Novel Noninvasive Techniques to Study Neutrophil Airway Inflammation in an Ozone Challenge Model

This study has been completed.
Sponsor:
Information provided by:
Fraunhofer-Institute of Toxicology and Experimental Medicine
ClinicalTrials.gov Identifier:
NCT00743704
First received: August 28, 2008
Last updated: April 18, 2009
Last verified: April 2009
  Purpose

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.


Condition Intervention
Healthy Subjects
Other: ozoneexposure

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Novel Noninvasive Techniques to Study Neutrophil Airway Inflammation in an Ozone Challenge Model

Resource links provided by NLM:


Further study details as provided by Fraunhofer-Institute of Toxicology and Experimental Medicine:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: August 2008
Study Completion Date: April 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: ozoneexposure
    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.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00743704

Locations
Germany
Fraunhofer-Institut für Toxikologie und Experimentelle Medizin
Hannover, Niedersachsen, Germany, 30625
Sponsors and Collaborators
Fraunhofer-Institute of Toxicology and Experimental Medicine
Investigators
Principal Investigator: Jens Hohlfeld, MD Fraunhofer ITEM
  More Information

Additional Information:
No publications provided by Fraunhofer-Institute of Toxicology and Experimental Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jens Hohlfeld, MD, Fraunhofer-Institute of Toxicology and Experimental Medicine
ClinicalTrials.gov Identifier: NCT00743704     History of Changes
Other Study ID Numbers: 08/04 Ozelot
Study First Received: August 28, 2008
Last Updated: April 18, 2009
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014