Mortality in Non-cystic Fibrosis Bronchiectasis

Non-cystic Fibrosis Bronchiectasis Clinical Trial

Official title:

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

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

• Bronchiectasis
• Fibrosis
• Non-cystic Fibrosis Bronchiectasis

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