Allergic RhinitisNCT01723397
Effect of Nasaleze on Nasal Challenge With Allergen
A study testing Nasaleze Spray and Allergen in people with Allergic Rhinitis, run by University of Chicago at 1 site in United States.
Trial summary
The objectives of this protocol are: 1. to confirm the inhibitory effect of Nasaleze on the immediate response to nasal challenge with antigen, and 2. to show that inhibition of the immediate response to nasal challenge with antigen by Nasaleze inhibits subsequent inflammatory events. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Nasaleze Spray and Allergen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Jul 2014
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females between 18 and 45 years of age.
- History of grass and/or ragweed allergic rhinitis.
- Positive skin test to grass and/or ragweed antigen.
- Positive response to screening nasal challenge.
Who cannot join
- Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
- Pregnant or lactating women.
- Upper respiratory infection within 14 days of study start.
- FEV1<80% of predicted at screening for subjects with history of mild asthma.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Nasaleze on the Early Reaction to Nasal Challenge With Allergen
The objectives of this protocol are:
- to confirm the inhibitory effect of Nasaleze on the immediate response to nasal challenge with antigen, and
- to show that inhibition of the immediate response to nasal challenge with antigen by Nasaleze inhibits subsequent inflammatory events.
- Conditions
- Allergic Rhinitis
- Being tested
- Nasaleze Spray, Placebo spray, Allergen
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasaleze SprayDrug
Subjects are treated with over the counter Nasaleze cellulose powder nasal spray then challenged with allergen
Placebo sprayOther
Subjects are treated with placebo nasal spray then challenged with allergen
AllergenBiological
Subjects are challenged with grass or ragweed allergen after treatment with Nasaleze or placebo
| Study group | Role | What they receive |
|---|---|---|
| Nasaleze spray | Active comparator | Nasaleze spray 1 puff via "spray device" in each nostril 3 times daily for 1 week followed by allergen challenge Receives: Drug: Nasaleze Spray; Biological: Allergen |
| Placebo spray | Placebo comparator | Placebo spray 1 puff via "spray device" in each nostril 3 times daily for 1 week followed by allergen challenge Receives: Other: Placebo spray; Biological: Allergen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Nasal Symptom Score After Nasal Challenge With Allergen Versus Diluent
Change in total nasal symptom score after nasal challenges (the change is calculated as the total nasal symptom score after allergen challenge - total nasal symptom score after diluent challenge) on the second of two days of nasal challenges following one week of pretreatment with Nasaleze or placebo. The nasal symptoms included number of sneezes, symptoms of runny and stuffy nose (separately for each nostril), and itchy nose/throat symptoms. Individual symptoms were score on a scale from 0-3 (0=no symptoms, 1=mild, 2=moderate, 3=severe). The maximum total nasal symptom score possible was 15 with higher scores indicating worse symptoms.
Measured: Day 2 after one week pretreatment with Nasaleze or placebo.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionJul 2014
- Study completionJul 2014
Why it stopped: Poor recruitment
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 14 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
- NCT01723397
- Sponsor's protocol ID
- 12-1252
- Status last verified
- Nov 2016
- First submitted
- 5 Nov 2012
- Last updated
- 2 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nasaleze on the Early Reaction to Nasal Challenge With Allergen
- ClinicalTrials.gov ID
- NCT01723397
- Acronym / sponsor ID
- 12-1252
- Conditions
- Allergic Rhinitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor recruitment
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 7 Nov 2012 (estimated)
- Results
- Posted 27 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this protocol are:
- to confirm the inhibitory effect of Nasaleze on the immediate response to nasal challenge with antigen, and
- to show that inhibition of the immediate response to nasal challenge with antigen by Nasaleze inhibits subsequent inflammatory events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasaleze spray | Active comparator | Drug: Nasaleze Spray, Biological: AllergenNasaleze spray 1 puff via "spray device" in each nostril 3 times daily for 1 week followed by allergen challenge |
| Placebo spray | Placebo comparator | Other: Placebo spray, Biological: AllergenPlacebo spray 1 puff via "spray device" in each nostril 3 times daily for 1 week followed by allergen challenge |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Males and females between 18 and 45 years of age.
- History of grass and/or ragweed allergic rhinitis.
- Positive skin test to grass and/or ragweed antigen.
- Positive response to screening nasal challenge.
Key exclusion criteria (4 listed)
- Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
- Pregnant or lactating women.
- Upper respiratory infection within 14 days of study start.
- FEV1<80% of predicted at screening for subjects with history of mild asthma.
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 |
|---|---|---|
| Nasaleze SpraySubjects are treated with over the counter Nasaleze cellulose powder nasal spray then challenged with allergen | Drug | Nasaleze spray |
| Placebo spraySubjects are treated with placebo nasal spray then challenged with allergen | Other | Placebo spray |
| AllergenSubjects are challenged with grass or ragweed allergen after treatment with Nasaleze or placebo | Biological | Nasaleze spray, Placebo spray |
Primary outcome
Change in Total Nasal Symptom Score After Nasal Challenge With Allergen Versus Diluent
Time frame: Day 2 after one week pretreatment with Nasaleze or placebo.
Change in total nasal symptom score after nasal challenges (the change is calculated as the total nasal symptom score after allergen challenge - total nasal symptom score after diluent challenge) on the second of two days of nasal challenges following one week of pretreatment with Nasaleze or placebo. The nasal symptoms included number of sneezes, symptoms of runny and stuffy nose (separately for each nostril), and itchy nose/throat symptoms. Individual symptoms were score on a scale from 0-3 (0=no symptoms, 1=mild, 2=moderate, 3=severe). The maximum total nasal symptom score possible was 15 with higher scores indicating worse symptoms.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
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A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)
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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 Nasaleze Spray and Allergen 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 4 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 2 Jan 2017. 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 27 Oct 2016). 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?
Change in Total Nasal Symptom Score After Nasal Challenge With Allergen Versus Diluent (time frame: Day 2 after one week pretreatment with Nasaleze or placebo.). 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 2 Jan 2017; AzTrials last refreshed its copy on 7 Nov 2026.