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

NCT02332122 | Unknown

• 1 other identifier: S57222
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

COPD; Chronic Obstructive Pulmonary Disease; Aspergillus fumigatus; Bronchiectasis; Sensitization; Vitamin D

Outcome Measures

Primary Outcomes (1)

• Bronchiectasis

  immediate

Secondary Outcomes (3)

• Vitamin D

  immediate

• Prevalence of Aspergillus sensitization

  max 12weeks

• Prevalence of Aspergillus isolation in sputum

  max 12weeks

Study Arms (2)

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; Procedure: Skin prick test; Other: Questionnaires

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; Procedure: Skin prick test; Other: Questionnaires

Interventions

Sputum induction 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.

COPD patients with bronchiectasis; COPD patients without bronchiectasis

Skin prick test 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.

COPD patients with bronchiectasis; COPD patients without bronchiectasis

Questionnaires OTHER

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

COPD patients with bronchiectasis; COPD patients without bronchiectasis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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%

You may not qualify if:

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

Sponsors & Collaborators

• Wim Janssens: lead

Study Sites (1)

UZ Gasthuisberg

Leuven, Flanders, 3000, Belgium

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Sputum sample obtained through induction

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bronchiectasis

Interventions

Patch Tests; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases

Intervention Hierarchy (Ancestors)

Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Wim Janssens, MD. PhD

  KU Leuven - UZ Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie Everaerts, MD

CONTACT

016 37 94 92; Stephanie.Everaerts@kuleuven.be

Wim Janssens, MD. PhD

CONTACT

016 34 68 00; wim.janssens@uzleuven.be

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD. PhD

Study Record Dates

• First Submitted: January 5, 2015
• First Posted: January 6, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: May 1, 2017
• Last Updated: August 24, 2015

Record last verified: 2015-08

Locations

BE (1)