Allergic RhinitisPhase 3NCT01231724
Topical Allstate and Nasal Allergen Challenge
A Phase 3 study testing Allstate Nasal Spray in people with Allergic Rhinitis, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of this study is to see whether Allstate Nasal Spray when given in the nose is safe and can reduce the signs and symptoms of allergic rhinitis (hayfever). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Allstate Nasal Spray
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Apr 2012
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Males and females between 18 and 55 years of age.
- History of grass and/or ragweed allergic rhinitis for at least 2 years.
- Positive skin test to grass and/or ragweed antigen within prior 12 months.
- Positive response to screening nasal challenge.
Who cannot join
- Respiratory disease other than allergic rhinitis, allergic conjunctivitis and mild asthma.
- Use of nasal steroids, antihistamines in the last 2 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).
- Having poorly tolerated previous administration of allergens
- Nasolacrimal drainage system malfunctions.
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- Participation in other investigational therapy in the last 30 days.
- Any systemic disorder or medication interfering with the study.
- FEV1<80% of predicted at screening for subjects with mild asthma.
- Presence of allergic rhinitis symptoms in the screening period with TNSS >3 at baseline)
- Undergoing allergen desensitization therapy.
- Current smokers or recent ex-smokers.
- 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 Randomized, Double-Blind, Placebo-Controlled, Cross-Over Trial of Topical Allstate in the Prevention of the Signs and Symptoms of the Acute Response to Nasal Allergen Challenge (CETALY0001)
The purpose of this study is to see whether Allstate Nasal Spray when given in the nose is safe and can reduce the signs and symptoms of allergic rhinitis (hayfever).
- Conditions
- Allergic Rhinitis
- Being tested
- Allstate Nasal Spray, Placebo Nasal Spray
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allstate Nasal SprayDevice
Allstate Nasal Spray, two sprays (total 100 microliters) in each nostril.
Placebo Nasal SprayDevice
2 sprays in each nostril
| Study group | Role | What they receive |
|---|---|---|
| Allstate Nasal Spray | Active comparator | Not described Receives: Device: Allstate Nasal Spray |
| Placebo Nasal Spray | Placebo comparator | Not described Receives: Device: Placebo Nasal Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of sneezes and total nasal symptom score (TNSS) (sum of nasal stuffiness, nasal discharge, and nasal itching) (scale 0-3 for each symptom; total score 0-9) are co-primary endpoints.
Measured: 10 minutes following each nasal challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2010 (estimated)
- Study startNov 2011
- Primary completionFeb 2012 (estimated)
- Study completionApr 2012 (estimated)
Why it stopped: study halted prematurely, prior to enrollment of first participant
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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
- Responsible party
- Principal investigator, Robert Naclerio, University of Chicago
- Investigators
- Robert M Naclerio, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01231724
- Sponsor's protocol ID
- 10-224-A
- Status last verified
- May 2013
- First submitted
- 28 Oct 2010
- Last updated
- 3 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Trial of Topical Allstate in the Prevention of the Signs and Symptoms of the Acute Response to Nasal Allergen Challenge (CETALY0001)
- ClinicalTrials.gov ID
- NCT01231724
- Acronym / sponsor ID
- 10-224-A
- Conditions
- Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study halted prematurely, prior to enrollment of first participant
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
- Study start
- Nov 2011
- Primary completion
- Feb 2012 (estimated)
- Study completion
- Apr 2012 (estimated)
- First posted
- 1 Nov 2010 (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 see whether Allstate Nasal Spray when given in the nose is safe and can reduce the signs and symptoms of allergic rhinitis (hayfever).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allstate Nasal Spray | Active comparator | Device: Allstate Nasal Spray |
| Placebo Nasal Spray | Placebo comparator | Device: Placebo Nasal Spray |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Males and females between 18 and 55 years of age.
- History of grass and/or ragweed allergic rhinitis for at least 2 years.
- Positive skin test to grass and/or ragweed antigen within prior 12 months.
- Positive response to screening nasal challenge.
Key exclusion criteria (15 listed)
- Respiratory disease other than allergic rhinitis, allergic conjunctivitis and mild asthma.
- Use of nasal steroids, antihistamines in the last 2 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).
- Having poorly tolerated previous administration of allergens
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 |
|---|---|---|
| Allstate Nasal SprayAllstate Nasal Spray, two sprays (total 100 microliters) in each nostril. | Device | Allstate Nasal Spray |
| Placebo Nasal Spray2 sprays in each nostril | Device | Placebo Nasal Spray |
Primary outcome
Number of sneezes and total nasal symptom score (TNSS) (sum of nasal stuffiness, nasal discharge, and nasal itching) (scale 0-3 for each symptom; total score 0-9) are co-primary endpoints.
Time frame: 10 minutes following each nasal challenge
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2013.
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Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
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Allergy, Asthma, and Atopic Eczema in Finland
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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 Phase 3 study testing Allstate Nasal Spray in people with 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 15 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: withdrawn, as of the sponsor's last update on 3 Jun 2013. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Number of sneezes and total nasal symptom score (TNSS) (sum of nasal stuffiness, nasal discharge, and nasal itching) (scale 0-3 for each symptom; total score 0-9) are co-primary endpoints. (time frame: 10 minutes following each nasal challenge). 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 3 Jun 2013; AzTrials last refreshed its copy on 1 Nov 2026.