Seasonal Allergic Rhinitis
Conditions
Brief summary
The purpose of this study is to determine if one allergy medication (0.15% azelastine hydrochloride) is more effective than Placebo alone
Interventions
DRUGPlacebo
Placebo
0.15% azelastine hydrochloride 822 mcg
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 subjects 12 years of age and older 2. Provide written informed consent/pediatric assent. If the subject 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 visit 1 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 visit 2, and can include the morning of visit 2) 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 visit 2, and can include the morning of visit 2) 5. Willing and able to comply with the study requirements 6. At least a 2-year history of SAR during Texas Mountain Cedar season 7. The presence of IgE-mediated hypersensitivity to Texas Mountain Cedar, confirmed by a positive response to 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. 8. 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. 9. Subjects 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 do not preclude participation).Dose reduction when a new bottle is used does not preclude participation. 10. Subjects 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 superficial and moderate nasal mucosal erosion, nasal mucosal ulceration, or nasal septum perforation (Grade 1b-4) at either screening visit or randomization visit will disqualify the subjects from the study. 2. Other nasal disease(s) likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa, clinically significant polyposis, or clinically significant 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 visit 1. 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 visit 1 11. Respiratory Tract Infections requiring antibiotic treatment 14 days prior to visit 1 12. Asthma (with the exception of intermittent asthma). Subjects with mild, intermittent asthma who only require short-acting inhaled bronchodilators (not more often than twice per week) and who do not have nocturnal awakening as a result of asthma are eligible for enrollment 13. Significant pulmonary disease including COPD 14. Clinically significant arrhythmia or symptomatic cardiac conditions 15. A known history of alcohol or drug abuse within the last 2 years 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; that might significantly affect the subject's ability to complete this trial; or their safety in 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 MP439 or MP440. 19. Employees of the research center / private practice and their family are excluded
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 (AM and PM Combined)at 14 Days | 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 basline as a covariate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Instantaneous Total Nasal Symptom Sscore (AM) for the Entire 14-day Study Period Compared to Placebo | baseline to 14 Days | End of 24 hour dosing interval: This endpoint is change from baseline in instantaneous (tNSS) for the 14-day study period compared to placebo to observe if the duration of efficacy lasts 24 hours on a day to day basis. Instantaneous tNSS consists of runny nose, itchy nose, nasal congestion, and sneezing. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. 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. |
| Change From Baseline in Instantaneous Total Nasal Symptom Score for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined) | baseline to 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 12-hour Reflective Total Ocular Symptom Score and Instantaneous Total Ocular Symptom Score for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined) | baseline to14 Days | reflective and instantaneous symptom scores (itchy eyes, watery eyes and red eyes) 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 TOSS score is 9 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 Visit 4 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Subjects 18 Years of Age and Older | 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. Scores for a series of subsclaes are not combined for a total overall score, rather 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 to 14 Days | baseline and 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: 30 Dec 2008 Last observation: 13 Feb 2009
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/2 sprays per nostril once a day for 14 days | 254 |
| Astepro 0.15% 0.15% azelastine hydrochloride Nasal Spray/2 sprays per nostril once a day for 14 days | 251 |
| Total | 505 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 5 |
| Overall Study | Lack of Efficacy | 2 | 2 |
| Overall Study | Non-Compliance | 4 | 2 |
| Overall Study | Other | 1 | 1 |
| Overall Study | Protocol Violation | 2 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 3 |
Baseline characteristics
| Characteristic | Placebo | Astepro 0.15% | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 27 Participants | 24 Participants | 51 Participants |
| Age, Categorical >=65 years | 7 Participants | 9 Participants | 16 Participants |
| Age, Categorical Between 18 and 65 years | 220 Participants | 218 Participants | 438 Participants |
| Age Continuous | 38.5 years STANDARD_DEVIATION 14.59 | 38.0 years STANDARD_DEVIATION 14.4 | 38.2 years STANDARD_DEVIATION 14.48 |
| Region of Enrollment United States | 254 participants | 251 participants | 505 participants |
| Sex: Female, Male Female | 150 Participants | 157 Participants | 307 Participants |
| Sex: Female, Male Male | 104 Participants | 94 Participants | 198 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 255 | 25 / 251 |
| serious Total, serious adverse events | 0 / 255 | 0 / 251 |
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 (AM and PM Combined)at 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 basline 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 (AM and PM Combined)at 14 Days | Baseline symptom score | 18.76 Scores on a scale | Standard Deviation 3.301 |
| Placebo | Change From Baseline in 12-hour Reflective Total Nasal Symptom Score(rTNSS)for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined)at 14 Days | Overall change from baseline | -2.14 Scores on a scale | Standard Deviation 3.696 |
| 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 (AM and PM Combined)at 14 Days | Baseline symptom score | 18.48 Scores on a scale | Standard Deviation 3.231 |
| 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 (AM and PM Combined)at 14 Days | Overall change from baseline | -3.57 Scores on a scale | Standard Deviation 4.242 |
Comparison: Overall change from baselinep-value: <0.00195% CI: [-2.12, -0.74]ANCOVA
Secondary
Change From Baseline in 12-hour Reflective Total Ocular Symptom Score and Instantaneous Total Ocular Symptom Score for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined)
reflective and instantaneous symptom scores (itchy eyes, watery eyes and red eyes) 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 TOSS score is 9 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 to14 Days
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in 12-hour Reflective Total Ocular Symptom Score and Instantaneous Total Ocular Symptom Score for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined) | Baseline: Instantaneous | 11.33 Scores on a scale | Standard Deviation 4.7 |
| Placebo | Change From Baseline in 12-hour Reflective Total Ocular Symptom Score and Instantaneous Total Ocular Symptom Score for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined) | Baseline: Reflective | 11.85 Scores on a scale | Standard Deviation 4.58 |
| Placebo | Change From Baseline in 12-hour Reflective Total Ocular Symptom Score and Instantaneous Total Ocular Symptom Score for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined) | Change from Baseline: Instantaneous | -1.05 Scores on a scale | Standard Deviation 2.913 |
| Placebo | Change From Baseline in 12-hour Reflective Total Ocular Symptom Score and Instantaneous Total Ocular Symptom Score for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined) | Change from Baseline: Reflective | -1.28 Scores on a scale | Standard Deviation 2.932 |
| Astepro 0.15% | Change From Baseline in 12-hour Reflective Total Ocular Symptom Score and Instantaneous Total Ocular Symptom Score for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined) | Change from Baseline: Instantaneous | -2.03 Scores on a scale | Standard Deviation 3.313 |
| Astepro 0.15% | Change From Baseline in 12-hour Reflective Total Ocular Symptom Score and Instantaneous Total Ocular Symptom Score for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined) | Baseline: Reflective | 11.52 Scores on a scale | Standard Deviation 4.273 |
| Astepro 0.15% | Change From Baseline in 12-hour Reflective Total Ocular Symptom Score and Instantaneous Total Ocular Symptom Score for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined) | Baseline: Instantaneous | 11.08 Scores on a scale | Standard Deviation 4.449 |
| Astepro 0.15% | Change From Baseline in 12-hour Reflective Total Ocular Symptom Score and Instantaneous Total Ocular Symptom Score for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined) | Change from Baseline: Reflective | -2.21 Scores on a scale | Standard Deviation 3.419 |
Comparison: reflective TOSS change in baselinep-value: <0.00195% CI: [-1.47, -0.39]ANCOVA
Secondary
Change From Baseline in Instantaneous Total Nasal Symptom Score for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined)
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 to 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 (AM and PM Combined) | Baseline symptom score | 17.63 scores on a scale | Standard Deviation 3.906 |
| Placebo | Change From Baseline in Instantaneous Total Nasal Symptom Score for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined) | Overall change from baseline | -1.73 scores on a scale | Standard Deviation 3.669 |
| Astepro 0.15% | Change From Baseline in Instantaneous Total Nasal Symptom Score for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined) | Baseline symptom score | 17.43 scores on a scale | Standard Deviation 3.665 |
| Astepro 0.15% | Change From Baseline in Instantaneous Total Nasal Symptom Score for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined) | Overall change from baseline | -3.12 scores on a scale | Standard Deviation 4.099 |
Comparison: Overall change from baselinep-value: <0.00195% CI: [-2.06, -0.73]ANCOVA
Secondary
Change From Baseline on Direct Visual Nasal Exams to 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
Time frame: baseline and 14 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Nasal Irritation: Day 14/ET- Grade 4 (n=255, 249) | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Epistaxis: screening - None (n=255, 251) | 255 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Epistaxis: screening - Mild (n=255, 251) | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Epistaxis: screening - Moderate (n=255, 251) | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Epistaxis: screening - Severe (n=255, 251) | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Epistaxis: Day 14/ET - None (n=255, 249) | 254 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Epistaxis: Day 14/ET - Mild (n=255, 249) | 1 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Epistaxis: Day 14/ET - Moderate (n=255, 249) | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Epistaxis: Day 14/ET - Severe (n=255, 249) | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Nasal Irritation: screening - None (n=255, 251) | 236 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Nasal Irritation: screening -Grade 1A (n=255, 251 | 19 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Nasal Irritation: screening -Grade 1B (n=255, 251) | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Nasal Irritation: screening - Grade 2 (n=255, 251) | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Nasal Irritation: screening - Grade 3 (n=255, 251) | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Nasal Irritation: screening - Grade 4 (n=255, 251) | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Nasal Irritation: Day 14/ET - None(n=255, 249) | 246 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Nasal Irritation: Day 14/ET- Grade 1A (n=255, 249) | 8 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Nasal Irritation: Day 14/ET- Grade 1B (n=255, 249) | 1 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Nasal Irritation: Day 14/ET- Grade 2 (n=255, 249) | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Nasal Irritation: Day 14/ET- Grade 3 (n=255, 249) | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Mucosal Edema: screening - None (n=255, 251) | 18 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Mucosal Edema: screening - Mild (n=255, 251) | 54 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Mucosal Edema: screening - Moderate (n=255, 251) | 155 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Mucosal Edema: screening - Severe (n=255, 251) | 28 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Mucosal Edema: Day 14/ET - None (n=255, 249) | 18 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Mucosal Edema: Day 14/ET - Mild (n=255, 249) | 73 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Mucosal Edema: Day 14/ET - Moderate (n=255, 249) | 131 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Mucosal Edema: Day 14/ET - Severe (n=255, 249) | 33 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Nasal Discharge: screening - None (n=255, 251) | 41 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Nasal Discharge: screening - Mild (n=255, 251) | 102 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Nasal Discharge: screening - Moderate (n=255, 251) | 97 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Nasal Discharge: screening - Severe (n=255, 251) | 15 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Nasal Discharge: Day 14/ET - None (n=255, 249) | 38 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Mucosal Erythema: screening -Moderate (n=255, 251) | 47 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Mucosal Erythema: screening -Severe (n=255, 251) | 6 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Mucosal Erythema: Day 14/ET - None (n=255, 249) | 153 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Mucosal Erythema: Day 14/ET - Mild (n=255, 249) | 49 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Mucosal Erythema: Day 14/ET Moderate (n=255, 249) | 43 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Mucosal Erythema: Day 14/ET Severe (n=255, 249) | 10 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Mucosal Bleeding: screening - None (n=255, 251) | 251 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Mucosal Bleeding: screening - Mild (n=255, 251) | 4 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Mucosal Bleeding: screening Moderate (n=255, 251) | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Mucosal Bleeding: screening - Severe (n=255, 251) | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Mucosal Bleeding: Day 14/ET - None (n=255, 249) | 254 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Mucosal Bleeding: Day 14/ET - Mild (n=255, 249) | 1 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Mucosal Bleeding: Day 14/ET Moderate (n=255, 249) | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Mucosal Bleeding: Day 14/ET - Severe (n=255, 249) | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Crusting of Mucosa: screening - None (n=255, 251) | 236 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Crusting of Mucosa: screening - Mild (n=255, 251) | 17 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Crusting of Mucosascreening Moderate (n=255,251) | 2 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Nasal Discharge: Day 14/ET- Mild (n=255, 249) | 130 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Nasal Discharge: Day 14/ET - Moderate (n=255, 249) | 80 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Nasal Discharge: Day 14/ET - Severe (n=255, 249) | 7 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Mucosal Erythema: screening - None (n=255, 251) | 153 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Mucosal Erythema: screening -Mild (n=255, 251) | 49 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Crusting of Mucosa: screening Severe (n=255, 251) | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Crusting of Mucosa: Day 14/ET - None (n=255, 249) | 248 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Crusting of Mucosa: Day 14/ET - Mild (n=255, 249) | 5 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Crusting of Mucosa:Day 14/ET Moderate (n=255, 249) | 1 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Crusting of Mucosa:Day 14/ET Severe (n=255, 249) | 1 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Mucosal Bleeding: Day 14/ET - Mild (n=255, 249) | 6 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Nasal Irritation: Day 14/ET- Grade 4 (n=255, 249) | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Nasal Discharge: screening - Moderate (n=255, 251) | 89 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Epistaxis: screening - None (n=255, 251) | 249 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Crusting of Mucosa:Day 14/ET Severe (n=255, 249) | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Epistaxis: screening - Mild (n=255, 251) | 2 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Nasal Discharge: screening - Severe (n=255, 251) | 21 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Epistaxis: screening - Moderate (n=255, 251) | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Mucosal Erythema: screening -Mild (n=255, 251) | 60 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Epistaxis: screening - Severe (n=255, 251) | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Mucosal Bleeding: Day 14/ET Moderate (n=255, 249) | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Epistaxis: Day 14/ET - None (n=255, 249) | 246 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Nasal Discharge: Day 14/ET - None (n=255, 249) | 45 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Epistaxis: Day 14/ET - Mild (n=255, 249) | 3 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Nasal Discharge: Day 14/ET - Severe (n=255, 249) | 17 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Epistaxis: Day 14/ET - Moderate (n=255, 249) | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Mucosal Erythema: screening -Moderate (n=255, 251) | 49 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Epistaxis: Day 14/ET - Severe (n=255, 249) | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Mucosal Bleeding: Day 14/ET - Severe (n=255, 249) | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Nasal Irritation: screening - None (n=255, 251) | 231 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Mucosal Erythema: screening -Severe (n=255, 251) | 3 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Nasal Irritation: screening -Grade 1A (n=255, 251 | 20 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Crusting of Mucosa: Day 14/ET - None (n=255, 249) | 240 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Nasal Irritation: screening -Grade 1B (n=255, 251) | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Mucosal Erythema: Day 14/ET - None (n=255, 249) | 145 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Nasal Irritation: screening - Grade 2 (n=255, 251) | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Crusting of Mucosa: screening - None (n=255, 251) | 229 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Nasal Irritation: screening - Grade 3 (n=255, 251) | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Mucosal Erythema: Day 14/ET - Mild (n=255, 249) | 50 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Nasal Irritation: screening - Grade 4 (n=255, 251) | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Mucosal Erythema: screening - None (n=255, 251) | 139 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Nasal Irritation: Day 14/ET - None(n=255, 249) | 228 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Mucosal Erythema: Day 14/ET Moderate (n=255, 249) | 36 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Nasal Irritation: Day 14/ET- Grade 1A (n=255, 249) | 19 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Crusting of Mucosa: screening - Mild (n=255, 251) | 19 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Nasal Irritation: Day 14/ET- Grade 1B (n=255, 249) | 2 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Mucosal Erythema: Day 14/ET Severe (n=255, 249) | 18 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Nasal Irritation: Day 14/ET- Grade 2 (n=255, 249) | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Crusting of Mucosa:Day 14/ET Moderate (n=255, 249) | 1 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Nasal Irritation: Day 14/ET- Grade 3 (n=255, 249) | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Mucosal Bleeding: screening - None (n=255, 251) | 247 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Mucosal Edema: screening - None (n=255, 251) | 19 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Crusting of Mucosascreening Moderate (n=255,251) | 3 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Mucosal Edema: screening - Mild (n=255, 251) | 58 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Mucosal Bleeding: screening - Mild (n=255, 251) | 3 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Mucosal Edema: screening - Moderate (n=255, 251) | 129 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Crusting of Mucosa: Day 14/ET - Mild (n=255, 249) | 8 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Mucosal Edema: screening - Severe (n=255, 251) | 45 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Mucosal Bleeding: screening Moderate (n=255, 251) | 1 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Mucosal Edema: Day 14/ET - None (n=255, 249) | 24 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Nasal Discharge: Day 14/ET- Mild (n=255, 249) | 120 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Mucosal Edema: Day 14/ET - Mild (n=255, 249) | 66 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Mucosal Bleeding: screening - Severe (n=255, 251) | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Mucosal Edema: Day 14/ET - Moderate (n=255, 249) | 123 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Crusting of Mucosa: screening Severe (n=255, 251) | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Mucosal Edema: Day 14/ET - Severe (n=255, 249) | 36 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Mucosal Bleeding: Day 14/ET - None (n=255, 249) | 243 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Nasal Discharge: screening - None (n=255, 251) | 33 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Nasal Discharge: Day 14/ET - Moderate (n=255, 249) | 67 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 14 Days | Nasal Discharge: screening - Mild (n=255, 251) | 108 Participants |
Secondary
Change From Baseline to Visit 4 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Subjects 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. Scores for a series of subsclaes are not combined for a total overall score, rather 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: 14 Days
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Visit 4 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Subjects 18 Years of Age and Older | Baseline: | 4.39 Units on a Scale | Standard Deviation 1.149 |
| Placebo | Change From Baseline to Visit 4 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Subjects 18 Years of Age and Older | Change from Baseline: | -0.98 Units on a Scale | Standard Deviation 1.463 |
| Astepro 0.15% | Change From Baseline to Visit 4 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Subjects 18 Years of Age and Older | Baseline: | 4.33 Units on a Scale | Standard Deviation 1.226 |
| Astepro 0.15% | Change From Baseline to Visit 4 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Subjects 18 Years of Age and Older | Change from Baseline: | -1.33 Units on a Scale | Standard Deviation 1.599 |
Comparison: change from baselinep-value: 0.01ANCOVA
Secondary
Mean Change From Baseline in Instantaneous Total Nasal Symptom Sscore (AM) for the Entire 14-day Study Period Compared to Placebo
End of 24 hour dosing interval: This endpoint is change from baseline in instantaneous (tNSS) for the 14-day study period compared to placebo to observe if the duration of efficacy lasts 24 hours on a day to day basis. Instantaneous tNSS consists of runny nose, itchy nose, nasal congestion, and sneezing. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. 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 to 14 Days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Instantaneous Total Nasal Symptom Sscore (AM) for the Entire 14-day Study Period Compared to Placebo | -0.83 Score on a scale | Standard Deviation 1.842 |
| Astepro 0.15% | Mean Change From Baseline in Instantaneous Total Nasal Symptom Sscore (AM) for the Entire 14-day Study Period Compared to Placebo | -1.43 Score on a scale | Standard Deviation 2.088 |
p-value: <0.00195% CI: [-0.94, -0.27]ANCOVA