Nasal AllergiesNCT01494948
Innate Immunity and the Allergic Response
A study testing allergen challenge in people with Nasal Allergies, run by Medical College of Wisconsin.
Trial summary
The purpose of this study is to determine if a certain cell type (the CD49d+ neutrophil) is associated with the presence or development of allergic disease. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasal Allergies
- What is being tested?
- allergen challenge
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to Mar 2013
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must give written informed consent before any study related activity is performed
- Male and female adult and adolescent patients aged ≥18 years and ≤ 65 years.
- Allergic or non-allergic subjects as proven by allergy skin tests in the past 2 years.
Who cannot join
- The presence of any of these diseases: Atopic dermatitis, persistent controlled asthma, any level of severity of uncontrolled asthma, immunodeficiency or suspected immunodeficiency, any co-morbid disease (cardiac, congenital, diabetes, renal, gastrointestinal, hematologic, and oncologic).
- Any prior history of immunodeficiency, cardiac, congenital, diabetes, renal, gastrointestinal, hematologic, or oncologic disease.
- The use of any intranasal and inhaled corticosteroids within the last month.
- Current therapy with any medication other than as needed over-the-counter medications or as-needed (not scheduled) antihistamine use.
- Current pregnancy.
- Women of childbearing potential not using an acceptable birth control method, as well as women who are breastfeeding
- Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (specify as required)
- Use of any other investigational agent in the last 30 days
About this study
The purpose of this study is to determine if a certain cell type (the CD49d+ neutrophil) is associated with the presence or development of allergic disease.
Read the detailed description
A specific subset of neutrophils (CD49d+) will be recruited to the nasal tissue of individuals with allergic disease, and that these cells will also be found in the peripheral blood of allergic subjects. Normal subjects (those without atopy) and those treated for atopic disease will lack the presence of these cells.
- Conditions
- Nasal Allergies
- Being tested
- allergen challenge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allergen challengeOther
nasal challenges with antigen to which they are sensitive to
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | skin test negative Receives: Other: allergen challenge |
| allergic | Active comparator | Skin test positive Receives: Other: allergen challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in percentage of CD49d expressing neutrophils in nasal lavage post allergen challenge.
Nasal lavage on atopic and non-atopic adult subjects will be performed at baseline and following an allergen challenge. The frequency of CD49d expressing neutrophils in the lavage fluid will be determined by flow cytometry analysis, and the change in this frequency will be correlated with atopic status and allergen challenge. This is an observational study, procedures performed are not intended to impact the outcome of the individual participants.
Measured: 1month
Secondary outcomes (1)
Change in immune cell numbers in the nasal lavage following allergen challenge
The numbers of neutrophils, CD49d+ neutrophils, lymphocytes, dendritic cells, and macrophages in the nasal lavage will be determined before and after allergen challenge. The outcome will be correlation of these changes with allergy status and any clinical symptoms of the allergen challenge (i.e., sneezing).
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2011 (estimated)
- Study startMar 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nasal AllergiesStudies 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
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Mitchell Grayson, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01494948
- Sponsor's protocol ID
- 221035-2
- Status last verified
- Jan 2014
- First submitted
- 7 Nov 2011
- Last updated
- 8 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Sigua JA, Buelow B, Cheung DS, Buell E, Hunter D, Klancnik M, Grayson MH. CD49d-expressing neutrophils differentiate atopic from nonatopic individuals. J Allergy Clin Immunol. 2014 Mar;133(3):901-4.e5. doi: 10.1016/j.jaci.2013.09.035. Epub 2013 Dec 18. No abstract available.
PubMed 24360325
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innate Immunity and the Allergic Response
- ClinicalTrials.gov ID
- NCT01494948
- Acronym / sponsor ID
- 221035-2
- Conditions
- Nasal Allergies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Mar 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 19 Dec 2011 (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 determine if a certain cell type (the CD49d+ neutrophil) is associated with the presence or development of allergic disease.
Detailed description
A specific subset of neutrophils (CD49d+) will be recruited to the nasal tissue of individuals with allergic disease, and that these cells will also be found in the peripheral blood of allergic subjects. Normal subjects (those without atopy) and those treated for atopic disease will lack the presence of these cells.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Other: allergen challengeskin test negative |
| allergic | Active comparator | Other: allergen challengeSkin test positive |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must give written informed consent before any study related activity is performed
- Male and female adult and adolescent patients aged ≥18 years and ≤ 65 years.
- Allergic or non-allergic subjects as proven by allergy skin tests in the past 2 years.
Key exclusion criteria (8 listed)
- The presence of any of these diseases: Atopic dermatitis, persistent controlled asthma, any level of severity of uncontrolled asthma, immunodeficiency or suspected immunodeficiency, any co-morbid disease (cardiac, congenital, diabetes, renal, gastrointestinal, hematologic, and oncologic).
- Any prior history of immunodeficiency, cardiac, congenital, diabetes, renal, gastrointestinal, hematologic, or oncologic disease.
- The use of any intranasal and inhaled corticosteroids within the last month.
- Current therapy with any medication other than as needed over-the-counter medications or as-needed (not scheduled) antihistamine use.
- Current pregnancy.
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 |
|---|---|---|
| allergen challengenasal challenges with antigen to which they are sensitive to | Other | allergic, placebo |
Primary outcome
Increase in percentage of CD49d expressing neutrophils in nasal lavage post allergen challenge.
Time frame: 1month
Nasal lavage on atopic and non-atopic adult subjects will be performed at baseline and following an allergen challenge. The frequency of CD49d expressing neutrophils in the lavage fluid will be determined by flow cytometry analysis, and the change in this frequency will be correlated with atopic status and allergen challenge. This is an observational study, procedures performed are not intended to impact the outcome of the individual participants.
1 secondary outcome
Change in immune cell numbers in the nasal lavage following allergen challenge
Time frame: 1 month
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 8 Jan 2014.
- Results publication: PubMed 24360325Sigua JA, Buelow B, Cheung DS, Buell E, Hunter D, Klancnik M, Grayson MH. CD49d-expressing neutrophils differentiate atopic from nonatopic individuals. J Allergy Clin Immunol. 2014 Mar;133(3):901-4.e5. doi: 10.1016/j.jaci.2013.09.035. Epub 2013 Dec 18. No abstract available.
Related trials for Nasal Allergies
Active, not recruiting
Laser Posterior Nasal Nerve Neurolysis
Allergic Rhinitis, Chronic Rhinitis
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.
Mitchell Grayson, MD principal investigator
Medical College of Wisconsin
Questions about this trial
What is this clinical trial studying?
A study testing allergen challenge in people with Nasal Allergies, run by Medical College of Wisconsin.
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 8 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 8 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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.
What does the primary outcome measure?
Increase in percentage of CD49d expressing neutrophils in nasal lavage post allergen challenge. (time frame: 1month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01494948, which also lists 1 linked publication.
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 8 Jan 2014; AzTrials last refreshed its copy on 30 Oct 2026.