AsthmaNCT00773487
Influence of Diesel Exhaust Particles (DEP) With and Without Organic Compounds on the Allergic Inflammation in Asthmatic Subjects
A study testing Bonchoscopy in people with Asthma, run by Fraunhofer-Institute of Toxicology and Experimental Medicine at 1 site in Germany.
Trial summary
The primary objective of this study is to elucidate the effects of Diesel particles on the allergic inflammation in the airways of asthmatic patients. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Asthma
- What is being tested?
- Bonchoscopy
- How many people
- 15 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2008to Jul 2009
- Phase
- Interventional
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Able and willing to give written informed consent
- Physician diagnosis of mild intermittent or mild persistent asthma according to GINA guidelines {Bateman, 2008 34 /id}
- Age 18-55 years
- Nonsmokers with a history of less than 1 packyear having been nonsmokers for at least the last five years
- FEV1 >= 80% of predicted, FEV1/FVC >= 70 %
- Positive skin prick test for grass mix or D. pteronyssinus at or within 12 months prior to the screening visit
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- Positive response to inhaled methacholine (<= 8mg/ml)
- Positive response to an incremental inhaled allergen challenge with house dust mite allergen or grass pollen allergen
- Available to complete all study measurements
- Women will be considered for inclusion if they are:
- Not pregnant, as confirmed by pregnancy test, and not nursing
- Of non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is pre-menarchial or post-menopausal, with documented proof of hysterectomy or tubal ligation, or meet clinical criteria for menopause and has been amenorrhoeic for more than 1 year prior to the screening visit)
- Of childbearing potential and using a highly effective method of contraception during the entire study (vasectomised partner, sexual abstinence - the lifestyle of the female should be such that there is complete abstinence from intercourse from two weeks prior to the study until at least 72 hours after the end of the study -, implants, injectables, combined oral contraceptives, hormonal IUDs)
Who cannot join
- History of upper or lower respiratory tract infection four weeks prior to the informed consent visit
- Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, psychiatric disease, endocrine disease, infectious disease, inflammatory disease, or pulmonary disease (including but not confined to chronic bronchitis, emphysema, tuberculosis, bronchiectasis or cystic fibrosis).
- Clinically significant pathological findings in safety laboratory tests
- Regular intake of any medication other than short acting inhaled beta agonists, paracetamol for pain relief, birth control medication, hormonal replacement therapy, dietary and vitamin supplements
- Specific Immunotherapy (SIT) within two years prior to the study
- Use of anti-inflammatory medication including systemic or inhaled corticosteroid within the last four weeks
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- Any history of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures.
- Suspected hypersensitivity to any ingredients of the medication in line with bronchoscopy (bronchodilators, sedatives and local anesthetics)
- Conditions or factors, which would make the subject unlikely to be able to undergo bronchoscopy or incremental allergen challenge
- History of drug or alcohol abuse
- Suspected inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study.
- Participation in a clinical trial 30 days prior to enrolment
- Segmental allergen challenge 3 months prior to treatment
- Risk of non-compliance with study procedures
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this study is to elucidate the effects of Diesel particles on the allergic inflammation in the airways of asthmatic patients.
Read the detailed description
A first bronchoscopy will be performed with a baseline bronchoalveolar lavage (BAL) and epithelial brushes followed by a segmental instillation of allergen (grass mix or house dust mite) alone, in combination with Diesel particles, further in combination with Diesel particles without organic compounds and saline as control into four different lung segments. After 24 hours, during a second bronchoscopy, BAL samples will be collected in these challenged segments in order to obtain cells and lavage fluid for cell biological and immunological analysis.
- Conditions
- Asthma
- Being tested
- Bonchoscopy
- Keywords
- Asthma GINA 1, Mild intermittant asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BonchoscopyOther
Segmental instillation of allergen/Diesel particles; bronchoalveolar lavage
What is being measured
The primary outcome is the main question the study is designed to answer.
difference of the total number of eosinophils resulting in the comparison of allergic versus allergic inflammation in combination with Diesel particles with and without the organic fraction.
Measured: 24 post allergen challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fraunhofer-Institute of Toxicology and Experimental Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Investigators
- Norber Krug, MD, Principal investigator, Fraunhofer ITEM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00773487
- Sponsor's protocol ID
- 08/06 DEP-SFB
- Status last verified
- Jul 2009
- First submitted
- 14 Oct 2008
- Last updated
- 28 Jul 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Diesel Exhaust Particles (DEP) With and Without Organic Compounds on the Allergic Inflammation in Asthmatic Subjects
- ClinicalTrials.gov ID
- NCT00773487
- Acronym / sponsor ID
- 08/06 DEP-SFB
- Conditions
- Asthma
- Keywords
- Asthma GINA 1, Mild intermittant asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Fraunhofer-Institute of Toxicology and Experimental MedicineUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- Oct 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 16 Oct 2008 (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.
The primary objective of this study is to elucidate the effects of Diesel particles on the allergic inflammation in the airways of asthmatic patients.
Detailed description
A first bronchoscopy will be performed with a baseline bronchoalveolar lavage (BAL) and epithelial brushes followed by a segmental instillation of allergen (grass mix or house dust mite) alone, in combination with Diesel particles, further in combination with Diesel particles without organic compounds and saline as control into four different lung segments. After 24 hours, during a second bronchoscopy, BAL samples will be collected in these challenged segments in order to obtain cells and lavage fluid for cell biological and immunological analysis.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Able and willing to give written informed consent
- Physician diagnosis of mild intermittent or mild persistent asthma according to GINA guidelines {Bateman, 2008 34 /id}
- Age 18-55 years
- Nonsmokers with a history of less than 1 packyear having been nonsmokers for at least the last five years
- FEV1 >= 80% of predicted, FEV1/FVC >= 70 %
Key exclusion criteria (14 listed)
- History of upper or lower respiratory tract infection four weeks prior to the informed consent visit
- Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, psychiatric disease, endocrine disease, infectious disease, inflammatory disease, or pulmonary disease (including but not confined to chronic bronchitis, emphysema, tuberculosis, bronchiectasis or cystic fibrosis).
- Clinically significant pathological findings in safety laboratory tests
- Regular intake of any medication other than short acting inhaled beta agonists, paracetamol for pain relief, birth control medication, hormonal replacement therapy, dietary and vitamin supplements
- Specific Immunotherapy (SIT) within two years prior to the study
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 |
|---|---|---|
| BonchoscopySegmental instillation of allergen/Diesel particles; bronchoalveolar lavage | Other | – |
Primary outcome
difference of the total number of eosinophils resulting in the comparison of allergic versus allergic inflammation in combination with Diesel particles with and without the organic fraction.
Time frame: 24 post allergen challenge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2009.
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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.
Norber Krug, MD principal investigator
Fraunhofer ITEM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bonchoscopy in people with Asthma, run by Fraunhofer-Institute of Toxicology and Experimental Medicine at 1 site in Germany.
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 13 inclusion and 14 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: finished, as of the sponsor's last update on 28 Jul 2009. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference of the total number of eosinophils resulting in the comparison of allergic versus allergic inflammation in combination with Diesel particles with and without the organic fraction. (time frame: 24 post allergen challenge). 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 28 Jul 2009.