Chronic Obstructive Pulmonary DiseaseNCT02332122
Detection of Aspergillus Fumigatus and Sensitization in COPD Patients With Bronchiectasis vs Without Bronchiectasis
An observational study of Chronic Obstructive Pulmonary Disease, run by Wim Janssens at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Sputum induction, Skin prick test and Questionnaires
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2015to May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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%
Who cannot join
- Mechanical or non-invasive ventilation
- Other main respiratory diagnosis other than COPD
- Active mycobacterial disease
- Immunosuppression other than steroids
- Active cancer treatment
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
UZ Gasthuisberg
Leuven, Flanders, 3000
Stephanie Everaerts, MD., 016 37 94 92 ext. 0032, Stephanie.Everaerts@kuleuven.be
Wim Janssens, MD. PhD.
About this study
Official title: Detection of Aspergillus Fumigatus and Sensitization in COPD Patients With Bronchiectasis vs COPD Patients Without Bronchiectasis
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
- Being tested
- Sputum induction, Skin prick test, Questionnaires
- Keywords
- COPD, Chronic Obstructive Pulmonary Disease, Aspergillus fumigatus, Bronchiectasis, Sensitization, Vitamin D
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sputum inductionProcedure or surgery
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 testProcedure or surgery
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.
QuestionnairesOther
MRC: Medical Research Council Scale CAT: COPD Assessment Test SGRQ: Saint George's respiratory questionnaire
| Study group | Role | What they receive |
|---|---|---|
| COPD patients with bronchiectasis | All patients will receive standard therapy for AECOPD.
Additional for this study are:
Sputum induction, Skin prick test, Questionnaires Receives: 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 Receives: Procedure: Sputum induction; Procedure: Skin prick test; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bronchiectasis
Measured: immediate
Secondary outcomes (3)
Vitamin D
Measured: immediate
Prevalence of Aspergillus sensitization
Measured: max 12weeks
Prevalence of Aspergillus isolation in sputum
Measured: max 12weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2016 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wim Janssens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wim Janssens, KU Leuven
- Investigators
- Wim Janssens, MD. PhD, Principal investigator, KU Leuven - UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02332122
- Sponsor's protocol ID
- S57222
- Status last verified
- Aug 2015
- First submitted
- 5 Jan 2015
- Last updated
- 24 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Aspergillus Fumigatus and Sensitization in COPD Patients With Bronchiectasis vs COPD Patients Without Bronchiectasis
- ClinicalTrials.gov ID
- NCT02332122
- Acronym / sponsor ID
- S57222
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Chronic Obstructive Pulmonary Disease, Aspergillus fumigatus, Bronchiectasis, Sensitization, Vitamin D
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Wim JanssensUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 6 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD patients with bronchiectasis | – | Procedure: Sputum induction, Procedure: Skin prick test, Other: QuestionnairesAll patients will receive standard therapy for AECOPD. Additional for this study are: Sputum induction, Skin prick test, Questionnaires |
| COPD patients without bronchiectasis | – | Procedure: Sputum induction, Procedure: Skin prick test, Other: QuestionnairesAll patients will receive standard therapy for AECOPD. Additional for this study are: Sputum induction, Skin prick test, Questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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%
Key exclusion criteria (5 listed)
- Mechanical or non-invasive ventilation
- Other main respiratory diagnosis other than COPD
- Active mycobacterial disease
- Immunosuppression other than steroids
- Active cancer treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sputum inductionPatients 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 or surgery | COPD patients with bronchiectasis, COPD patients without bronchiectasis |
| Skin prick testSkin 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. | Procedure or surgery | COPD patients with bronchiectasis, COPD patients without bronchiectasis |
| QuestionnairesMRC: Medical Research Council Scale CAT: COPD Assessment Test SGRQ: Saint George's respiratory questionnaire | Other | COPD patients with bronchiectasis, COPD patients without bronchiectasis |
Primary outcome
Bronchiectasis
Time frame: immediate
3 secondary outcomes
Vitamin D
Time frame: immediate
Prevalence of Aspergillus sensitization
Time frame: max 12weeks
Prevalence of Aspergillus isolation in sputum
Time frame: max 12weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wim Janssens, MD. PhD principal investigator
KU Leuven - UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by Wim Janssens at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Everaerts, MD (016 37 94 92 ext. 0032, Stephanie.Everaerts@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bronchiectasis (time frame: immediate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2015.