Allergic Rhinitis
Conditions
Brief summary
The purpose of this study is to see whether ASP-1001 when given as a nasal spray is safe and can reduce the signs and symptoms of allergic rhinitis (hayfever) following nasal challenge with antigen.
Interventions
DRUGASP-1001 nasal spray
2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.
DRUGPlacebo for ASP-1001
2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.
Sponsors
Asphelia Pharmaceuticals
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 Days to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Males and females between 18 and 55 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 or sinusitis within 14 days of study start. 4. Use of nasal steroids, antihistamines in the last 2 weeks. 5. FEV1\<80% of predicted at screening for subjects with history of mild asthma 6. current smokers or recent ex-smokers 7. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sneezing Symptom | 10 minutes after diluent challenge and 10 minutes after each antigen challenge | Sneezes. The change is calculated by adding the number of sneezes following both antigen challenges minus twice the number of sneezes after the diluent challenge. |
| Change in Runny Nose Symptom | 10 minutes after diluent challenge and 10 minutes after each antigen challenge | The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of runny nose following both antigen challenges minus twice the score of runny nose after the diluent challenge. |
| Change in Stuffy Nose Symptom | 10 minutes after diluent challenge and 10 minutes after each antigen challenge | The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of stuffy nose following both antigen challenges minus twice the score of stuffy nose after the diluent challenge. |
| Change in Itching Symptom | 10 minutes after diluent challenge and 10 minutes after each antigen challenge | The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of itchy nose following both antigen challenges minus twice the score of itchy nose after the diluent challenge. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nasal Peak Inspiratory Flow Measurements | 15 minutes after diluent challenge and 15 minutes after each antigen challenge | The value of nasal peak inspiratory flow. The change is calculated by adding the values of nasal peak inspiratory flow following both antigen challenges minus twice the value of nasal peak inspiratory flow after the diluent challenge. |
| Change in Nasal Peak Inspiratory Flow Measurements From Before to After Treatment | 15 minutes prior to treatment and 15 minutes post antigen challenges | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age Continuous | 33 years STANDARD_DEVIATION 9.4 |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Change in Itching Symptom
The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of itchy nose following both antigen challenges minus twice the score of itchy nose after the diluent challenge.
Time frame: 10 minutes after diluent challenge and 10 minutes after each antigen challenge
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Topical ASP-1001 | Change in Itching Symptom | 0 units on a scale |
| Placebo for Topical ASP-1001 | Change in Itching Symptom | 1 units on a scale |
Primary
Change in Runny Nose Symptom
The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of runny nose following both antigen challenges minus twice the score of runny nose after the diluent challenge.
Time frame: 10 minutes after diluent challenge and 10 minutes after each antigen challenge
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Topical ASP-1001 | Change in Runny Nose Symptom | 1 units on a scale |
| Placebo for Topical ASP-1001 | Change in Runny Nose Symptom | 2.5 units on a scale |
Primary
Change in Sneezing Symptom
Sneezes. The change is calculated by adding the number of sneezes following both antigen challenges minus twice the number of sneezes after the diluent challenge.
Time frame: 10 minutes after diluent challenge and 10 minutes after each antigen challenge
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Topical ASP-1001 | Change in Sneezing Symptom | 1 sneezes |
| Placebo for Topical ASP-1001 | Change in Sneezing Symptom | 1 sneezes |
Primary
Change in Stuffy Nose Symptom
The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of stuffy nose following both antigen challenges minus twice the score of stuffy nose after the diluent challenge.
Time frame: 10 minutes after diluent challenge and 10 minutes after each antigen challenge
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Topical ASP-1001 | Change in Stuffy Nose Symptom | 1 units on a scale |
| Placebo for Topical ASP-1001 | Change in Stuffy Nose Symptom | 2 units on a scale |
Secondary
Change in Nasal Peak Inspiratory Flow Measurements From Before to After Treatment
Time frame: 15 minutes prior to treatment and 15 minutes post antigen challenges
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Topical ASP-1001 | Change in Nasal Peak Inspiratory Flow Measurements From Before to After Treatment | -7.5 L/min |
| Placebo for Topical ASP-1001 | Change in Nasal Peak Inspiratory Flow Measurements From Before to After Treatment | -10 L/min |
Secondary
Nasal Peak Inspiratory Flow Measurements
The value of nasal peak inspiratory flow. The change is calculated by adding the values of nasal peak inspiratory flow following both antigen challenges minus twice the value of nasal peak inspiratory flow after the diluent challenge.
Time frame: 15 minutes after diluent challenge and 15 minutes after each antigen challenge
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Topical ASP-1001 | Nasal Peak Inspiratory Flow Measurements | -8.5 L/min |
| Placebo for Topical ASP-1001 | Nasal Peak Inspiratory Flow Measurements | -30 L/min |