Allergic RhinitisNCT00011440
Pollutant Altered Allergic Responses
An observational study of Allergic Rhinitis and Allergy, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
Trial summary
This study is designed to investigate whether exposure to particulate air pollution increases the allergic response to allergens. Research studies suggest that symptoms in individuals with allergies may be aggravated by exposure to particulate air pollution. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Rhinitis, Allergy
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 1998to Aug 2002
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Adult without a history of asthma or respiratory disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
Harvard School of Public Health
Boston, Massachusetts, 02115
About this study
Official title: Markers of Pollutant Altered Allergic Responses
This study is designed to investigate whether exposure to particulate air pollution increases the allergic response to allergens. Research studies suggest that symptoms in individuals with allergies may be aggravated by exposure to particulate air pollution. We sought to experimental determine this by exposing human volunteers to combustion particles, a component of air pollution, and then challenge them with an allergen such as ragweed or oak tree pollen. Using biological tests we can measure whether the allergen response is magnified by prior particulate exposure.
Read the detailed description
To study whether particulates enhance the allergic response, we chose the upper airway as a model of allergic inflammation and nasal lavage as a non-invasive method for obtaining samples. The nasal cavity is both an excellent model of allergic inflammation and provides an easily accessible site for study. We measured inflammatory cells and cytokines in the nasal lavage fluid. Our specific hypothesis was that particulate exposure prior to allergen challenge would enhance inflammatory cell recruitment and expression of inflammatory cytokines.
- Conditions
- Allergic Rhinitis, Allergy
- Keywords
- Allergy, Air pollution, Lung function, Inflammation
- Medical subject headings
- Rhinitis, Allergic, Hypersensitivity, Inflammation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2001 (estimated)
- Study startDec 1998
- Study completionAug 2002
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.
- 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
- Natural history
- Time perspective
- Prospective
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00011440
- Sponsor's protocol ID
- 8077-CP-001
- Status last verified
- Mar 2006
- First submitted
- 20 Feb 2001
- Last updated
- 23 Mar 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Markers of Pollutant Altered Allergic Responses
- ClinicalTrials.gov ID
- NCT00011440
- Acronym / sponsor ID
- 8077-CP-001
- Conditions
- Allergic Rhinitis, Allergy
- Keywords
- Allergy, Air pollution, Lung function, Inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- Dec 1998
- Study completion
- Aug 2002
- First posted
- 21 Feb 2001 (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.
This study is designed to investigate whether exposure to particulate air pollution increases the allergic response to allergens. Research studies suggest that symptoms in individuals with allergies may be aggravated by exposure to particulate air pollution. We sought to experimental determine this by exposing human volunteers to combustion particles, a component of air pollution, and then challenge them with an allergen such as ragweed or oak tree pollen. Using biological tests we can measure whether the allergen response is magnified by prior particulate exposure.
Detailed description
To study whether particulates enhance the allergic response, we chose the upper airway as a model of allergic inflammation and nasal lavage as a non-invasive method for obtaining samples. The nasal cavity is both an excellent model of allergic inflammation and provides an easily accessible site for study. We measured inflammatory cells and cytokines in the nasal lavage fluid. Our specific hypothesis was that particulate exposure prior to allergen challenge would enhance inflammatory cell recruitment and expression of inflammatory cytokines.
Study design
- Observational model
- Natural history
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2006.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Allergy, run by National Institute of Environmental Health Sciences (NIEHS) 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?
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: finished, as of the sponsor's last update on 23 Mar 2006. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Mar 2006.