AsthmaNCT00527462
Study to Explore the Effects of Two Hour Inhalation of Ultrafine Carbon Black Particles on Airway Inflammation in Asthmatics
A study testing Bronchoscopy and Exposure to ultrafine carbon black particles in people with Asthma, run by Fraunhofer-Institute of Toxicology and Experimental Medicine at 1 site in Germany.
Trial summary
The aim of the study is to test the hypothesis that the allergic airway inflammation in asthmatic patients will be enhanced after exposure to ultrafine particles (UFP). In order to test this in a controlled study, the researchers combine controlled exposure to carbon black model UFP with the well-established model of… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Asthma
- What is being tested?
- Bronchoscopy and Exposure to ultrafine carbon black particles
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2007to Apr 2008
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female subjects, aged 18-45 years.
- Women will be considered for inclusion if they are:
- Not pregnant, as confirmed by a pregnancy test and not nursing.
- Not of child-bearing capacity (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 meets clinical criteria for menopause and has been amenorrheal for more than 1 year prior to the screening visit).
- Of child-bearing capacity 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 two weeks prior to the first dose of study medication until at least 72 hours after treatment], implants, injectables, combined oral contraceptives, hormonal intrauterine devices [IUDs]).
- Physician diagnosis of mild intermittent seasonal asthma
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- Non-smokers, or ex-smokers
- Forced expiratory volume in 1 second (FEV1) > 80% of the predicted value
- Positive skin prick test for grass mix at or within 12 months prior to the screening visit
- Able and willing to give written informed consent to take part in the study
- Available to complete all study measurements
- Able to restrain from particle rich atmosphere (e.g. passive cigarette smoke) within 1 week before exposure to UFP or clean air
Who cannot join
- Infections of the respiratory tract within the last month
- 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, endocrine disease or pulmonary disease (including but not confined to chronic bronchitis, emphysema, tuberculosis, bronchiectasis or cystic fibrosis).
- Pathological findings in safety laboratory tests
- Subjects with clinically relevant infection or known ongoing clinically relevant inflammatory process
- Suspected hypersensitivity to any ingredients of the medication involved with bronchoscopy (bronchodilators, sedatives and local anaesthetics)
- Specific immunotherapy (SIT) within two years prior to the study
Show all 12Show fewer
- Administration of oral, injectable, or dermal corticosteroids according to 9.2
- Neurological or psychiatric disease or history of drug or alcohol abuse which would interfere with the subject's proper completion of the protocol assignment
- Risk of non-compliance with study procedures
- Participation in another clinical trial 30 days prior to enrolment
- Suspected inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study.
- Unlikely to comply with the protocol requirements, instructions and study-related restrictions; e.g., language problems, uncooperative attitude, inability to return for follow-up visits, and improbability of completing the study
Trial locations and contacts
1 site in 1 country.
Germany1 site
Fraunhofer-Institut für Toxikologie und Experimentelle Medizin
Hanover, Lower Saxony, 30623
About this study
Official title: Mono-Center, Double-Blind, Cross-Over Study to Explore the Effects of Two Hour Inhalation of Ultrafine Carbon Black Particles Versus Filtered Air on Airway Inflammation Induced by Segmental Allergen Challenge in Asthmatics
The aim of the study is to test the hypothesis that the allergic airway inflammation in asthmatic patients will be enhanced after exposure to ultrafine particles (UFP). In order to test this in a controlled study, the researchers combine controlled exposure to carbon black model UFP with the well-established model of a segmental allergen challenge, which allows the researchers to safely induce circumscript allergic inflammation in the lung in mild asthmatics. The effect of the UFP on allergic inflammation will be controlled by an inhalation of clean air in a randomized, double-blind, crossover design.
- Conditions
- Asthma
- Being tested
- Bronchoscopy, Exposure to ultrafine carbon black particles
- Keywords
- Asthma GINA 1
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BronchoscopyProcedure or surgery
bronchoscopy with segmental allergen challenge
Exposure to ultrafine carbon black particlesOther
Exposure to ultrafine carbon black particles for 2 hours
What is being measured
The primary outcome is the main question the study is designed to answer.
difference of the number of total cells in bronchoalveolar lavage resulting in the comparison of allergenic versus control segments
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fraunhofer-Institute of Toxicology and Experimental Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Investigators
- Norbert Krug, Professor, MD, Principal investigator, Fraunhofer-Institut, Toxikologie und Experimentelle Medizin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00527462
- Sponsor's protocol ID
- 07/06 UFP-SFB DFG
- Status last verified
- Apr 2008
- First submitted
- 10 Sep 2007
- Last updated
- 30 Apr 2008
- Results posted
- No
Publications
Schaumann F, Fromke C, Dijkstra D, Alessandrini F, Windt H, Karg E, Muller M, Winkler C, Braun A, Koch A, Hohlfeld JM, Behrendt H, Schmid O, Koch W, Schulz H, Krug N. Effects of ultrafine particles on the allergic inflammation in the lung of asthmatics: results of a double-blinded randomized cross-over clinical pilot study. Part Fibre Toxicol. 2014 Sep 10;11:39. doi: 10.1186/s12989-014-0039-3.
PubMed 25204642
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mono-Center, Double-Blind, Cross-Over Study to Explore the Effects of Two Hour Inhalation of Ultrafine Carbon Black Particles Versus Filtered Air on Airway Inflammation Induced by Segmental Allergen Challenge in Asthmatics
- ClinicalTrials.gov ID
- NCT00527462
- Acronym / sponsor ID
- 07/06 UFP-SFB DFG
- Conditions
- Asthma
- Keywords
- Asthma GINA 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Fraunhofer-Institute of Toxicology and Experimental MedicineUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- Sep 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 11 Sep 2007 (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 aim of the study is to test the hypothesis that the allergic airway inflammation in asthmatic patients will be enhanced after exposure to ultrafine particles (UFP). In order to test this in a controlled study, the researchers combine controlled exposure to carbon black model UFP with the well-established model of a segmental allergen challenge, which allows the researchers to safely induce circumscript allergic inflammation in the lung in mild asthmatics. The effect of the UFP on allergic inflammation will be controlled by an inhalation of clean air in a randomized, double-blind, crossover design.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Male and female subjects, aged 18-45 years.
- Women will be considered for inclusion if they are:
- Physician diagnosis of mild intermittent seasonal asthma
- Non-smokers, or ex-smokers
- Forced expiratory volume in 1 second (FEV1) > 80% of the predicted value
Key exclusion criteria (12 listed)
- Infections of the respiratory tract within the last month
- 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, endocrine disease or pulmonary disease (including but not confined to chronic bronchitis, emphysema, tuberculosis, bronchiectasis or cystic fibrosis).
- Pathological findings in safety laboratory tests
- Subjects with clinically relevant infection or known ongoing clinically relevant inflammatory process
- Suspected hypersensitivity to any ingredients of the medication involved with bronchoscopy (bronchodilators, sedatives and local anaesthetics)
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 |
|---|---|---|
| Bronchoscopybronchoscopy with segmental allergen challenge | Procedure or surgery | – |
| Exposure to ultrafine carbon black particlesExposure to ultrafine carbon black particles for 2 hours | Other | – |
Primary outcome
difference of the number of total cells in bronchoalveolar lavage resulting in the comparison of allergenic versus control segments
Time frame: 24 hours
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 30 Apr 2008.
- Derived from this study: PubMed 25204642Schaumann F, Fromke C, Dijkstra D, Alessandrini F, Windt H, Karg E, Muller M, Winkler C, Braun A, Koch A, Hohlfeld JM, Behrendt H, Schmid O, Koch W, Schulz H, Krug N. Effects of ultrafine particles on the allergic inflammation in the lung of asthmatics: results of a double-blinded randomized cross-over clinical pilot study. Part Fibre Toxicol. 2014 Sep 10;11:39. doi: 10.1186/s12989-014-0039-3.
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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.
Norbert Krug, Professor, MD principal investigator
Fraunhofer-Institut, Toxikologie und Experimentelle Medizin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bronchoscopy and Exposure to ultrafine carbon black particles 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 12 inclusion and 12 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 30 Apr 2008. 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 number of total cells in bronchoalveolar lavage resulting in the comparison of allergenic versus control segments (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00527462, which also lists 1 linked publication.
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 30 Apr 2008.