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Development of a Canadian Bronchiectasis and NTM Database

Sponsor
University of Calgary (Other)
Overall Status
Recruiting
CT.gov ID
NCT06144996
Collaborator
Insmed Incorporated (Industry), Trudell Medical (Other)
2,000
Enrollment
1
Location
324
Anticipated Duration (Months)
6.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators aim to develop a comprehensive patient registry of patients with non-CF bronchiectasis and/or Nontuberculosis Mycobacteria (NTM)

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    2000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Development of a Canadian Bronchiectasis and NTM Database
    Actual Study Start Date :
    Jan 1, 2023
    Anticipated Primary Completion Date :
    Jan 1, 2050
    Anticipated Study Completion Date :
    Jan 1, 2050

    Arms and Interventions

    Arm Intervention/Treatment
    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)

    Outcome Measures

    Primary Outcome Measures

    1. Patient Recruitment and Data analysis for NTM and Bronchiectasis [December 2050]

      Descriptive analysis of demographics and clinical parameters and epidemiological evaluation of No. of hospitalizations, No. of exacerbations.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 120 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Over the age of 18

    • Non-CF Bronchiectasis

    • Nontuberculosis Mycobacteria (NTM)

    Exclusion Criteria:

    • Under the age of 18

    • CF bronchiectasis

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Calgary Calgary Alberta Canada T2N4N1

    Sponsors and Collaborators

    • University of Calgary
    • Insmed Incorporated
    • Trudell Medical

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Calgary
    ClinicalTrials.gov Identifier:
    NCT06144996
    Other Study ID Numbers:
    • REB21-1131
    First Posted:
    Nov 22, 2023
    Last Update Posted:
    Nov 22, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Bronchiectasis

    Study Results

    No Results Posted as of Nov 22, 2023