Seasonal Allergic RhinitisPhase 4NCT00361439
Treatment of Olfactory Dysfunction in Seasonal Allergic Rhinitis
A Phase 4 study testing Mometasone in people with Seasonal Allergic Rhinitis, run by University of Chicago at 1 site in United States.
Trial summary
People with allergies frequently complain of a loss or reduction in the sense of smell. In this study, the investigators propose to perform a randomized, double blind, placebo controlled parallel study of subjects with nasal allergies and decreased smell to determine the effect of a treatment for allergies on the… Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- Mometasone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Sep 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females between 18 and 59 years of age.
- Seasonal allergic rhinitis by clinical history, with symptoms of impaired olfaction.
- Positive skin or RAST test to allergen.
- Symptoms of olfactory dysfunction.
- No significant history of chronic sinusitis.
Who cannot join
- Women of childbearing potential not using the contraception method(s) (Birth control pills, depo Provera, double barrier) 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 (heart, lung, kidney, neurological, oncologic or liver disease).
- Use of any other investigational agent in the last 30 days.
- Absence of olfactory or nasal symptoms.
- Use of medications that may affect olfaction.
- Medical conditions that may affect olfaction.
- Smoking.
- URI at the time of screening.
Trial locations and contacts
1 site in 1 country.
About this study
People with allergies frequently complain of a loss or reduction in the sense of smell.
In this study, the investigators propose to perform a randomized, double blind, placebo controlled parallel study of subjects with nasal allergies and decreased smell to determine the effect of a treatment for allergies on the sense of smell.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- Mometasone, Placebo
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MometasoneDrug
Also called Nasonex
2 puffs in each nostril once daily of nasal spray
PlaceboDrug
2 puffs in each nostril once daily of nasal spray
| Study group | Role | What they receive |
|---|---|---|
| Mometasone | Active comparator | Mometasone intranasal steroid therapy daily for 2 weeks Receives: Drug: Mometasone |
| Placebo | Placebo comparator | 2 puffs of placebo spray in each nostril once daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological Findings
Number of eosinophils per high-powered field (HPF) in olfactory biopsy taken after 2 weeks of study treatment (higher values indicate greater inflammation); average of three HPF reported
Measured: 2 weeks
Secondary outcomes (3)
Change From Baseline in Total Nasal Symptom Score at 2 Weeks
A decrease in scores between visits signifies an improvement in nasal symptoms. The total nasal symptom score can range from 0 to 27.
Measured: baseline and 2 weeks
Change From Baseline in Nasal Peak Inspiratory Flow at 2 Weeks
An increase between visits indicates improved nasal airflow.
Measured: baseline and 2 weeks
Change From Baseline in Percentage of Eosinophils at 2 Weeks
A decrease between visits signifies a reduction in inflammation.
Calculated from cytology specimens obtained by lavage.
Measured: baseline and 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2006 (estimated)
- Study startAug 2006
- Primary completionSep 2008
- Study completionSep 2008
Why it stopped: Study stopped early due to slow accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Seasonal 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Schering-Plough
- Responsible party
- Sponsor
- Investigators
- Jayant M Pinto, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00361439
- Sponsor's protocol ID
- 14757A (P04908)
- Other IDs
- IRB #14757A
- Status last verified
- Jan 2014
- First submitted
- 4 Aug 2006
- Last updated
- 28 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Sivam A, Jeswani S, Reder L, Wang J, DeTineo M, Taxy J, Baroody FM, Naclerio RM, Pinto JM. Olfactory cleft inflammation is present in seasonal allergic rhinitis and is reduced with intranasal steroids. Am J Rhinol Allergy. 2010 Jul-Aug;24(4):286-90. doi: 10.2500/ajra.2010.24.3478.
PubMed 20819468
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Olfactory Dysfunction in Seasonal Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT00361439
- Acronym / sponsor ID
- 14757A (P04908)
- Conditions
- Seasonal Allergic Rhinitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study stopped early due to slow accrual.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Schering-Plough
- Study start
- Aug 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 8 Aug 2006 (estimated)
- Results
- Posted 23 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
People with allergies frequently complain of a loss or reduction in the sense of smell.
In this study, the investigators propose to perform a randomized, double blind, placebo controlled parallel study of subjects with nasal allergies and decreased smell to determine the effect of a treatment for allergies on the sense of smell.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mometasone | Active comparator | Drug: MometasoneMometasone intranasal steroid therapy daily for 2 weeks |
| Placebo | Placebo comparator | Drug: Placebo2 puffs of placebo spray in each nostril once daily |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Males and females between 18 and 59 years of age.
- Seasonal allergic rhinitis by clinical history, with symptoms of impaired olfaction.
- Positive skin or RAST test to allergen.
- Symptoms of olfactory dysfunction.
- No significant history of chronic sinusitis.
Key exclusion criteria (8 listed)
- Women of childbearing potential not using the contraception method(s) (Birth control pills, depo Provera, double barrier) 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 (heart, lung, kidney, neurological, oncologic or liver disease).
- Use of any other investigational agent in the last 30 days.
- Absence of olfactory or nasal symptoms.
- Use of medications that may affect olfaction.
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 |
|---|---|---|
| MometasoneAlso: Nasonex2 puffs in each nostril once daily of nasal spray | Drug | Mometasone |
| Placebo2 puffs in each nostril once daily of nasal spray | Drug | Placebo |
Primary outcome
Histological Findings
Time frame: 2 weeks
Number of eosinophils per high-powered field (HPF) in olfactory biopsy taken after 2 weeks of study treatment (higher values indicate greater inflammation); average of three HPF reported
3 secondary outcomes
Change From Baseline in Total Nasal Symptom Score at 2 Weeks
Time frame: baseline and 2 weeks
Change From Baseline in Nasal Peak Inspiratory Flow at 2 Weeks
Time frame: baseline and 2 weeks
Change From Baseline in Percentage of Eosinophils at 2 Weeks
Time frame: baseline and 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20819468Sivam A, Jeswani S, Reder L, Wang J, DeTineo M, Taxy J, Baroody FM, Naclerio RM, Pinto JM. Olfactory cleft inflammation is present in seasonal allergic rhinitis and is reduced with intranasal steroids. Am J Rhinol Allergy. 2010 Jul-Aug;24(4):286-90. doi: 10.2500/ajra.2010.24.3478.
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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.
Jayant M Pinto, 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?
A Phase 4 study testing Mometasone in people with Seasonal 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 5 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: stopped early, as of the sponsor's last update on 28 Feb 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. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Histological Findings (time frame: 2 weeks). 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 NCT00361439, 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 28 Feb 2014.