- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01792427
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
Conditions
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
-
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Vlaams-Brabant
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Leuven, Vlaams-Brabant, Belgium, 3000
- UZ Leuven
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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
Additional Relevant MeSH Terms
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.
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The University of Hong KongCompleted
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