Seasonal Allergic Rhinitis
Conditions
Brief summary
The investigators hypothesize that treatment with QNASL will reduce nasal mucosal inflammation induced by the allergy season and prevent the changes in the microbiome caused by the allergy season.
Interventions
DRUGQNASL
DRUGPlacebo nasal spray
Sponsors
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. Males and females between 18 and 55 years of age. 2. Two year history of seasonal allergic rhinitis. 3. Positive skin test to grass and/or tree antigen.
Exclusion criteria
1. Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease. 2. Pregnant or lactating women. 3. Subjects treated with systemic steroids during the previous 30 days. 4. Subjects treated with topical (inhaled, intranasal or intraocular) steroids, Nasalcrom or Opticrom during the previous 30 days. 5. Subjects treated with oral antihistamine/decongestants during the previous seven days. 6. Subjects treated with topical (intranasal or intraocular) antihistamine/decongestants during the previous 3 days. 7. Subjects treated with immunotherapy and are escalating their dose. 8. Subjects on chronic anti-asthma medications. 9. Subjects with polyps in the nose or a significantly displaced septum. 10. Upper respiratory infection within 14 days prior to study start.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Nasal Symptom Score (TNSS) | Two weeks following initiation of treatment | The Total Nasal Symptom Score (TNSS) is the sum of scores for each of nasal congestion, sneezing, nasal itching, and rhinorrhea using a four point scale (0-3), where 0 indicates no symptoms, a score of 1 for mild symptoms that are easily tolerated, 2 for awareness of symptoms which are bothersome but tolerable and 3 is reserved for severe symptoms that are hard to tolerate and interfere with daily activity. TNSS is calculated by adding the score for each of the symptoms to a total out of 12. TNSS was assessed daily and summed over 14 days; thus, the total score ranges from 0 to 168, with higher scores indicating a worse outcome. |
| Change in RQLQ Score From Baseline to Two Weeks | Two weeks following initiation of treatment | The Rhinoconjunctivitis Quality Of Life Questionnaire (RQLQ) is a self-administered disease-specific health-related quality of life instrument that measures the functional impairments that are most troublesome to adult patients as a result of their seasonal or perennial rhinoconjunctivitis of either allergic or non-allergic origin. There are 28 items each asking about symptoms during the previous week. Seven domains of activity limitation are included: activities (3 patient-specific) limitation, sleep problems (3 items), nose symptoms (4 items), eye symptoms (4 items), non-nose/eye symptoms (7 items), practical problems (3 items) and emotional function (4 items)). Each item is reported using a 7-point scale (0 = not impaired at all, 6 = severely impaired), and a total score is calculated by averaging over all items (range 0-7). Higher scores reflect lower quality of life. |
| Change in Percent Eosinophils From Baseline to Two Weeks | Two weeks following initiation of treatment | The percentage of nasal eosinophils recovered from nasal lavage was assessed at baseline and after two weeks of treatment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| QNASL Nasal Spray QNASL 320 mcg once-daily administered as two sprays in each nostril; 2 weeks of treatment
QNASL | 20 |
| Placebo Nasal Spray Placebo nasal spray once-daily administered as two sprays in each nostril; 2 weeks of treatment
Placebo nasal spray | 19 |
| Total | 39 |
Baseline characteristics
| Characteristic | Placebo Nasal Spray | Total | QNASL Nasal Spray |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 39 Participants | 20 Participants |
| Sex: Female, Male Female | 7 Participants | 16 Participants | 9 Participants |
| Sex: Female, Male Male | 12 Participants | 23 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 19 |
| other Total, other adverse events | 0 / 20 | 0 / 19 |
| serious Total, serious adverse events | 0 / 20 | 0 / 19 |
Outcome results
Primary
Change in Percent Eosinophils From Baseline to Two Weeks
The percentage of nasal eosinophils recovered from nasal lavage was assessed at baseline and after two weeks of treatment.
Time frame: Two weeks following initiation of treatment
Population: Those analyzed included all participants with data for this measure at baseline and two weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| QNASL Nasal Spray | Change in Percent Eosinophils From Baseline to Two Weeks | 1.5 Change in percentage of eosinophils | Standard Deviation 3.5 |
| Placebo Nasal Spray | Change in Percent Eosinophils From Baseline to Two Weeks | 2.1 Change in percentage of eosinophils | Standard Deviation 4.8 |
p-value: 0.778t-test, 2 sided
Primary
Change in RQLQ Score From Baseline to Two Weeks
The Rhinoconjunctivitis Quality Of Life Questionnaire (RQLQ) is a self-administered disease-specific health-related quality of life instrument that measures the functional impairments that are most troublesome to adult patients as a result of their seasonal or perennial rhinoconjunctivitis of either allergic or non-allergic origin. There are 28 items each asking about symptoms during the previous week. Seven domains of activity limitation are included: activities (3 patient-specific) limitation, sleep problems (3 items), nose symptoms (4 items), eye symptoms (4 items), non-nose/eye symptoms (7 items), practical problems (3 items) and emotional function (4 items)). Each item is reported using a 7-point scale (0 = not impaired at all, 6 = severely impaired), and a total score is calculated by averaging over all items (range 0-7). Higher scores reflect lower quality of life.
Time frame: Two weeks following initiation of treatment
Population: Those analyzed included all participants with data for this measure at baseline and two weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| QNASL Nasal Spray | Change in RQLQ Score From Baseline to Two Weeks | 1.2 Change in scale score | Standard Deviation 1.1 |
| Placebo Nasal Spray | Change in RQLQ Score From Baseline to Two Weeks | 1.3 Change in scale score | Standard Deviation 1.3 |
p-value: 0.789t-test, 2 sided
Primary
Total Nasal Symptom Score (TNSS)
The Total Nasal Symptom Score (TNSS) is the sum of scores for each of nasal congestion, sneezing, nasal itching, and rhinorrhea using a four point scale (0-3), where 0 indicates no symptoms, a score of 1 for mild symptoms that are easily tolerated, 2 for awareness of symptoms which are bothersome but tolerable and 3 is reserved for severe symptoms that are hard to tolerate and interfere with daily activity. TNSS is calculated by adding the score for each of the symptoms to a total out of 12. TNSS was assessed daily and summed over 14 days; thus, the total score ranges from 0 to 168, with higher scores indicating a worse outcome.
Time frame: Two weeks following initiation of treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| QNASL Nasal Spray | Total Nasal Symptom Score (TNSS) | 67.1 score on a scale | Standard Deviation 43.2 |
| Placebo Nasal Spray | Total Nasal Symptom Score (TNSS) | 78.0 score on a scale | Standard Deviation 34.3 |
p-value: 0.391t-test, 2 sided