Mortality in Non-cystic Fibrosis Bronchiectasis

February 18, 2013 updated by: Dr. Lieven Dupont, Universitaire Ziekenhuizen KU Leuven

Mortality in Non-cystic Fibrosis Bronchiectasis: a Long-term Cohort Analysis

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.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

253

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • UZ Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

non-cystic fibrosis bronchiectasis

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 6 years 4 months
6 years 4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
risk factor identification for NCFB
Time Frame: 6 years 4 months
The investigators wanted to confirm the known risk factors such as age, gender, smoking history and Pseudomonas aeruginosa.
6 years 4 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify cause of death
Time Frame: 6 years 4 months
If death occurred, the patient file was reassessed to identify cause of death.
6 years 4 months
risk factor identification for the survival of NCFB
Time Frame: 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 .
6 years 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

February 13, 2013

First Submitted That Met QC Criteria

February 13, 2013

First Posted (Estimate)

February 15, 2013

Study Record Updates

Last Update Posted (Estimate)

February 20, 2013

Last Update Submitted That Met QC Criteria

February 18, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • B51060 (OTHER: Belgium: Institutional Review Board)
  • B32220084152 (Belgium: Institutional Review Board)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non-cystic Fibrosis Bronchiectasis

3
Subscribe