Allergic Rhinitis
Conditions
Brief 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.
Interventions
DRUGNasaleze Spray
Subjects are treated with over the counter Nasaleze cellulose powder nasal spray then challenged with allergen
OTHERPlacebo spray
Subjects are treated with placebo nasal spray then challenged with allergen
BIOLOGICALAllergen
Subjects are challenged with grass or ragweed allergen after treatment with Nasaleze or placebo
Sponsors
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Males and females between 18 and 45 years of age. 2. History of grass and/or ragweed allergic rhinitis. 3. Positive skin test to grass and/or ragweed antigen. 4. Positive response to screening nasal challenge.
Exclusion criteria
1. Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease. 2. Pregnant or lactating women. 3. Upper respiratory infection within 14 days of study start. 4. FEV1\<80% of predicted at screening for subjects with history of mild asthma.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Nasal Symptom Score After Nasal Challenge With Allergen Versus Diluent | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nasaleze Spray, Then Placebo Spray This group first received Nasaleze spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen (either grass or ragweed) challenge, then after a 1 week washout received placebo spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen challenge | 7 |
| Placebo Spray, Then Nasaleze Spray This group first received placebo spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen (either grass or ragweed) challenge, then after a 1 week washout received Nasaleze spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen challenge | 7 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Study Period 1 | Protocol Violation | 0 | 1 |
| Study Period 2 | Protocol Violation | 0 | 1 |
Baseline characteristics
| Characteristic | Nasaleze Spray, Then Placebo Spray | Placebo Spray, Then Nasaleze Spray | Total |
|---|---|---|---|
| Age, Continuous | 23.6 years STANDARD_DEVIATION 8.6 | 28.0 years STANDARD_DEVIATION 7.5 | 25.8 years STANDARD_DEVIATION 8.1 |
| Gender Female | 5 Participants | 4 Participants | 9 Participants |
| Gender Male | 2 Participants | 3 Participants | 5 Participants |
| Region of Enrollment United States | 7 participants | 7 participants | 14 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 14 | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 |
Outcome results
Primary
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.
Time frame: Day 2 after one week pretreatment with Nasaleze or placebo.
Population: The analysis population includes the 12 participants who completed the study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nasaleze Spray | Change in Total Nasal Symptom Score After Nasal Challenge With Allergen Versus Diluent | 5.5 units on a scale |
| Placebo Spray | Change in Total Nasal Symptom Score After Nasal Challenge With Allergen Versus Diluent | 5.5 units on a scale |
p-value: 0.8Wilcoxon signed-rank test