Allergic RhinitisNCT00915447
Diesel Exhaust Particles and Leukotriene Production
An observational study of Allergic Rhinitis, run by University of California, Los Angeles at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergic Rhinitis
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to 11 Apr 2013
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Community sample
Who may be able to join
- Age 18 to 65 years old.
- Positive prick (epicutaneous) skin test to standardized cat with a wheal equal to or greater than 3 mm and with a surrounding flare.
- Ability to give informed consent.
Who cannot join
- Pregnancy or breast-feeding. (Pregnancy and the period during breast feeding can affect nasal congestion and be a confounder in this regard.)
- Systemic corticosteroid use within the previous three months or anytime during the challenge protocol.
- Topical nasal corticosteroid use within the past month or anytime during the challenge protocol.
- Systemic antihistamines or decongestant use within past two weeks or anytime during the trial.
- Chronic sinusitis or chronic non-allergic rhinitis.
- Use of reserpine.
Show all 14Show fewer
- Cigarette smoking within the past year or during the challenge protocol
- 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.
- Present or treatment within the past 10 years with allergy immunotherapy (injections).
- Present or past treatment with anti-IgE therapy.
- 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.
- Living arrangement where the subject has a cat dwelling within the subject's habitation.
- 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.
- Use of asthma-required medications.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles
Los Angeles, California, 90095-1680
About this study
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.
- Conditions
- Allergic Rhinitis
- Keywords
- Cat Allergic Rhinitis
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cat Allergic Rhinitis | Individuals with cat allergic rhinitis, yet without routine cat exposure |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2009 (estimated)
- Study startApr 2008
- Primary completion11 Apr 2013
- Study completion11 Apr 2013
Why it stopped: Investigator left the institution prior to enrollment of first participant
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Marc Riedl, M.D., M.S., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00915447
- Sponsor's protocol ID
- IRB # 07-10-025
- Other IDs
- FAU # 441329-ZC-77586
- Status last verified
- Jan 2019
- First submitted
- 5 Jun 2009
- Last updated
- 23 Jan 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diesel Exhaust Particles and Leukotriene Production
- ClinicalTrials.gov ID
- NCT00915447
- Acronym / sponsor ID
- IRB # 07-10-025
- Conditions
- Allergic Rhinitis
- Keywords
- Cat Allergic Rhinitis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Investigator left the institution prior to enrollment of first participant
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Apr 2008 (actual)
- Primary completion
- 11 Apr 2013 (actual)
- Study completion
- 11 Apr 2013 (actual)
- First posted
- 8 Jun 2009 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cat Allergic Rhinitis | – | –Individuals with cat allergic rhinitis, yet without routine cat exposure |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample
Key inclusion criteria (3 listed)
- Age 18 to 65 years old.
- Positive prick (epicutaneous) skin test to standardized cat with a wheal equal to or greater than 3 mm and with a surrounding flare.
- Ability to give informed consent.
Key exclusion criteria (14 listed)
- Pregnancy or breast-feeding. (Pregnancy and the period during breast feeding can affect nasal congestion and be a confounder in this regard.)
- Systemic corticosteroid use within the previous three months or anytime during the challenge protocol.
- Topical nasal corticosteroid use within the past month or anytime during the challenge protocol.
- Systemic antihistamines or decongestant use within past two weeks or anytime during the trial.
- Chronic sinusitis or chronic non-allergic rhinitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
Related trials for Allergic Rhinitis
Not yet recruitingPhase 1
Safety and Tolerability of Fluticasone Propionate 10% Nasal Insert in Participants With Chronic Allergic Rhinitis
Chronic Allergic Rhinitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
Not yet recruitingObservational study
Prevelance of Bronchial Asthma and Allergic Rhinitis Among Children With Nephrotic Syndrom at Sohag University Hospital
Allergic Diseases in Nephrotic Children, Nephrotic Syndrom
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.
Marc Riedl, M.D., M.S. principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Rhinitis, run by University of California, Los Angeles at 1 site in United States.
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 3 inclusion and 14 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: withdrawn, as of the sponsor's last update on 23 Jan 2019. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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.
Where can I read the original study information?
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 23 Jan 2019.