Rhinitis, Allergic, NonseasonalNCT00041821
Nasal Irritation Study: Individual Factors in Nasal Irritant Sensitivity
A study testing Nasal irritation thresholds and irritant provocation in people with Rhinitis, Allergic, Nonseasonal, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
Trial summary
This study seeks to document differences in nasal irritant sensitivity within the population. The investigators are interested in knowing whether age, gender, and allergy status (nasal allergies) predict nasal irritant sensitivity. Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Rhinitis, Allergic, Nonseasonal
- What is being tested?
- Nasal irritation thresholds and irritant provocation
- Type of treatment
- Surgery or procedure
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2000to not given
- Phase
- Interventional
- 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 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non-smokers
- 18-69 years of age
- With or without allergic rhinitis (hay fever)
- In good general health and with no prior history of asthma
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Upper Airway Biology Laboratory
Richmond, California, 94804
About this study
Official title: Individual Factors in Nasal Irritant Sensitivity
This study seeks to document differences in nasal irritant sensitivity within the population. The investigators are interested in knowing whether age, gender, and allergy status (nasal allergies) predict nasal irritant sensitivity. This is important in understanding symptom reporting patterns in air pollution situations (particularly in so-called "problem buildings"), as well as in understanding the reflex mechanism of a response of the nose to irritants (e.g., nasal congestion).
- Conditions
- Rhinitis, Allergic, Nonseasonal
- Being tested
- Nasal irritation thresholds and irritant provocation
- Keywords
- rhinitis, irritation, trigeminal
- Medical subject headings
- Rhinitis, Allergic, Perennial, Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal irritation thresholds and irritant provocationProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2002 (estimated)
- Study startSep 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rhinitis, Allergic, NonseasonalStudies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Enrolment
- 64 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
- NCT00041821
- Sponsor's protocol ID
- 10424-CP-001
- Status last verified
- Mar 2006
- First submitted
- 18 Jul 2002
- Last updated
- 23 Mar 2006
- Results posted
- No
Publications
Shusterman DJ, Murphy MA, Balmes JR. Subjects with seasonal allergic rhinitis and nonrhinitic subjects react differentially to nasal provocation with chlorine gas. J Allergy Clin Immunol. 1998 Jun;101(6 Pt 1):732-40. doi: 10.1016/S0091-6749(98)70302-1.
PubMed 9648699Shusterman D, Murphy MA, Balmes J. The influence of sex, allergic rhinitis, and test system on nasal sensitivity to airborne irritants: a pilot study. Environ Health Perspect. 2001 Jan;109(1):15-9. doi: 10.1289/ehp.0110915.
PubMed 11171519
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
- Individual Factors in Nasal Irritant Sensitivity
- ClinicalTrials.gov ID
- NCT00041821
- Acronym / sponsor ID
- 10424-CP-001
- Conditions
- Rhinitis, Allergic, Nonseasonal
- Keywords
- rhinitis, irritation, trigeminal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- Sep 2000
- First posted
- 22 Jul 2002 (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 seeks to document differences in nasal irritant sensitivity within the population. The investigators are interested in knowing whether age, gender, and allergy status (nasal allergies) predict nasal irritant sensitivity. This is important in understanding symptom reporting patterns in air pollution situations (particularly in so-called "problem buildings"), as well as in understanding the reflex mechanism of a response of the nose to irritants (e.g., nasal congestion).
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Non-smokers
- 18-69 years of age
- With or without allergic rhinitis (hay fever)
- In good general health and with no prior history of asthma
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal irritation thresholds and irritant provocation | Procedure or surgery | – |
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.
- Background: PubMed 9648699Shusterman DJ, Murphy MA, Balmes JR. Subjects with seasonal allergic rhinitis and nonrhinitic subjects react differentially to nasal provocation with chlorine gas. J Allergy Clin Immunol. 1998 Jun;101(6 Pt 1):732-40. doi: 10.1016/S0091-6749(98)70302-1.
- Background: PubMed 11171519Shusterman D, Murphy MA, Balmes J. The influence of sex, allergic rhinitis, and test system on nasal sensitivity to airborne irritants: a pilot study. Environ Health Perspect. 2001 Jan;109(1):15-9. doi: 10.1289/ehp.0110915.
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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?
A study testing Nasal irritation thresholds and irritant provocation in people with Rhinitis, Allergic, Nonseasonal, 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?
The sponsor lists 4 inclusion and 0 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: 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?
On the ClinicalTrials.gov record for NCT00041821, which also lists 2 linked publications.
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.