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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01792427
Other study ID # B51060
Secondary ID B32220084152
Status Completed
Phase N/A
First received February 13, 2013
Last updated February 18, 2013
Start date June 2006
Est. completion date December 2012

Study information

Verified date February 2013
Source Universitaire Ziekenhuizen Leuven
Contact n/a
Is FDA regulated No
Health authority Belgium: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 253
Est. completion date December 2012
Est. primary completion date October 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Belgium UZ Leuven Leuven Vlaams-Brabant

Sponsors (1)

Lead Sponsor Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Other Identify cause of death If death occurred, the patient file was reassessed to identify cause of death. 6 years 4 months No
Other risk factor identification for the survival of NCFB 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 No
Primary overall survival 6 years 4 months No
Secondary risk factor identification for NCFB The investigators wanted to confirm the known risk factors such as age, gender, smoking history and Pseudomonas aeruginosa. 6 years 4 months No
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