Seasonal Allergic Rhinitis
Conditions
Brief summary
The purpose of this study was to determine if two allergy medications are more effective than placebo.
Interventions
DRUG0.15% azelastine hydrochloride 1644 mcg daily
0.15% azelastine hydrochloride 1644 mcg daily
DRUG0.1% azelastine hydrochloride 1096 mcg daily
0.1% azelastine hydrochloride 1096 mcg daily
DRUGPlacebo
0 mcg Placebo daily
Sponsors
Meda Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male and female patients 12 years of age and older 2. Provide written informed consent/pediatric assent. If the patient is a minor, a parent or legal guardian must give written informed consent 3. Screening Visit: Have a 12-hour reflective TNSS of at least 8 out of a possible 12 and a congestion score of 2 or 3 on Day -7 4. Randomization Visit: Have a 12-hour reflective TNSS (AM or PM) of at least 8 on 3 separate symptom assessments (one of which was within 2 days of Day 1, and can include the morning of Day 1) during the Lead-in Period. In addition, an AM or PM 12-hour reflective nasal congestion score of 2 or 3 must have been recorded on 3 separate symptom assessments (one of which was within 2 days of Day 1, and can include the morning of Day 1) 5. Randomization Visit: An instantaneous TNSS of ≥ 8 before beginning the onset of action assessment on Day 1 6. Must have taken at least 10 doses of study medication during the lead-in period 7. Willing and able to comply with the study requirements 8. At least a 2-year history of SAR 9. The presence of IgE-mediated hypersensitivity to ragweed antigen or other local fall allergens, confirmed by a positive response to either skin prick within the last year. A positive response is defined as a wheal diameter of at least 3 mm larger than the negative control for the skin prick test. 10. General good health and free of any disease or concomitant treatment that could interfere with the interpretation of the study results as determined by the investigator or the sponsor's medical officer. When in doubt, the investigator should confer with the sponsor's medical monitor or designee to determine eligibility for the study. 11. Patients receiving immunotherapy injections (antigen desensitization) must be on a stable maintenance regimen for at least 30 days before the first study visit (adjustments to regimen following a brief period of missed injections does not preclude participation). Patients currently receiving sublingual immunotherapy are excluded. A 6-month washout period is required following the last dose of sublingual immunotherapy.
Exclusion criteria
1. On Focused Nasal Examination, the presence of any nasal mucosal erosion, nasal ulceration, or nasal septal perforation at either the screening visit or randomization visit will disqualify the patient from the study. 2. Other nasal disease(s) likely such as sinusitis, rhinitis medicamentosa, clinically significant polyposis, or nasal structural abnormalities. 3. Nasal surgery or sinus surgery within the previous year. 4. Chronic sinusitis - more than 3 episodes per year 5. Planned travel outside of the study area during the study period 6. The use of any investigational drug within 30 days prior to Day -7. No investigational products are permitted for use during the conduct of this study 7. Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitol or sucralose (Splenda® brand sweetener) 8. Women who are pregnant or nursing 9. Women of childbearing potential who are not abstinent or not practicing a medically acceptable method of contraception 10. Respiratory Tract Infections within 14 days prior to Day -7 11. Respiratory Tract Infections requiring oral antibiotic within 14 days of Day -7 12. Asthma (with the exception of mild, intermittent asthma). Patients with mild, intermittent asthma who only require short-acting inhaled bronchodilators are eligible for enrollment. 13. Significant pulmonary disease including COPD 14. Clinically significant arrhythmia or with symptomatic cardiac conditions 15. A known history of alcohol or drug abuse 16. Existence of any surgical or medical condition or physical or laboratory findings, which in the opinion of the investigator or sponsor's medical monitor, might significantly alter the absorption, distribution, metabolism, or excretion of study drug or that might significantly affect the patient's ability to complete this trial. 17. Clinically relevant abnormal physical findings within 1 week of randomization which, in the opinion of the investigator, would interfere with the objectives of the study or that may preclude compliance with the study procedures 18. Participation in MedPointe Protocols MP433, MP434, MP435, or MP436. 19. Employees of the research center or private practice and their family members are excluded 20. Patients who received prohibited medications within specified timepoints in the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in 12-hour Reflective Total Nasal Symptom Score(rTNSS)for the Entire 14-day Study Period Compared to Placebo | baseline and 14 days | rTNSS consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. (maximum 12 points per assessment.) Total possible score is 24 per day. Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and baseline as a covariate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Instantaneous Total Nasal Symptom Score for the Entire 14-day Study Period Compared to Placebo | baseline and 14 Days | instantaneous (subjects rate how they feel right now) total nasal symptom score consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day. Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate. |
| Change From Baseline in the 12-hour Reflective Secondary Symptom Complex Score for the Entire 14-day Study Period Compared to Placebo | baseline and 14 days | Reflective secondary symptom scores (SSCS) (post-nasal drip, itchy eyes, cough and headache) were assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible SSCS score is 24 per day. Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate. |
| Change From Baseline to Day 14 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Patients 18 Years of Age and Older | baseline and 14 days | A 28-item RQLQ was completed on Day 1 and Day 14 or Early temination. The RQLQ consists of 7 domains rated on a 7 point scale with 0 being not troubled by the allergy symptoms, and 6 being extremely troubled/all of the time. Domain score will be calculated from the mean score of all items in the domain. Overall score will be calculated from the mean score of all items. |
| Change From Baseline on Direct Visual Nasal Exams | 14 days | Examination of head and neck (scale: None, Mild, Moderate, Severe) for Epistaxis, Mucosal Edema, Nasal Discharge, Mucosal erythema, Mucosal Bleeding, and Crusting of mucosa. Nasal irratation was rated: 0 = None, Grade 1A = focal irritation, Grade 1B = superficial mucosal erosion, Grade 2 = moderate mucosal erosion, Grade 3 = ulceration, Grade 4 = septal perforation |
Countries
United States
Participant flow
Recruitment details
First observation: 14 Aug 2007 Last observation: 19 Nov 2007
Pre-assignment details
Subjects participated in a 7 day screening period to Identify appropriate subjects based on symptom scores.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo Nasal Spray taken 2 sprays per nostril twice a day for 14 days | 177 |
| Astepro 0.1% 0.1% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days | 169 |
| Astepro 0.15% 0.15% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days | 177 |
| Total | 523 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 5 | 3 | 4 |
| Overall Study | eligibility criteria violation | 1 | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 |
| Overall Study | Non-compliance | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Astepro 0.1% | Astepro 0.15% | Placebo | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 16 Participants | 16 Participants | 24 Participants | 56 Participants |
| Age, Categorical >=65 years | 2 Participants | 5 Participants | 5 Participants | 12 Participants |
| Age, Categorical Between 18 and 65 years | 151 Participants | 156 Participants | 148 Participants | 455 Participants |
| Age Continuous | 35.4 years STANDARD_DEVIATION 13.74 | 37.7 years STANDARD_DEVIATION 14.64 | 36.9 years STANDARD_DEVIATION 14.27 | 36.7 years STANDARD_DEVIATION 14.23 |
| Region of Enrollment United States | 169 participants | 177 participants | 177 participants | 523 participants |
| Sex: Female, Male Female | 111 Participants | 107 Participants | 116 Participants | 334 Participants |
| Sex: Female, Male Male | 58 Participants | 70 Participants | 61 Participants | 189 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 5 / 178 | 21 / 170 | 19 / 178 |
| serious Total, serious adverse events | 2 / 178 | 0 / 170 | 0 / 178 |
Outcome results
Primary
Change From Baseline in 12-hour Reflective Total Nasal Symptom Score(rTNSS)for the Entire 14-day Study Period Compared to Placebo
rTNSS consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. (maximum 12 points per assessment.) Total possible score is 24 per day. Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and baseline as a covariate.
Time frame: baseline and 14 days
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in 12-hour Reflective Total Nasal Symptom Score(rTNSS)for the Entire 14-day Study Period Compared to Placebo | Overall change from baseline | -2.36 total nasal symptom score | Standard Deviation 4.155 |
| Placebo | Change From Baseline in 12-hour Reflective Total Nasal Symptom Score(rTNSS)for the Entire 14-day Study Period Compared to Placebo | Baseline symptom score | 17.86 total nasal symptom score | Standard Deviation 3.301 |
| Astepro 0.1% | Change From Baseline in 12-hour Reflective Total Nasal Symptom Score(rTNSS)for the Entire 14-day Study Period Compared to Placebo | Overall change from baseline | -4.42 total nasal symptom score | Standard Deviation 4.696 |
| Astepro 0.1% | Change From Baseline in 12-hour Reflective Total Nasal Symptom Score(rTNSS)for the Entire 14-day Study Period Compared to Placebo | Baseline symptom score | 18.29 total nasal symptom score | Standard Deviation 3.23 |
| Astepro 0.15% | Change From Baseline in 12-hour Reflective Total Nasal Symptom Score(rTNSS)for the Entire 14-day Study Period Compared to Placebo | Baseline symptom score | 17.83 total nasal symptom score | Standard Deviation 3.284 |
| Astepro 0.15% | Change From Baseline in 12-hour Reflective Total Nasal Symptom Score(rTNSS)for the Entire 14-day Study Period Compared to Placebo | Overall change from baseline | -5.36 total nasal symptom score | Standard Deviation 5.077 |
Comparison: Change in baseline to Day 14p-value: <0.00195% CI: [-2.98, -1.14]ANCOVA
Comparison: Change in baseline to Day 14p-value: <0.00195% CI: [-3.91, -2.09]ANCOVA
Secondary
Change From Baseline in Instantaneous Total Nasal Symptom Score for the Entire 14-day Study Period Compared to Placebo
instantaneous (subjects rate how they feel right now) total nasal symptom score consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day. Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate.
Time frame: baseline and 14 Days
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Instantaneous Total Nasal Symptom Score for the Entire 14-day Study Period Compared to Placebo | Baseline symptom score | 16.56 total nasal symptom score | Standard Deviation 3.962 |
| Placebo | Change From Baseline in Instantaneous Total Nasal Symptom Score for the Entire 14-day Study Period Compared to Placebo | Overall change from baseline | -1.96 total nasal symptom score | Standard Deviation 4.313 |
| Astepro 0.1% | Change From Baseline in Instantaneous Total Nasal Symptom Score for the Entire 14-day Study Period Compared to Placebo | Baseline symptom score | 17.22 total nasal symptom score | Standard Deviation 3.836 |
| Astepro 0.1% | Change From Baseline in Instantaneous Total Nasal Symptom Score for the Entire 14-day Study Period Compared to Placebo | Overall change from baseline | -3.74 total nasal symptom score | Standard Deviation 4.796 |
| Astepro 0.15% | Change From Baseline in Instantaneous Total Nasal Symptom Score for the Entire 14-day Study Period Compared to Placebo | Baseline symptom score | 16.43 total nasal symptom score | Standard Deviation 3.998 |
| Astepro 0.15% | Change From Baseline in Instantaneous Total Nasal Symptom Score for the Entire 14-day Study Period Compared to Placebo | Overall change from baseline | -4.63 total nasal symptom score | Standard Deviation 5.261 |
Comparison: Change in baseline to Day 14p-value: <0.00195% CI: [-2.72, -0.84]ANCOVA
Comparison: Change in baseline to Day 14p-value: <0.00195% CI: [-3.6, -1.74]ANCOVA
Secondary
Change From Baseline in the 12-hour Reflective Secondary Symptom Complex Score for the Entire 14-day Study Period Compared to Placebo
Reflective secondary symptom scores (SSCS) (post-nasal drip, itchy eyes, cough and headache) were assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible SSCS score is 24 per day. Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate.
Time frame: baseline and 14 days
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the 12-hour Reflective Secondary Symptom Complex Score for the Entire 14-day Study Period Compared to Placebo | Baseline SSCS | 14.27 Reflective secondary symptom score | Standard Deviation 4.503 |
| Placebo | Change From Baseline in the 12-hour Reflective Secondary Symptom Complex Score for the Entire 14-day Study Period Compared to Placebo | Change in baseline to Day 14 | -1.72 Reflective secondary symptom score | Standard Deviation 3.823 |
| Astepro 0.1% | Change From Baseline in the 12-hour Reflective Secondary Symptom Complex Score for the Entire 14-day Study Period Compared to Placebo | Baseline SSCS | 14.59 Reflective secondary symptom score | Standard Deviation 4.818 |
| Astepro 0.1% | Change From Baseline in the 12-hour Reflective Secondary Symptom Complex Score for the Entire 14-day Study Period Compared to Placebo | Change in baseline to Day 14 | -3.09 Reflective secondary symptom score | Standard Deviation 4.337 |
| Astepro 0.15% | Change From Baseline in the 12-hour Reflective Secondary Symptom Complex Score for the Entire 14-day Study Period Compared to Placebo | Baseline SSCS | 13.59 Reflective secondary symptom score | Standard Deviation 5.087 |
| Astepro 0.15% | Change From Baseline in the 12-hour Reflective Secondary Symptom Complex Score for the Entire 14-day Study Period Compared to Placebo | Change in baseline to Day 14 | -4.15 Reflective secondary symptom score | Standard Deviation 4.6 |
Comparison: Change in baseline to Day 14p-value: 0.00195% CI: [-2.2, -0.56]ANCOVA
Comparison: Change in baseline to Day 14p-value: <0.00195% CI: [-3.24, -1.62]ANCOVA
Secondary
Change From Baseline on Direct Visual Nasal Exams
Examination of head and neck (scale: None, Mild, Moderate, Severe) for Epistaxis, Mucosal Edema, Nasal Discharge, Mucosal erythema, Mucosal Bleeding, and Crusting of mucosa. Nasal irratation was rated: 0 = None, Grade 1A = focal irritation, Grade 1B = superficial mucosal erosion, Grade 2 = moderate mucosal erosion, Grade 3 = ulceration, Grade 4 = septal perforation
Time frame: 14 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Mucosal Edema: screening - Total | 178 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Epistaxis: Day 14/ET - Moderate | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Mucosal Erythema: Day 14/ET - Toal | 178 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Mucosal Edema: screening - None | 3 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Crusting of Mucosa: Day 14/ET - None | 154 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Mucosal Erythema: screening - Severe | 1 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Mucosal Edema: screening - Mild | 40 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Crusting of Mucosa: screening - Total | 178 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Mucosal Erythema: screening - Moderate | 37 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Mucosal Edema: screening - Moderate | 108 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Epistaxis: Day 14/ET - Severe | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Mucosal Erythema: screening - Mild | 59 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Mucosal Edema: screening - Severe | 27 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Epistaxis: screening - Moderate | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Mucosal Erythema: screening - None | 81 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Mucosal Edema: Day 14/ET - total | 178 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Nasal Discharge: screening - Moderate | 64 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Mucosal Erythema: screening - Total | 178 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Mucosal Edema: Day 14/ET - None | 14 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Nasal Irritation: screening - total | 178 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Nasal Discharge: Day 14/ET - Severe | 10 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Mucosal Edema: Day 14/ET - Mild | 50 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Epistaxis: screening - None | 176 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Nasal Discharge: Day 14/ET - Moderate | 47 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Mucosal Edema: Day 14/ET - Moderate | 88 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Mucosal Bleeding: Day 14/ET - Severe | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Nasal Discharge: Day 14/ET- Mild | 85 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Mucosal Edema: Day 14/ET - Severe | 26 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Nasal Irritation: screening - None | 169 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Nasal Discharge: Day 14/ET - None | 26 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Nasal Discharge: screening - Total | 178 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Crusting of Mucosa: Day 14/ET - Total | 178 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Nasal Discharge: Day 14/ET - Total | 178 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Nasal Discharge: screening - Severe | 13 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Nasal Discharge: screening - None | 29 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Mucosal Bleeding: Day 14/ET - Moderate | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Crusting of Mucosa: Day 14/ET - Moderate | 4 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Nasal Discharge: screening - Mild | 72 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Nasal Irritation: screening - Grade 1A | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Epistaxis: screening - Severe | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Mucosal Bleeding: Day 14/ET - Mild | 7 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Nasal Irritation: screening - Grade 1B | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Epistaxis: screening - total | 178 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Mucosal Bleeding: Day 14/ET - None | 171 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Nasal Irritation: screening - Grade 2 | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Crusting of Mucosa: screening - Severe | 1 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Mucosal Bleeding: Day 14/ET - Total | 178 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Nasal Irritation: screening - Grade 3 | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Epistaxis: Day 14/ET - total | 178 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Mucosal Bleeding: screening - Severe | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Nasal Irritation: screening - Grade 4 | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Crusting of Mucosa: Day 14/ET - Mild | 19 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Mucosal Bleeding: screening - Moderate | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Nasal Irritation: Day 14/ET - Total | 178 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Crusting of Mucosa: screening - Moderate | 4 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Mucosal Bleeding: screening - Mild | 3 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Nasal Irritation: Day 14/ET - None | 168 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Epistaxis: Day 14/ET - None | 174 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Mucosal Bleeding: screening - None | 175 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Nasal Irritation: Day 14/ET- Grade 1A | 8 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Epistaxis: screening - Mild | 2 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Mucosal Bleeding: screening - Toal | 178 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Nasal Irritation: Day 14/ET- Grade 1B | 2 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Crusting of Mucosa: screening - Mild | 17 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Mucosal Erythema: Day 14/ET - Severe | 1 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Nasal Irritation: Day 14/ET- Grade 2 | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Epistaxis: Day 14/ET - Mild | 4 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Mucosal Erythema: Day 14/ET - Moderate | 25 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Nasal Irritation: Day 14/ET- Grade 3 | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Crusting of Mucosa: Day 14/ET - Severe | 1 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Mucosal Erythema: Day 14/ET - Mild | 51 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Nasal Irritation: Day 14/ET- Grade 4 | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Crusting of Mucosa: screening - None | 156 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams | Mucosal Erythema: Day 14/ET - None | 101 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Bleeding: Day 14/ET - Severe | 0 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Crusting of Mucosa: Day 14/ET - Severe | 0 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Epistaxis: screening - total | 170 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Epistaxis: screening - None | 169 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Epistaxis: screening - Mild | 1 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Epistaxis: screening - Moderate | 0 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Epistaxis: screening - Severe | 0 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Epistaxis: Day 14/ET - total | 169 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Epistaxis: Day 14/ET - None | 168 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Epistaxis: Day 14/ET - Mild | 1 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Epistaxis: Day 14/ET - Moderate | 0 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Epistaxis: Day 14/ET - Severe | 0 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Nasal Irritation: screening - total | 0 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Nasal Irritation: screening - None | 170 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Nasal Irritation: screening - Grade 1A | 166 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Nasal Irritation: screening - Grade 1B | 4 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Nasal Irritation: screening - Grade 2 | 0 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Nasal Irritation: screening - Grade 3 | 0 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Nasal Irritation: screening - Grade 4 | 0 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Nasal Irritation: Day 14/ET - Total | 169 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Nasal Irritation: Day 14/ET - None | 161 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Nasal Irritation: Day 14/ET- Grade 1A | 8 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Nasal Irritation: Day 14/ET- Grade 1B | 0 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Nasal Irritation: Day 14/ET- Grade 2 | 0 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Nasal Irritation: Day 14/ET- Grade 3 | 0 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Nasal Irritation: Day 14/ET- Grade 4 | 0 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Edema: screening - Total | 170 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Edema: screening - None | 3 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Edema: screening - Mild | 30 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Edema: screening - Moderate | 106 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Edema: screening - Severe | 31 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Edema: Day 14/ET - total | 169 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Edema: Day 14/ET - None | 12 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Edema: Day 14/ET - Mild | 60 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Edema: Day 14/ET - Moderate | 77 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Edema: Day 14/ET - Severe | 20 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Nasal Discharge: screening - Total | 170 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Nasal Discharge: screening - None | 26 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Nasal Discharge: screening - Mild | 63 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Nasal Discharge: screening - Moderate | 67 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Nasal Discharge: screening - Severe | 14 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Nasal Discharge: Day 14/ET - Total | 169 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Nasal Discharge: Day 14/ET - None | 46 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Nasal Discharge: Day 14/ET- Mild | 71 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Nasal Discharge: Day 14/ET - Moderate | 46 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Nasal Discharge: Day 14/ET - Severe | 6 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Erythema: screening - Total | 170 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Erythema: screening - None | 74 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Erythema: screening - Mild | 56 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Erythema: screening - Moderate | 37 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Crusting of Mucosa: Day 14/ET - Moderate | 2 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Erythema: screening - Severe | 3 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Erythema: Day 14/ET - Toal | 167 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Erythema: Day 14/ET - None | 97 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Erythema: Day 14/ET - Mild | 49 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Erythema: Day 14/ET - Moderate | 18 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Erythema: Day 14/ET - Severe | 5 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Bleeding: screening - Toal | 170 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Bleeding: screening - None | 167 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Bleeding: screening - Mild | 3 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Bleeding: screening - Moderate | 0 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Bleeding: screening - Severe | 0 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Bleeding: Day 14/ET - Total | 169 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Bleeding: Day 14/ET - None | 163 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Bleeding: Day 14/ET - Mild | 6 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Bleeding: Day 14/ET - Moderate | 0 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Crusting of Mucosa: screening - Total | 170 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Crusting of Mucosa: screening - None | 142 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Crusting of Mucosa: screening - Mild | 20 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Crusting of Mucosa: screening - Moderate | 7 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Crusting of Mucosa: screening - Severe | 1 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Crusting of Mucosa: Day 14/ET - Total | 169 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Crusting of Mucosa: Day 14/ET - None | 148 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams | Crusting of Mucosa: Day 14/ET - Mild | 19 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Edema: screening - None | 3 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Crusting of Mucosa: screening - Total | 178 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Epistaxis: Day 14/ET - Mild | 9 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Erythema: screening - Severe | 2 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Edema: screening - Total | 178 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Crusting of Mucosa: Day 14/ET - Moderate | 3 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Erythema: Day 14/ET - Toal | 175 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Nasal Irritation: Day 14/ET- Grade 4 | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Crusting of Mucosa: screening - None | 158 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Erythema: Day 14/ET - None | 105 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Nasal Irritation: Day 14/ET- Grade 3 | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Epistaxis: Day 14/ET - None | 166 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Erythema: Day 14/ET - Mild | 42 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Nasal Irritation: Day 14/ET- Grade 2 | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Crusting of Mucosa: Day 14/ET - None | 155 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Erythema: Day 14/ET - Moderate | 27 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Nasal Irritation: Day 14/ET- Grade 1B | 3 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Crusting of Mucosa: screening - Mild | 18 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Nasal Irritation: Day 14/ET- Grade 1A | 7 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Epistaxis: Day 14/ET - total | 175 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Bleeding: screening - Toal | 178 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Nasal Irritation: Day 14/ET - None | 165 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Epistaxis: screening - None | 176 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Bleeding: screening - None | 167 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Nasal Irritation: Day 14/ET - Total | 175 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Crusting of Mucosa: screening - Moderate | 2 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Bleeding: screening - Mild | 2 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Nasal Irritation: screening - Grade 4 | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Epistaxis: screening - Severe | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Bleeding: screening - Moderate | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Nasal Irritation: screening - Grade 3 | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Epistaxis: screening - total | 178 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Bleeding: screening - Severe | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Nasal Irritation: screening - Grade 2 | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Crusting of Mucosa: screening - Severe | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Bleeding: Day 14/ET - Total | 175 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Nasal Irritation: screening - Grade 1B | 9 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Epistaxis: screening - Moderate | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Erythema: Day 14/ET - Severe | 1 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Bleeding: Day 14/ET - None | 163 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Nasal Discharge: screening - Mild | 67 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Nasal Irritation: screening - Grade 1A | 169 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Nasal Discharge: screening - None | 28 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Nasal Discharge: screening - Moderate | 71 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Crusting of Mucosa: Day 14/ET - Severe | 1 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Crusting of Mucosa: Day 14/ET - Mild | 16 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Nasal Discharge: screening - Severe | 12 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Nasal Discharge: screening - Total | 178 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Bleeding: Day 14/ET - Mild | 11 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Nasal Discharge: Day 14/ET - Total | 175 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Edema: Day 14/ET - Severe | 20 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Nasal Irritation: screening - None | 178 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Nasal Discharge: Day 14/ET - None | 47 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Edema: Day 14/ET - Moderate | 81 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Crusting of Mucosa: Day 14/ET - Total | 175 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Nasal Discharge: Day 14/ET- Mild | 72 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Edema: Day 14/ET - Mild | 59 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Bleeding: Day 14/ET - Moderate | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Nasal Discharge: Day 14/ET - Moderate | 45 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Edema: Day 14/ET - None | 15 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Nasal Irritation: screening - total | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Nasal Discharge: Day 14/ET - Severe | 11 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Edema: Day 14/ET - total | 175 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Epistaxis: Day 14/ET - Severe | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Erythema: screening - Total | 178 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Edema: screening - Severe | 33 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Bleeding: Day 14/ET - Severe | 1 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Erythema: screening - None | 92 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Edema: screening - Moderate | 114 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Epistaxis: Day 14/ET - Moderate | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Erythema: screening - Mild | 45 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Edema: screening - Mild | 28 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Epistaxis: screening - Mild | 2 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams | Mucosal Erythema: screening - Moderate | 39 Participants |
Secondary
Change From Baseline to Day 14 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Patients 18 Years of Age and Older
A 28-item RQLQ was completed on Day 1 and Day 14 or Early temination. The RQLQ consists of 7 domains rated on a 7 point scale with 0 being not troubled by the allergy symptoms, and 6 being extremely troubled/all of the time. Domain score will be calculated from the mean score of all items in the domain. Overall score will be calculated from the mean score of all items.
Time frame: baseline and 14 days
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Day 14 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Patients 18 Years of Age and Older | Baseline: Overall | 3.87 28 item/7 domain RQLQ on 0-6 scale | Standard Deviation 0.991 |
| Placebo | Change From Baseline to Day 14 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Patients 18 Years of Age and Older | Change from Baseline:Overall | -0.94 28 item/7 domain RQLQ on 0-6 scale | Standard Deviation 1.112 |
| Astepro 0.1% | Change From Baseline to Day 14 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Patients 18 Years of Age and Older | Baseline: Overall | 3.73 28 item/7 domain RQLQ on 0-6 scale | Standard Deviation 0.998 |
| Astepro 0.1% | Change From Baseline to Day 14 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Patients 18 Years of Age and Older | Change from Baseline:Overall | -1.12 28 item/7 domain RQLQ on 0-6 scale | Standard Deviation 1.246 |
| Astepro 0.15% | Change From Baseline to Day 14 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Patients 18 Years of Age and Older | Baseline: Overall | 3.75 28 item/7 domain RQLQ on 0-6 scale | Standard Deviation 1.012 |
| Astepro 0.15% | Change From Baseline to Day 14 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Patients 18 Years of Age and Older | Change from Baseline:Overall | -1.48 28 item/7 domain RQLQ on 0-6 scale | Standard Deviation 1.328 |