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

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ClinicalTrials.gov Identifier: NCT02332122
Recruitment Status : Unknown
Verified August 2015 by Wim Janssens, KU Leuven.
Recruitment status was:  Recruiting
First Posted : January 6, 2015
Last Update Posted : August 24, 2015
Sponsor:
Information provided by (Responsible Party):
Wim Janssens, KU Leuven

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.


Condition or disease Intervention/treatment
Chronic Obstructive Pulmonary Disease Procedure: Sputum induction Procedure: Skin prick test Other: Questionnaires

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Detection of Aspergillus Fumigatus and Sensitization in COPD Patients With Bronchiectasis vs COPD Patients Without Bronchiectasis
Study Start Date : January 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
COPD patients with bronchiectasis

All patients will receive standard therapy for AECOPD.

Additional for this study are:

Sputum induction, Skin prick test, Questionnaires

Procedure: 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.

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.

Other: Questionnaires
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

Procedure: 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.

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.

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




Primary Outcome Measures :
  1. Bronchiectasis [ Time Frame: immediate ]

Secondary Outcome Measures :
  1. Vitamin D [ Time Frame: immediate ]
  2. Prevalence of Aspergillus sensitization [ Time Frame: max 12weeks ]
  3. Prevalence of Aspergillus isolation in sputum [ Time Frame: max 12weeks ]

Biospecimen Retention:   Samples With DNA
Sputum sample obtained through induction


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who present in the emergency department with an acute COPD exacerbation (as defined by GOLD executive summary) requiring hospitalization are eligible for this study. Patients should have an established diagnosis of COPD (based on clinical history or pulmonary function test). They will be recruited during their hospital stay in the University Hospital of Leuven.

Additionally, we will include 20 patients with COPD (10 with bronchiectasis versus 10 without) in stable state during their outpatient visits.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02332122


Contacts
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Contact: Stephanie Everaerts, MD 016 37 94 92 ext 0032 Stephanie.Everaerts@kuleuven.be
Contact: Wim Janssens, MD. PhD 016 34 68 00 ext 0032 wim.janssens@uzleuven.be

Locations
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Belgium
UZ Gasthuisberg Recruiting
Leuven, Vlaanderen, Belgium, 3000
Contact: Stephanie Everaerts, MD.    016 37 94 92 ext 0032    Stephanie.Everaerts@kuleuven.be   
Principal Investigator: Wim Janssens, MD. PhD.         
Sponsors and Collaborators
Wim Janssens
Investigators
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Principal Investigator: Wim Janssens, MD. PhD KU Leuven - UZ Leuven
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Responsible Party: Wim Janssens, MD. PhD, KU Leuven
ClinicalTrials.gov Identifier: NCT02332122    
Other Study ID Numbers: S57222
First Posted: January 6, 2015    Key Record Dates
Last Update Posted: August 24, 2015
Last Verified: August 2015
Keywords provided by Wim Janssens, KU Leuven:
COPD
Chronic Obstructive Pulmonary Disease
Aspergillus fumigatus
Bronchiectasis
Sensitization
Vitamin D
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Bronchiectasis
Respiratory Tract Diseases
Bronchial Diseases