Diesel Exhaust Particles and Leukotriene Production

NCT ID: NCT00915447

Last Updated: 2019-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2008-04-30

Study Completion Date

2013-04-11

Brief Summary

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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.

Detailed Description

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Conditions

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Allergic Rhinitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cat Allergic Rhinitis

Individuals with cat allergic rhinitis, yet without routine cat exposure

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marc Riedl, M.D., M.S.

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

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University of California, Los Angeles

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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FAU # 441329-ZC-77586

Identifier Type: -

Identifier Source: secondary_id

IRB # 07-10-025

Identifier Type: -

Identifier Source: org_study_id

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