Allergic RhinitisNCT01461200
Effects of Allergic Rhinitis on the Nasal/Sinus Microbiome
An observational study of Allergic Rhinitis, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of this study is to find out if the bacteria present in the nose or sinuses of people with seasonal allergies changes during their allergy season. Another purpose of this study is to see if the bacteria present in the nose and sinuses of non-allergic people are the same as allergic people before the… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Swab of vestibule and middle meatus of nose
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Feb 2012
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients with seasonal allergies and healthy controls from the community.
Who may be able to join
- Males and females between 18 and 55 years of age.
- History of tree and/or grass allergic rhinitis for at least 2 years (allergic subjects) or no allergy history at all (normal controls).
- For allergic subjects, a positive skin test to trees and/or grass antigen within prior 12 months. For non-allergic subjects, negative skin tests to common allergens in the Chicago area.
Who cannot join
- Respiratory disease other than allergic rhinitis, allergic conjunctivitis and mild asthma.
- Use of nasal steroids, antihistamines in the last 4 weeks.
- Upper respiratory infection, sinusitis less than 2 weeks before screening.
- Structural nasal abnormalities or nasal polyps on examination, nasal ulcer, frequent nose bleeding, recent nasal surgery or nasal trauma (within 90 days).
- Participation in other investigational therapy in the last 30 days.
- Any systemic disorder or medication interfering with the study.
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- Undergoing allergen desensitization therapy.
- Not willing to give informed consent
- Inability to understand the nature and requirements of the study, or to comply with the study procedures.
- Any social or medical condition that, in the opinion of the investigator, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Parallel Group Observational Study of the Effects of Allergic Rhinitis on the Nasal/Sinus Microbiome
The purpose of this study is to find out if the bacteria present in the nose or sinuses of people with seasonal allergies changes during their allergy season. Another purpose of this study is to see if the bacteria present in the nose and sinuses of non-allergic people are the same as allergic people before the allergy season and if it changes during the season. Many bacteria are difficult to grow in the laboratory so the investigators are using analysis of DNA (the genetic material in cells) of the bacteria in the nose and sinus to find them. The investigators will be testing DNA of the bacteria only and not of the human subjects taking part in this study. This research is being done to help us understand how allergy affects bacteria in the nose and sinuses.
- Conditions
- Allergic Rhinitis
- Being tested
- Swab of vestibule and middle meatus of nose
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swab of vestibule and middle meatus of noseOther
Swabs of vestibule and middle meatus of nose will be taken prior to and during the grass/tree allergy season
| Study group | Role | What they receive |
|---|---|---|
| Non allergics | Not described Receives: Other: Swab of vestibule and middle meatus of nose | |
| allergics | Not described Receives: Other: Swab of vestibule and middle meatus of nose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bacterial profile of the sinuses
DNA isolation to determine the bacterial profiles of samples taken at baseline (out of subjects' allergy season) and 1 to 3 months later during subjects' allergy season.
Measured: Measured at baseline and 1 to 3 months later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2011 (estimated)
- Study startMar 2011
- Primary completionJan 2012
- Study completionFeb 2012
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 ChicagoThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Robert Naclerio, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01461200
- Sponsor's protocol ID
- 10-712-A
- Status last verified
- Mar 2014
- First submitted
- 24 Oct 2011
- Last updated
- 27 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Parallel Group Observational Study of the Effects of Allergic Rhinitis on the Nasal/Sinus Microbiome
- ClinicalTrials.gov ID
- NCT01461200
- Acronym / sponsor ID
- 10-712-A
- Conditions
- Allergic Rhinitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Mar 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 28 Oct 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 find out if the bacteria present in the nose or sinuses of people with seasonal allergies changes during their allergy season. Another purpose of this study is to see if the bacteria present in the nose and sinuses of non-allergic people are the same as allergic people before the allergy season and if it changes during the season. Many bacteria are difficult to grow in the laboratory so the investigators are using analysis of DNA (the genetic material in cells) of the bacteria in the nose and sinus to find them. The investigators will be testing DNA of the bacteria only and not of the human subjects taking part in this study. This research is being done to help us understand how allergy affects bacteria in the nose and sinuses.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non allergics | – | Other: Swab of vestibule and middle meatus of nose |
| allergics | – | Other: Swab of vestibule and middle meatus of nose |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with seasonal allergies and healthy controls from the community.
Key inclusion criteria (3 listed)
- Males and females between 18 and 55 years of age.
- History of tree and/or grass allergic rhinitis for at least 2 years (allergic subjects) or no allergy history at all (normal controls).
- For allergic subjects, a positive skin test to trees and/or grass antigen within prior 12 months. For non-allergic subjects, negative skin tests to common allergens in the Chicago area.
Key exclusion criteria (10 listed)
- Respiratory disease other than allergic rhinitis, allergic conjunctivitis and mild asthma.
- Use of nasal steroids, antihistamines in the last 4 weeks.
- Upper respiratory infection, sinusitis less than 2 weeks before screening.
- Structural nasal abnormalities or nasal polyps on examination, nasal ulcer, frequent nose bleeding, recent nasal surgery or nasal trauma (within 90 days).
- Participation in other investigational therapy in the last 30 days.
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 |
|---|---|---|
| Swab of vestibule and middle meatus of noseSwabs of vestibule and middle meatus of nose will be taken prior to and during the grass/tree allergy season | Other | Non allergics, allergics |
Primary outcome
Change in bacterial profile of the sinuses
Time frame: Measured at baseline and 1 to 3 months later.
DNA isolation to determine the bacterial profiles of samples taken at baseline (out of subjects' allergy season) and 1 to 3 months later during subjects' allergy season.
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 27 Mar 2014.
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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.
Robert Naclerio, MD principal investigator
University of Chicago
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 Chicago 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 10 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 27 Mar 2014. 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.
What does the primary outcome measure?
Change in bacterial profile of the sinuses (time frame: Measured at baseline and 1 to 3 months later.). It is what the study was designed to measure, not a finding.
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 27 Mar 2014.