Detection of Aspergillus Fumigatus and Sensitization in COPD Patients With Bronchiectasis vs Without Bronchiectasis

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Procedure: Sputum induction; Procedure: Skin prick test; Other: Questionnaires

• Registration Number: NCT02332122
• Lead Sponsor: Wim Janssens

Brief Summary

A single center case-control study with 100 COPD patients will be organized to compare patients with and without bronchiectasis with regard to the presence of Aspergillus in sputum samples, Aspergillus sensitization and vitamin D. Induced sputum samples will be optimized for culture, Aspergillus galatomannan analysis and RT-PCR.

This study is part of a larger project in which we assume that chronic respiratory infection by Aspergillus fumigatus and the accompanying immune response play an important role in the development of bronchiectasis in COPD. We suspect that this mechanism is controlled by vitamin D and it fails by suppression of the vitamin D receptor by Aspergillus fumigatus.

The present study is designed by the Laboratory of pneumology and will be conducted in collaboration with the Laboratory of clinical bacteriology and mycology of the Catholic University of Leuven.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-05
• Study First Submitted QC: 2015-01-05
• Study First Posted: 2015-01-06
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-21
• Last Update Posted: 2015-08-24
• Primary Completion: 2016-12
• Study Completion: 2017-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Established diagnosis of COPD by medical doctor (based on clinical history or pulmonary function test)
• Smoking history of at least 10 pack-years
• CT Thorax available for assessment of bronchiectasis
• FEV1 >= 30%

Exclusion Criteria

• Mechanical or non-invasive ventilation
• Other main respiratory diagnosis other than COPD
• Active mycobacterial disease
• Immunosuppression other than steroids
• Active cancer treatment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COPD patients without bronchiectasis	Skin prick test	All patients will receive standard therapy for AECOPD. Additional for this study are: Sputum induction, Skin prick test, Questionnaires
COPD patients without bronchiectasis	Questionnaires	All patients will receive standard therapy for AECOPD. Additional for this study are: Sputum induction, Skin prick test, Questionnaires
COPD patients with bronchiectasis	Sputum induction	All patients will receive standard therapy for AECOPD. Additional for this study are: Sputum induction, Skin prick test, Questionnaires
COPD patients with bronchiectasis	Skin prick test	All patients will receive standard therapy for AECOPD. Additional for this study are: Sputum induction, Skin prick test, Questionnaires
COPD patients with bronchiectasis	Questionnaires	All patients will receive standard therapy for AECOPD. Additional for this study are: Sputum induction, Skin prick test, Questionnaires
COPD patients without bronchiectasis	Sputum induction	All patients will receive standard therapy for AECOPD. Additional for this study are: Sputum induction, Skin prick test, Questionnaires

Primary Outcome Measures

Name	Time	Method
Bronchiectasis	immediate

Secondary Outcome Measures

Name	Time	Method
Vitamin D	immediate
Prevalence of Aspergillus sensitization	max 12weeks
Prevalence of Aspergillus isolation in sputum	max 12weeks

Trial Locations

Locations (1)

UZ Gasthuisberg; 🇧🇪 Leuven, Vlaanderen, Belgium