Clincosm LogoSign in Get a demo

Mortality in Non-cystic Fibrosis Bronchiectasis

Sponsor
Universitaire Ziekenhuizen Leuven (Other)
Overall Status
Completed
CT.gov ID
NCT01792427
Collaborator
(none)
253
Enrollment
1
Location
78
Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In this study we analyzed the overall survival for all newly diagnosed patients with non-cystic fibrosis bronchiectasis from June 2006 onwards. The investigators wanted to confirm the known risk factors such as age, gender, smoking history and Pseudomonas aeruginosa and evaluate the impact on survival of etiology, number of different bacteriological species in retrospective and prospective sputa, azithromycin use and presence/development of pulmonary hypertension.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    253 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Mortality in Non-cystic Fibrosis Bronchiectasis: a Long-term Cohort Analysis
    Study Start Date :
    Jun 1, 2006
    Actual Primary Completion Date :
    Oct 1, 2012
    Actual Study Completion Date :
    Dec 1, 2012

    Outcome Measures

    Primary Outcome Measures

    1. overall survival [6 years 4 months]

    Secondary Outcome Measures

    1. risk factor identification for NCFB [6 years 4 months]

      The investigators wanted to confirm the known risk factors such as age, gender, smoking history and Pseudomonas aeruginosa.

    Other Outcome Measures

    1. Identify cause of death [6 years 4 months]

      If death occurred, the patient file was reassessed to identify cause of death.

    2. risk factor identification for the survival of NCFB [6 years 4 months]

      The investigators will evaluate the impact of etiology, number of different bacteriological species in retrospective and prospective sputa, azithromycin use and presence/development of pulmonary hypertension on survival .

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients with clinically significant and radiologically proven bronchiectasis

    • Chest CT scan confirming the presence of bronchiectatic lesions and had symptoms of chronic productive cough

    • Bronchiectasis was deemed to be present if there was one or more of the following criteria: a bronchoarterial ratio greater than 1, lack of tapering of the bronchi and visualization of bronchi within 1 cm of costal or paravertebral pleura or abutting the mediastinal pleura

    Exclusion Criteria:

    • diagnosis of cystic fibrosis

    • underlying tumoral problem causing the bronchiectatic lesions (postradiotherapy, secondary immunodeficiency due to chemotherapy or postinfectious due to tumoral obstruction)

    • patients with asymptomatic traction bronchiectasis caused by interstitial lung disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UZ Leuven Leuven Vlaams-Brabant Belgium 3000

    Sponsors and Collaborators

    • Universitaire Ziekenhuizen Leuven

    Investigators

    • Study Director: Pieter Goeminne, MD, Universitaire Ziekenhuizen Leuven

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Lieven Dupont, prof. dr., Universitaire Ziekenhuizen Leuven
    ClinicalTrials.gov Identifier:
    NCT01792427
    Other Study ID Numbers:
    • B51060
    • B32220084152
    First Posted:
    Feb 15, 2013
    Last Update Posted:
    Feb 20, 2013
    Last Verified:
    Feb 1, 2013
    Additional relevant MeSH terms:
    Bronchiectasis
    Fibrosis

    Study Results

    No Results Posted as of Feb 20, 2013