Healthy SubjectsNCT00743704
Novel Noninvasive Techniques to Study Neutrophil Airway Inflammation in an Ozone Challenge Model
A study testing ozoneexposure in people with Healthy Subjects, run by Fraunhofer-Institute of Toxicology and Experimental Medicine at 1 site in Germany.
Trial summary
The primary objective of this pilot study is to establish a model of neutrophil airway inflammation for future testing of anti-inflammatory substances in an early stage of clinical development. Moreover, the suitability of an electronic nose for early detection and diagnosis of airway inflammation will be determined. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- ozoneexposure
- How many people
- 15 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2008to Apr 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able and willing to give written informed consent
- Healthy male and female nonsmokers, aged 18 to 55 years, 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 %
- 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)
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- 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)
- Subjects must be able to produce adequate sputum
- Subjects must be responsive to ozone in a screening challenge (250 ppb, 3h) defined by a ≥ 10 % increase in sputum neutrophils 6 h after the start of ozone exposure
Who cannot join
- Upper or lower respiratory tract infection in the last four weeks prior to screening
- Subjects with a positive skin prick test to common aeroallergens will be excluded
- Past or present disease, which as judged by the investigator, may affect the outcome of the 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 asthma, tuberculosis, bronchiectasis or cystic fibrosis)
- Regular intake of any prescribed or over the counter medication. Exceptions include paracetamol for pain relief, oral contraceptive medication, hormonal replacement therapy, dietary and vitamin supplements
- Participation in another clinical trial 30 days prior to enrolment
- Administration of corticosteroids within the last 4 weeks prior to screening
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Fraunhofer-Institut für Toxikologie und Experimentelle Medizin
Hanover, Lower Saxony, 30625
About this study
The primary objective of this pilot study is to establish a model of neutrophil airway inflammation for future testing of anti-inflammatory substances in an early stage of clinical development. Moreover, the suitability of an electronic nose for early detection and diagnosis of airway inflammation will be determined.
Read the detailed description
Experimental ozone exposure of human subjects is known to induce transient neutrophilic airway inflammation with sputum neutrophilia and elevated concentrations of inflammatory mediators in bronchoalveolar lavage and sputum supernatants. In this study, ozone at a concentration of 250 ppb will be inhaled for three hours in an ozone challenge chamber.
In a recent study, ozone challenge has been discussed as a model for pulmonary diseases dominated by neutrophilic inflammation such as COPD, providing the possibility to test new anti-inflammatory substances in early stages of clinical development.
- Conditions
- Healthy Subjects
- Being tested
- ozoneexposure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ozoneexposureOther
subjects will be exposed to either ozone (250 ppb) or filtered air in an ozone challenge chamber for three hours. Ventilation will be increased to 20 l/min/m2 by intermittent exercise on a bicycle ergometer.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of smellprints in exhaled breath
Measured: at the end of ozone exposure and 6 h and 24 h after the start of challenge compared with baseline and exposure to filtered air
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionMar 2009
- Study completionApr 2009
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 Healthy SubjectsStudies 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, Investigator, Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fraunhofer-Institute of Toxicology and Experimental Medicine
- Sponsor type
- University, hospital or other
- Investigators
- Jens Hohlfeld, MD, Principal investigator, Fraunhofer ITEM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00743704
- Sponsor's protocol ID
- 08/04 Ozelot
- Status last verified
- Apr 2009
- First submitted
- 28 Aug 2008
- Last updated
- 21 Apr 2009
- Results posted
- No
Publications
Biller H, Holz O, Windt H, Koch W, Muller M, Jorres RA, Krug N, Hohlfeld JM. Breath profiles by electronic nose correlate with systemic markers but not ozone response. Respir Med. 2011 Sep;105(9):1352-63. doi: 10.1016/j.rmed.2011.03.002. Epub 2011 Mar 24.
PubMed 21439804
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Noninvasive Techniques to Study Neutrophil Airway Inflammation in an Ozone Challenge Model
- ClinicalTrials.gov ID
- NCT00743704
- Acronym / sponsor ID
- 08/04 Ozelot
- Conditions
- Healthy Subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Fraunhofer-Institute of Toxicology and Experimental MedicineUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 29 Aug 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 pilot study is to establish a model of neutrophil airway inflammation for future testing of anti-inflammatory substances in an early stage of clinical development. Moreover, the suitability of an electronic nose for early detection and diagnosis of airway inflammation will be determined.
Detailed description
Experimental ozone exposure of human subjects is known to induce transient neutrophilic airway inflammation with sputum neutrophilia and elevated concentrations of inflammatory mediators in bronchoalveolar lavage and sputum supernatants. In this study, ozone at a concentration of 250 ppb will be inhaled for three hours in an ozone challenge chamber.
In a recent study, ozone challenge has been discussed as a model for pulmonary diseases dominated by neutrophilic inflammation such as COPD, providing the possibility to test new anti-inflammatory substances in early stages of clinical development.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Able and willing to give written informed consent
- Healthy male and female nonsmokers, aged 18 to 55 years, 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 %
- Available to complete all study measurements
- Women will be considered for inclusion if they are:
- Subjects must be able to produce adequate sputum
Key exclusion criteria (8 listed)
- Upper or lower respiratory tract infection in the last four weeks prior to screening
- Subjects with a positive skin prick test to common aeroallergens will be excluded
- Past or present disease, which as judged by the investigator, may affect the outcome of the 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 asthma, tuberculosis, bronchiectasis or cystic fibrosis)
- Regular intake of any prescribed or over the counter medication. Exceptions include paracetamol for pain relief, oral contraceptive medication, hormonal replacement therapy, dietary and vitamin supplements
- Participation in another clinical trial 30 days prior to enrolment
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 |
|---|---|---|
| ozoneexposuresubjects will be exposed to either ozone (250 ppb) or filtered air in an ozone challenge chamber for three hours. Ventilation will be increased to 20 l/min/m2 by intermittent exercise on a bicycle ergometer. | Other | – |
Primary outcome
Change of smellprints in exhaled breath
Time frame: at the end of ozone exposure and 6 h and 24 h after the start of challenge compared with baseline and exposure to filtered air
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 21 Apr 2009.
- Derived from this study: PubMed 21439804Biller H, Holz O, Windt H, Koch W, Muller M, Jorres RA, Krug N, Hohlfeld JM. Breath profiles by electronic nose correlate with systemic markers but not ozone response. Respir Med. 2011 Sep;105(9):1352-63. doi: 10.1016/j.rmed.2011.03.002. Epub 2011 Mar 24.
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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.
Jens Hohlfeld, 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 ozoneexposure in people with Healthy Subjects, 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 9 inclusion and 8 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 21 Apr 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?
Change of smellprints in exhaled breath (time frame: at the end of ozone exposure and 6 h and 24 h after the start of challenge compared with baseline and exposure to filtered air). 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 NCT00743704, 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 21 Apr 2009.