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

NCT ID: NCT02332122

Last Updated: 2015-08-24

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2017-05-31

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

COPD patients with bronchiectasis

All patients will receive standard therapy for AECOPD.

Additional for this study are:

Sputum induction, Skin prick test, Questionnaires

Sputum induction

Intervention Type: PROCEDURE

Patients will have to puff 200µg of salbutamol (metered-dose inhaler with spacer device). After 10 minutes FEV1 will be measured with MIR spirobank. If FEV1 is \>= 30% we can safely proceed with sputum induction. An ultrasonic nebulizer will be used to induce sputum. 4% sodiumchloride will be inhaled. Induction will be performed at 5-min intervals until a sample of good quality is obtained. Sodiumchloride of 5% will be used if no good sample is obtained after two intervals with the 4% solution. Maximal time of induction will be 20 minutes. Subjects will spit saliva into one container and rinse the mouth thoroughly with water before coughing sputum into another sterile container. Samples will be refrigerated at 4°C and processed within 24 hours of collection.

Skin prick test

Intervention Type: PROCEDURE

Skin Prick Test is a reliable method to diagnose IgE-mediated allergic disease. It is minimally invasive and results are immediately available. Interpretation utilizes the presence and degree of cutaneous reactivity as a surrogate marker for sensitization. A positive control, a negative control and Aspergillus fumigatus will be tested. Location will be Protocol version 1 3/11/2014 marked on the volar aspect of the forearm and drops of each solution will be placed (\>= 2cm between drops). A single-head metal lancet will be pressed through the drop of allergen extract and held against the skin for at least 1 second. A new lancet will be utilized for each drop. A wheal diameter of \>= 3mm is a positive result.

Questionnaires

Intervention Type: OTHER

MRC: Medical Research Council Scale CAT: COPD Assessment Test SGRQ: Saint George's respiratory questionnaire

COPD patients without bronchiectasis

All patients will receive standard therapy for AECOPD.

Additional for this study are:

Sputum induction, Skin prick test, Questionnaires

Sputum induction

Intervention Type: PROCEDURE

Patients will have to puff 200µg of salbutamol (metered-dose inhaler with spacer device). After 10 minutes FEV1 will be measured with MIR spirobank. If FEV1 is \>= 30% we can safely proceed with sputum induction. An ultrasonic nebulizer will be used to induce sputum. 4% sodiumchloride will be inhaled. Induction will be performed at 5-min intervals until a sample of good quality is obtained. Sodiumchloride of 5% will be used if no good sample is obtained after two intervals with the 4% solution. Maximal time of induction will be 20 minutes. Subjects will spit saliva into one container and rinse the mouth thoroughly with water before coughing sputum into another sterile container. Samples will be refrigerated at 4°C and processed within 24 hours of collection.

Skin prick test

Intervention Type: PROCEDURE

Skin Prick Test is a reliable method to diagnose IgE-mediated allergic disease. It is minimally invasive and results are immediately available. Interpretation utilizes the presence and degree of cutaneous reactivity as a surrogate marker for sensitization. A positive control, a negative control and Aspergillus fumigatus will be tested. Location will be Protocol version 1 3/11/2014 marked on the volar aspect of the forearm and drops of each solution will be placed (\>= 2cm between drops). A single-head metal lancet will be pressed through the drop of allergen extract and held against the skin for at least 1 second. A new lancet will be utilized for each drop. A wheal diameter of \>= 3mm is a positive result.

Questionnaires

Intervention Type: OTHER

MRC: Medical Research Council Scale CAT: COPD Assessment Test SGRQ: Saint George's respiratory questionnaire

Interventions

Sputum induction

Patients will have to puff 200µg of salbutamol (metered-dose inhaler with spacer device). After 10 minutes FEV1 will be measured with MIR spirobank. If FEV1 is \>= 30% we can safely proceed with sputum induction. An ultrasonic nebulizer will be used to induce sputum. 4% sodiumchloride will be inhaled. Induction will be performed at 5-min intervals until a sample of good quality is obtained. Sodiumchloride of 5% will be used if no good sample is obtained after two intervals with the 4% solution. Maximal time of induction will be 20 minutes. Subjects will spit saliva into one container and rinse the mouth thoroughly with water before coughing sputum into another sterile container. Samples will be refrigerated at 4°C and processed within 24 hours of collection.

Intervention Type: PROCEDURE

Skin prick test

Skin Prick Test is a reliable method to diagnose IgE-mediated allergic disease. It is minimally invasive and results are immediately available. Interpretation utilizes the presence and degree of cutaneous reactivity as a surrogate marker for sensitization. A positive control, a negative control and Aspergillus fumigatus will be tested. Location will be Protocol version 1 3/11/2014 marked on the volar aspect of the forearm and drops of each solution will be placed (\>= 2cm between drops). A single-head metal lancet will be pressed through the drop of allergen extract and held against the skin for at least 1 second. A new lancet will be utilized for each drop. A wheal diameter of \>= 3mm is a positive result.

Intervention Type: PROCEDURE

Questionnaires

MRC: Medical Research Council Scale CAT: COPD Assessment Test SGRQ: Saint George's respiratory questionnaire

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wim Janssens

OTHER

Sponsor Role: lead

Responsible Party

Wim Janssens

MD. PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Wim Janssens, MD. PhD

Role: PRINCIPAL_INVESTIGATOR

KU Leuven - UZ Leuven

Locations

UZ Gasthuisberg

Leuven, Flanders, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Stephanie Everaerts, MD

Role: CONTACT

Stephanie.Everaerts@kuleuven.be

016 37 94 92 ext. 0032

Wim Janssens, MD. PhD

Role: CONTACT

wim.janssens@uzleuven.be

016 34 68 00 ext. 0032

Facility Contacts

Stephanie Everaerts, MD.

Role: primary

Stephanie.Everaerts@kuleuven.be

016 37 94 92 ext. 0032

Other Identifiers

S57222

Identifier Type: -

Identifier Source: org_study_id