Mortality in Non-cystic Fibrosis Bronchiectasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Lieven Dupont, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01792427
First received: February 13, 2013
Last updated: February 18, 2013
Last verified: February 2013
  Purpose

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
Non-cystic Fibrosis Bronchiectasis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mortality in Non-cystic Fibrosis Bronchiectasis: a Long-term Cohort Analysis

Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • overall survival [ Time Frame: 6 years 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • risk factor identification for NCFB [ Time Frame: 6 years 4 months ] [ Designated as safety issue: No ]
    The investigators wanted to confirm the known risk factors such as age, gender, smoking history and Pseudomonas aeruginosa.


Other Outcome Measures:
  • Identify cause of death [ Time Frame: 6 years 4 months ] [ Designated as safety issue: No ]
    If death occurred, the patient file was reassessed to identify cause of death.

  • risk factor identification for the survival of NCFB [ Time Frame: 6 years 4 months ] [ Designated as safety issue: No ]
    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 .


Enrollment: 253
Study Start Date: June 2006
Study Completion Date: December 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

non-cystic fibrosis bronchiectasis

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01792427

Locations
Belgium
UZ Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Study Director: Pieter Goeminne, MD Universitaire Ziekenhuizen Leuven
  More Information

No publications provided

Responsible Party: Dr. Lieven Dupont, prof. dr., Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01792427     History of Changes
Other Study ID Numbers: B51060, B32220084152
Study First Received: February 13, 2013
Last Updated: February 18, 2013
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Bronchiectasis
Fibrosis
Bronchial Diseases
Respiratory Tract Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014