Chronic RhinosinusitisNCT01002313
Effect of Prednisone onTregs and TH17
An observational study of Chronic Rhinosinusitis, run by University of Chicago at 1 site in United States.
Trial summary
The primary objective of this study is to see whether systemic corticosteroids (such as Prednisone) have an effect on the peripheral blood Treg and Th17 function in patients with CRS. Patients are taking prednisone as part of their routine medical care. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Rhinosinusitis
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Dec 2010
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients with seasonal allergies taking prednisone and normal controls form the community.
Who may be able to join
- Diagnosis of CRS.
- A CT scan performed in the last year depicting the severity of the disease or nasal polyps on endoscopy.
- Symptomatic at the time of entry into the study as determined by scores ≥ 1.4 on the Rhinosinusitis disability index
Who cannot join
- Women who are pregnant or breastfeeding.
- Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (heart, lung, kidney, diabetes, osteoporosis, cataracts, glaucoma, neurological, oncologic, liver disease or a contraindication to taking prednisone).
- Use of any other investigational agent in the last 30 days.
- Use of clinical drugs like antihistamines, leukotriene modifiers, intranasal steroids, systemic corticosteroids in the last 15 days or immunotherapy in the last year.
- Upper respiratory infection within 14 days of study start
- Smoking within the last 2 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Prednisone on Peripheral Blood T-cell Function (Tregs and Th17) in Patients With Chronic Rhinosinusitis (CRS)
The primary objective of this study is to see whether systemic corticosteroids (such as Prednisone) have an effect on the peripheral blood Treg and Th17 function in patients with CRS. Patients are taking prednisone as part of their routine medical care.
- Conditions
- Chronic Rhinosinusitis
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 |
|---|---|---|
| normal control | Not described | |
| Patient treatment group | Treatment with prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treg cell numbers
Measured: pre treatment vs post treatment
Secondary outcomes (1)
Cytokine levels in cultured PBMCs
Measured: pre vs post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2009 (estimated)
- Study startNov 2009
- Primary completionMay 2010
- Study completionDec 2010
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 Chronic RhinosinusitisStudies 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
- Responsible party
- Sponsor
- Investigators
- Robert M Naclerio, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01002313
- Sponsor's protocol ID
- 09-254-A
- Status last verified
- Mar 2014
- First submitted
- 26 Oct 2009
- Last updated
- 27 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Watanabe S, Pinto JM, Bashir ME, De Tineo M, Suzaki H, Baroody FM, Naclerio RM, Sharma S. Effect of prednisone on nasal symptoms and peripheral blood T-cell function in chronic rhinosinusitis. Int Forum Allergy Rhinol. 2014 Aug;4(8):609-16. doi: 10.1002/alr.21336. Epub 2014 Apr 21.
PubMed 24753507
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
- Effect of Prednisone on Peripheral Blood T-cell Function (Tregs and Th17) in Patients With Chronic Rhinosinusitis (CRS)
- ClinicalTrials.gov ID
- NCT01002313
- Acronym / sponsor ID
- 09-254-A
- Conditions
- Chronic Rhinosinusitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- May 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 27 Oct 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 primary objective of this study is to see whether systemic corticosteroids (such as Prednisone) have an effect on the peripheral blood Treg and Th17 function in patients with CRS. Patients are taking prednisone as part of their routine medical care.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal control | – | – |
| Patient treatment group | – | –Treatment with prednisone |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with seasonal allergies taking prednisone and normal controls form the community.
Key inclusion criteria (3 listed)
- Diagnosis of CRS.
- A CT scan performed in the last year depicting the severity of the disease or nasal polyps on endoscopy.
- Symptomatic at the time of entry into the study as determined by scores ≥ 1.4 on the Rhinosinusitis disability index
Key exclusion criteria (6 listed)
- Women who are pregnant or breastfeeding.
- Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (heart, lung, kidney, diabetes, osteoporosis, cataracts, glaucoma, neurological, oncologic, liver disease or a contraindication to taking prednisone).
- Use of any other investigational agent in the last 30 days.
- Use of clinical drugs like antihistamines, leukotriene modifiers, intranasal steroids, systemic corticosteroids in the last 15 days or immunotherapy in the last year.
- Upper respiratory infection within 14 days of study start
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
Treg cell numbers
Time frame: pre treatment vs post treatment
1 secondary outcome
Cytokine levels in cultured PBMCs
Time frame: pre vs post treatment
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.
- Derived from this study: PubMed 24753507Watanabe S, Pinto JM, Bashir ME, De Tineo M, Suzaki H, Baroody FM, Naclerio RM, Sharma S. Effect of prednisone on nasal symptoms and peripheral blood T-cell function in chronic rhinosinusitis. Int Forum Allergy Rhinol. 2014 Aug;4(8):609-16. doi: 10.1002/alr.21336. Epub 2014 Apr 21.
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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 M 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 Chronic Rhinosinusitis, 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 6 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?
Treg cell numbers (time frame: pre treatment vs post treatment). 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 NCT01002313, 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 27 Mar 2014.