BronchiectasisNCT06144996
Development of a Canadian Bronchiectasis and NTM Database
An observational study of Bronchiectasis and Non-Tuberculous Mycobacterial Pneumonia, run by University of Calgary at 1 site in Canada.
Trial summary
The investigators aim to develop a comprehensive patient registry of patients with non-CF bronchiectasis and/or Nontuberculosis Mycobacteria (NTM) Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Bronchiectasis, Non-Tuberculous Mycobacterial Pneumonia
- How many people
- 2,000 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2023to Jan 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.
Canada1 site, 1 recruiting
- Recruiting
University of Calgary
Calgary, Alberta, T2N4N1
Christina Thornton, MD PhD, 403-210-8945, ceshaghu@ucalgary.ca
Julie Jarand, MD, 403-943-2502
About this study
The investigators aim to develop a comprehensive patient registry of patients with non-CF bronchiectasis and/or Nontuberculosis Mycobacteria (NTM)
Read the detailed description
The investigators aim to develop a comprehensive patient registry of patients with non-CF bronchiectasis and/or Nontuberculosis Mycobacteria (NTM). This will entail inclusion of adults (age >18 years) with a diagnosis of these conditions to be entered with complete clinical data and quality of life assessments entered into a patient registry.
- Medical subject headings
- 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 |
|---|---|---|
| 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 for NTM and Bronchiectasis
Descriptive analysis of demographics and clinical parameters and epidemiological evaluation of No. of hospitalizations, No. of exacerbations.
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 posted22 Nov 2023
- Study start1 Jan 2023
- Primary completionJan 2050 (estimated)
- Study completionJan 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiectasisStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Insmed Incorporated, Trudell Medical International
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06144996
- Sponsor's protocol ID
- REB21-1131
- Status last verified
- Jun 2023
- First submitted
- 28 Jun 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Canadian Bronchiectasis and NTM Database
- ClinicalTrials.gov ID
- NCT06144996
- Acronym / sponsor ID
- REB21-1131
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Insmed Incorporated, Trudell Medical International
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- Jan 2050 (estimated)
- Study completion
- Jan 2050 (estimated)
- First posted
- 22 Nov 2023 (actual)
- 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 investigators aim to develop a comprehensive patient registry of patients with non-CF bronchiectasis and/or Nontuberculosis Mycobacteria (NTM)
Detailed description
The investigators aim to develop a comprehensive patient registry of patients with non-CF bronchiectasis and/or Nontuberculosis Mycobacteria (NTM). This will entail inclusion of adults (age >18 years) with a diagnosis of these conditions to be entered with complete clinical data and quality of life assessments entered into a patient registry.
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 for NTM and Bronchiectasis
Time frame: December 2050
Descriptive analysis of demographics and clinical parameters and epidemiological evaluation of No. of hospitalizations, No. of exacerbations.
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 Nov 2023.
- Individual participant dataSharing planned: No
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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.
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 Bronchiectasis and Non-Tuberculous Mycobacterial Pneumonia, run by University of Calgary at 1 site in Canada.
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 Nov 2023. 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 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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Recruitment and Data analysis for NTM and Bronchiectasis (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 Nov 2023; AzTrials last refreshed its copy on 3 Nov 2026.