18
- CF Bronchiectasis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Delia Prieto contact
United States1 site, 1 recruiting
- Recruiting
COPD Foundation
Washington D.C., District of Columbia
About this study
The Bronchiectasis Research Registry is a consolidated database of non-cystic fibrosis (non-CF) Bronchiectasis and Nontuberculosis Mycobacteria (NTM) patients from multiple clinical institutions.
Read the detailed description
The Bronchiectasis Research Registry is a consolidated database of non-cystic fibrosis (non-CF) Bronchiectasis and Nontuberculosis Mycobacteria (NTM) patients from multiple clinical institutions. The goal of the Bronchiectasis Research Registry is to support collaborative research and assist in the planning of multi-center clinical trials for the treatment of NTM and non-CF Bronchiectasis, a progressive, non-curable disease of the lungs, which afflicts thousands of patients. The Registry will also be used to provide better insight into the study of the different types of Bronchiectasis, as well as the pathophysiology of the disorder. In 2012, in collaboration with NTM Info and Research, Inc (NTMir) and the consortium members, the COPD Foundation expanded the Bronchiectasis Research Registry to enroll patients with "non tuberculous mycobacteria (NTM) only". Prior to this time, the registry included individuals with Bronchiectasis, with or without NTM.
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 |
|---|---|---|
| Non-CF Bronchiectasis Patients with or without NTM | Patients over the age of 18 with non-CF Bronchiectasis with or without Nontuberculosis Mycobacteria (NTM). | |
| Nontuberculosis Mycobacteria (NTM) | Patients over the age of 18 with Nontuberculosis Mycobacteria (NTM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Recruitment and Data analysis
The COPD Foundation expects to assist at least 4 researchers (with patient recruitment and/or data analysis) annually.
Measured: December 2050
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2013 (estimated)
- Study startJan 2008
- Primary completionDec 2050 (estimated)
- Study completionDec 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-CF BronchiectasisStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- COPD Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01822834
- Sponsor's protocol ID
- BRR
- Status last verified
- Mar 2022
- First submitted
- 28 Mar 2013
- Last updated
- 22 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bronchiectasis and NTM Research Registry
- ClinicalTrials.gov ID
- NCT01822834
- Acronym / sponsor ID
- BRR
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- COPD FoundationUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2050 (estimated)
- Study completion
- Dec 2050 (estimated)
- First posted
- 2 Apr 2013 (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.
The Bronchiectasis Research Registry is a consolidated database of non-cystic fibrosis (non-CF) Bronchiectasis and Nontuberculosis Mycobacteria (NTM) patients from multiple clinical institutions.
Detailed description
The Bronchiectasis Research Registry is a consolidated database of non-cystic fibrosis (non-CF) Bronchiectasis and Nontuberculosis Mycobacteria (NTM) patients from multiple clinical institutions. The goal of the Bronchiectasis Research Registry is to support collaborative research and assist in the planning of multi-center clinical trials for the treatment of NTM and non-CF Bronchiectasis, a progressive, non-curable disease of the lungs, which afflicts thousands of patients. The Registry will also be used to provide better insight into the study of the different types of Bronchiectasis, as well as the pathophysiology of the disorder. In 2012, in collaboration with NTM Info and Research, Inc (NTMir) and the consortium members, the COPD Foundation expanded the Bronchiectasis Research Registry to enroll patients with "non tuberculous mycobacteria (NTM) only". Prior to this time, the registry included individuals with Bronchiectasis, with or without NTM.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-CF Bronchiectasis Patients with or without NTM | – | –Patients over the age of 18 with non-CF Bronchiectasis with or without Nontuberculosis Mycobacteria (NTM). |
| Nontuberculosis Mycobacteria (NTM) | – | –Patients over the age of 18 with Nontuberculosis Mycobacteria (NTM) |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over the age of 18 with non-CF Bronchiectasis and/or Nontuberculosis Mycobacteria (NTM).
Key inclusion criteria (3 listed)
- Over the age of 18
- non-CF Bronchiectasis
- Nontuberculosis Mycobacteria (NTM)
Key exclusion criteria (2 listed)
- Under the age of 18
- CF Bronchiectasis
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
Patient Recruitment and Data analysis
Time frame: December 2050
The COPD Foundation expects to assist at least 4 researchers (with patient recruitment and/or data analysis) annually.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
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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.
Delia Prieto contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-CF Bronchiectasis and Nontuberculosis Mycobacteria (NTM), run by COPD Foundation at 1 site in United States.
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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Delia Prieto (1-866-731-2673 ext. 272), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Recruitment and Data analysis (time frame: December 2050). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Mar 2022.