- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00743704
Novel Noninvasive Techniques to Study Neutrophil Airway Inflammation in an Ozone Challenge Model
Study Overview
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Niedersachsen
-
Hannover, Niedersachsen, Germany, 30625
- Fraunhofer-Institut für Toxikologie und Experimentelle Medizin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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)
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08/04 Ozelot
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy Subjects
-
BiogenCompletedHealthy Adult Subjects | Healthy Elderly SubjectsUnited States
-
PfizerCompletedHealthy Adult Subjects and Healthy Elderly SubjectsBelgium
-
Lund UniversityCompletedHealthy Subjects | Diet, HealthySweden
-
PfizerRecruitingHealthy Subjects | Healthy ParticipantsUnited States
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedHealthy | Healthy Subjects | ImmunosuppressionUnited States
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
NeuShen TherapeuticsNot yet recruiting
-
GEN İlaç ve Sağlık Ürünleri A.Ş.Sulfateq B.V.Recruiting
-
Bio-innova Co., LtdNot yet recruiting
-
Bio-innova Co., LtdNot yet recruiting