Mortality in Non-cystic Fibrosis Bronchiectasis
This study has been completed.
Sponsor:
Universitaire Ziekenhuizen Leuven
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
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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 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 May 16, 2013