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Diesel Exhaust Particles and Leukotriene Production

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by University of California, Los Angeles.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00915447
First received: June 5, 2009
Last updated: August 19, 2010
Last verified: August 2010
  Purpose

The purpose of this study is to measure the effects of allergens and/or diesel exhaust particles in the nose to learn more about allergic responses in individuals with cat allergic rhinitis.


Condition
Allergic Rhinitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diesel Exhaust Particles and Leukotriene Production

Further study details as provided by University of California, Los Angeles:

Biospecimen Retention:   Samples Without DNA

Urine, Nasal Lavage


Estimated Enrollment: 25
Study Start Date: January 2008
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cat Allergic Rhinitis
Individuals with cat allergic rhinitis, yet without routine cat exposure

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Community sample

Criteria

Inclusion Criteria:

  1. Age 18 to 65 years old.
  2. Positive prick (epicutaneous) skin test to standardized cat with a wheal equal to or greater than 3 mm and with a surrounding flare.
  3. Ability to give informed consent.

Exclusion Criteria:

  1. Pregnancy or breast-feeding. (Pregnancy and the period during breast feeding can affect nasal congestion and be a confounder in this regard.)
  2. Systemic corticosteroid use within the previous three months or anytime during the challenge protocol.
  3. Topical nasal corticosteroid use within the past month or anytime during the challenge protocol.
  4. Systemic antihistamines or decongestant use within past two weeks or anytime during the trial.
  5. Chronic sinusitis or chronic non-allergic rhinitis.
  6. Use of reserpine.
  7. Cigarette smoking within the past year or during the challenge protocol
  8. Use of topical nasal antihistamines, chromoglycolates (chromolyn, Cromlon®), decongestants or non-steroidal anti-inflammatory agents (NSIADS) within the preceding week or anytime during the challenge protocol.
  9. Present or treatment within the past 10 years with allergy immunotherapy (injections).
  10. Present or past treatment with anti-IgE therapy.
  11. Any unusual exposure to air pollutants (e.g., working as a diesel mechanic) that, in the opinion of the investigators, might compromise the individual's ability to participate in the study.
  12. Living arrangement where the subject has a cat dwelling within the subject's habitation.
  13. Any serious heart, lung, neurological or kidney disease that in the opinion of the investigators would impair the individual's ability to participate in the study.
  14. Use of asthma-required medications.
  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: NCT00915447

Locations
United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90095-1680
Sponsors and Collaborators
University of California, Los Angeles
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Marc Riedl, M.D., M.S. University of California, Los Angeles
  More Information

No publications provided

Responsible Party: Marc Riedl, M.D., M.S., University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00915447     History of Changes
Other Study ID Numbers: IRB # 07-10-025, FAU # 441329-ZC-77586
Study First Received: June 5, 2009
Last Updated: August 19, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
Cat Allergic Rhinitis

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on November 20, 2014