Seasonal Allergic RhinitisNCT00618332
Can a Nasal Decongestant Test Predict Treatment Outcomes in Seasonal Allergic Rhinitis?
A study testing mometasone furoate nasal spray in people with Seasonal Allergic Rhinitis, run by University of Chicago at 1 site in United States.
Trial summary
We hypothesize that those patients with purely seasonal allergic rhinitis will decongest better than those subjects with another cause contributing to their symptoms. These latter patients will not improve as well on an intranasal steroid as those who decongest well, potentially explaining the 60% response rate in… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- mometasone furoate nasal spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Jul 2010
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males and females between 18 and 60 years of age.
- History of grass and/or ragweed allergic rhinitis.
- Positive skin or RAST test to grass, trees and/or ragweed antigen.
- Symptomatic at time of entry into study.
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 pregnant or 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 nasal symptoms.
- Smoking.
- URI at the time of screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does the Response to a Nasal Decongestant Test Predict the Outcome to Treatment of Seasonal Allergic Rhinitis With Nasonex?
We hypothesize that those patients with purely seasonal allergic rhinitis will decongest better than those subjects with another cause contributing to their symptoms. These latter patients will not improve as well on an intranasal steroid as those who decongest well, potentially explaining the 60% response rate in prior studies.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- mometasone furoate nasal spray, 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.
mometasone furoate nasal sprayDrug
Also called Nasonex
2 puffs in each nostril once a day for 2 weeks
placeboDrug
Also called placebo comparator for Nasonex
2 puffs in each nostril once a day for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 2 weeks of treatment Receives: Drug: mometasone furoate nasal spray |
| 2 | Placebo comparator | 2 weeks of treatment Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Assessment
Global Assessment: 3=significantly improved, 2=moderately improved,
1=mildly improved, 0=no change, -1=mildly worse, -2=moderately worse, and -3=significantly worse
Measured: at week 2
Secondary outcomes (8)
Changes in RQLQ: Overall
The RQLQ is a disease-specific measure of a patient's quality of life. It includes domains that measure nasal and eye symptoms as well as those of activity, sleep, non-nasal/eye symptoms, practical and emotional measures. A scale of 0-6 is used to record the patient responses, with lower scores reflecting a better quality of life. The average score of each domain is calculated as well as an overall domain score reflecting the average of all scores.
Measured: Baseline and 2 weeks
Changes in RQLQ: Activity
The RQLQ activity range: 0-6. Higher scores indicate a worse quality of life.
Measured: Baseline and 2 weeks
Changes in RQLQ: Sleep
The RQLQ sleep range: 0-6. Higher scores indicate a worse quality of life.
Measured: Baseline and 2 weeks
Changes in RQLQ: Non-Nasal/Eye
The RQLQ non-nasal/eye range: 0-6. Higher scores indicate a worse quality of life.
Measured: Baseline and 2 weeks
Changes in RQLQ: Practical
The RQLQ practical range: 0-6. Higher scores indicate a worse quality of life.
Measured: Baseline and 2 weeks
Changes in RQLQ: Nasal
The RQLQ nasal range: 0-6. Higher scores indicate a worse quality of life.
Measured: Baseline and 2 weeks
Changes in RQLQ: Emotional
The RQLQ emotional range: 0-6. Higher scores indicate a worse quality of life.
Measured: Baseline and 2 weeks
Changes in RQLQ: Eye
The RQLQ eye range: 0-6. Higher scores indicate a worse quality of life.
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 posted20 Feb 2008 (estimated)
- Study startApr 2008
- Primary completionJul 2008
- Study completionJul 2010
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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Schering-Plough
- Responsible party
- Sponsor
- Investigators
- Robert M Naclerio, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00618332
- Sponsor's protocol ID
- 15624B
- Status last verified
- Jan 2014
- First submitted
- 6 Feb 2008
- Last updated
- 14 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Sharma S, Vasnani R, De Tineo M, Du G, Pinto JM, Baroody FM, Naclerio RM. Recruitment factors which affect the outcome of a seasonal allergic rhinitis trial. Allergy Asthma Proc. 2011 Jan-Feb;32(1):55-63. doi: 10.2500/aap.2011.32.3414.
PubMed 21262099
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Response to a Nasal Decongestant Test Predict the Outcome to Treatment of Seasonal Allergic Rhinitis With Nasonex?
- ClinicalTrials.gov ID
- NCT00618332
- Acronym / sponsor ID
- 15624B
- Conditions
- Seasonal Allergic Rhinitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Schering-Plough
- Study start
- Apr 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 20 Feb 2008 (estimated)
- Results
- Posted 10 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We hypothesize that those patients with purely seasonal allergic rhinitis will decongest better than those subjects with another cause contributing to their symptoms. These latter patients will not improve as well on an intranasal steroid as those who decongest well, potentially explaining the 60% response rate in prior studies.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: mometasone furoate nasal spray2 weeks of treatment |
| 2 | Placebo comparator | Drug: placebo2 weeks of treatment |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Males and females between 18 and 60 years of age.
- History of grass and/or ragweed allergic rhinitis.
- Positive skin or RAST test to grass, trees and/or ragweed antigen.
- Symptomatic at time of entry into study.
Key exclusion criteria (6 listed)
- Women of childbearing potential not using the contraception method(s) (Birth control pills, depo Provera, double barrier) as well as 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, neurological, oncologic or liver disease).
- Use of any other investigational agent in the last 30 days.
- Absence of nasal symptoms.
- Smoking.
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 |
|---|---|---|
| mometasone furoate nasal sprayAlso: Nasonex2 puffs in each nostril once a day for 2 weeks | Drug | 1 |
| placeboAlso: placebo comparator for Nasonex2 puffs in each nostril once a day for 2 weeks | Drug | 2 |
Primary outcome
Global Assessment
Time frame: at week 2
Global Assessment: 3=significantly improved, 2=moderately improved, 1=mildly improved, 0=no change, -1=mildly worse, -2=moderately worse, and -3=significantly worse
8 secondary outcomes
Changes in RQLQ: Overall
Time frame: Baseline and 2 weeks
Changes in RQLQ: Activity
Time frame: Baseline and 2 weeks
Changes in RQLQ: Sleep
Time frame: Baseline and 2 weeks
Changes in RQLQ: Non-Nasal/Eye
Time frame: Baseline and 2 weeks
Changes in RQLQ: Practical
Time frame: Baseline and 2 weeks
Changes in RQLQ: Nasal
Time frame: Baseline and 2 weeks
Changes in RQLQ: Emotional
Time frame: Baseline and 2 weeks
Changes in RQLQ: Eye
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 14 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21262099Sharma S, Vasnani R, De Tineo M, Du G, Pinto JM, Baroody FM, Naclerio RM. Recruitment factors which affect the outcome of a seasonal allergic rhinitis trial. Allergy Asthma Proc. 2011 Jan-Feb;32(1):55-63. doi: 10.2500/aap.2011.32.3414.
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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?
A study testing mometasone furoate nasal spray 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 4 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 14 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jan 2014). 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?
Global Assessment (time frame: at week 2). 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 NCT00618332, 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 14 Feb 2014.