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Mortality in Non-cystic Fibrosis Bronchiectasis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01792427
First Posted: February 15, 2013
Last Update Posted: February 20, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Lieven Dupont, Universitaire Ziekenhuizen Leuven
  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 Dr. Lieven Dupont, Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • overall survival [ Time Frame: 6 years 4 months ]

Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • Identify cause of death [ Time Frame: 6 years 4 months ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dr. Lieven Dupont, prof. dr., Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01792427     History of Changes
Other Study ID Numbers: B51060
B32220084152 ( Other Identifier: Belgium: Institutional Review Board )
First Submitted: February 13, 2013
First Posted: February 15, 2013
Last Update Posted: February 20, 2013
Last Verified: February 2013

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