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
* Male and Female patients 12 years of age and older with a 2 year history of moderate to severe seasonal allergic rhinitis. * Must be in generally good health * Must meet minimum symptom requirements, as specified in the protocol * Must be willing and able to provide informed consent and to participate in all study procedures * Positive skin test to a prevalent Texas Mountain Cedar allergen
Exclusion criteria
* 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 subject from the study. * Other nasal disease(s) likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa, clinically significant polyposis, or nasal structural abnormalities. * Nasal surgery or sinus surgery within the previous year. * Chronic sinusitis - more than 3 episodes per year * Planned travel outside of the study area during the study period * The use of any investigational drug within 30 days prior to Screening. No investigational products are permitted for use during the conduct of this study * Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitol or sucralose (Splenda® brand sweetener) * Women who are pregnant or nursing * Women of childbearing potential who are not abstinent or not practicing a medically acceptable method of contraception * Respiratory Tract Infections within 14 days prior to screening * Respiratory Tract Infections requiring antibiotic treatment 14 days prior to screening * Asthma (with the exception of mild, 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 * Significant pulmonary disease including COPD * Clinically significant arrhythmia or symptomatic cardiac conditions * A known history of alcohol or drug abuse within the last 2 years * 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. * Clinically relevant abnormal physical findings which, in the opinion of the investigator, would interfere with the objectives of the study or that may preclude compliance with the study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (TNSS) (AM and PM Combined)at 14 Days | baseline and 14 days | reflective 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 Means Square 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 co-variate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (AM) for the Entire 14-day Study Period Compared to Placebo. | baseline and 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.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. |
| Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (AM and PM Combined) at 14 Days | 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 Means Square 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 co-variate |
| Change From Baseline in 12-hour Reflective Secondary Symptom Complex Score (SSCS) for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined) | baseline and 14-days | Reflective secondary complex 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 Means Square 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 co-variate |
| Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) | baseline and 14 Days | A 28-item RQLQ was completed on Day 1 and Day 14 or Early termination. 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 subscales 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 at 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 irritation 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 December 13, 2007 Last Observation February 21, 2008
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo Nasal Spray/2 sprays per nostril once daily for 14 days | 266 |
| Astepro 0.15% 0.15% Azelastine Hydrochloride Nasal Spray/2 sprays per nostril once daily for 14 days | 266 |
| Total | 532 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 4 |
| Overall Study | Lack of Efficacy | 2 | 3 |
| Overall Study | Lost to Follow-up | 3 | 2 |
| Overall Study | Non-Compliance | 0 | 4 |
| Overall Study | Other | 9 | 4 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Astepro 0.15% | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 20 Participants | 14 Participants | 34 Participants |
| Age, Categorical >=65 years | 16 Participants | 11 Participants | 27 Participants |
| Age, Categorical Between 18 and 65 years | 230 Participants | 241 Participants | 471 Participants |
| Age, Continuous | 40.9 years STANDARD_DEVIATION 14.51 | 39.5 years STANDARD_DEVIATION 14.41 | 40.2 years STANDARD_DEVIATION 14.46 |
| Region of Enrollment United States | 266 participants | 266 participants | 532 participants |
| Sex: Female, Male Female | 175 Participants | 171 Participants | 346 Participants |
| Sex: Female, Male Male | 91 Participants | 95 Participants | 186 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 266 | 29 / 266 |
| serious Total, serious adverse events | 0 / 266 | 0 / 266 |
Outcome results
Primary
Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (TNSS) (AM and PM Combined)at 14 Days
reflective 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 Means Square 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 co-variate
Time frame: baseline and 14 days
Population: ITT
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (TNSS) (AM and PM Combined)at 14 Days | Baseline symptom score | 17.98 Scores on a scale | Standard Deviation 3.334 |
| Placebo | Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (TNSS) (AM and PM Combined)at 14 Days | Overall change from baseline | -1.97 Scores on a scale | Standard Deviation 3.51 |
| Astepro 0.15% | Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (TNSS) (AM and PM Combined)at 14 Days | Baseline symptom score | 18.48 Scores on a scale | Standard Deviation 3.283 |
| Astepro 0.15% | Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (TNSS) (AM and PM Combined)at 14 Days | Overall change from baseline | -3.53 Scores on a scale | Standard Deviation 4.241 |
p-value: <0.00195% CI: [-2.22, -0.91]ANCOVA
Secondary
Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (AM and PM Combined) at 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 Means Square 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 co-variate
Time frame: baseline and 14-days
Population: ITT
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (AM and PM Combined) at 14 Days | Baseline symptom score | 16.30 Scores on a scale | Standard Deviation 4.054 |
| Placebo | Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (AM and PM Combined) at 14 Days | Overall change from baseline | -1.52 Scores on a scale | Standard Deviation 3.622 |
| Astepro 0.15% | Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (AM and PM Combined) at 14 Days | Baseline symptom score | 17.06 Scores on a scale | Standard Deviation 4.083 |
| Astepro 0.15% | Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (AM and PM Combined) at 14 Days | Overall change from baseline | -2.96 Scores on a scale | Standard Deviation 4.28 |
p-value: <0.00195% CI: [-2.11, -0.77]ANCOVA
Secondary
Change From Baseline in 12-hour Reflective Secondary Symptom Complex Score (SSCS) for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined)
Reflective secondary complex 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 Means Square 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 co-variate
Time frame: baseline and 14-days
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in 12-hour Reflective Secondary Symptom Complex Score (SSCS) for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined) | Baseline SSCS | 14.40 Scores on a scale | Standard Deviation 4.96 |
| Placebo | Change From Baseline in 12-hour Reflective Secondary Symptom Complex Score (SSCS) for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined) | Change in baseline to Day 14 | -1.52 Scores on a scale | Standard Deviation 3.388 |
| Astepro 0.15% | Change From Baseline in 12-hour Reflective Secondary Symptom Complex Score (SSCS) for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined) | Baseline SSCS | 14.83 Scores on a scale | Standard Deviation 4.709 |
| Astepro 0.15% | Change From Baseline in 12-hour Reflective Secondary Symptom Complex Score (SSCS) for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined) | Change in baseline to Day 14 | -2.81 Scores on a scale | Standard Deviation 4.206 |
Comparison: Change in baselinep-value: <0.00195% CI: [-1.92, 0.66]ANCOVA
Secondary
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
A 28-item RQLQ was completed on Day 1 and Day 14 or Early termination. 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 subscales 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: baseline and 14 Days
Population: ITT
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) | Baseline: Overall | 3.68 Units on a scale | Standard Deviation 1.077 |
| Placebo | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) | Change from Baseline:Overall | -0.76 Units on a scale | Standard Deviation 1.219 |
| Astepro 0.15% | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) | Baseline: Overall | 3.81 Units on a scale | Standard Deviation 1.059 |
| Astepro 0.15% | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) | Change from Baseline:Overall | -1.01 Units on a scale | Standard Deviation 1.304 |
Comparison: Change from baselinep-value: 0.001ANCOVA
Secondary
Change From Baseline on Direct Visual Nasal Exams at 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 irritation 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 at 14 Days | Nasal Discharge: screening -Moderate (n= 268, 268) | 79 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Nasal Irritation: screening - None ( n=268, 268) | 232 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Nasal Discharge: screening Severe(n= 268, 268) | 14 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Nasal Irritation: Day 14/ET Grade 1B (n=265, 266) | 2 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Nasal Discharge: Day 14/ET none (n=265, 266) | 79 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Epistaxis: screening - Mild ( n=268, 268) | 1 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Nasal Discharge: Day 14/ET Mild (n=265, 266) | 122 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Nasal Irritation: Day 14/ET Grade 2 (n=265, 266) | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Nasal Discharge: Day 14/ET Moderate (n=265, 266) | 64 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Nasal Irritation: screening -Grade 1A ( n=268, 268 | 36 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Nasal Discharge: Day 14/ET Severe (n=265, 266) | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Nasal Irritation: Day 14/ET Grade 3 (n=265, 266) | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Mucosal Erythema: screening none (n= 268, 268) | 145 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Epistaxis: Day 14/ET -Mild (n=265, 266) | 1 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Mucosal Erythema: screening Mild (n= 268, 268) | 71 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Nasal Irritation: Day 14/ET Grade 4 (n=265, 266) | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Mucosal Erythema: screening Moderate (n= 268, 268) | 50 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Nasal Irritation: screening Grade 1B ( n=268, 268) | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Mucosal Erythema: screening Severe (n= 268, 268) | 2 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Mucosal Edema: screening - none (n= 268, 268) | 18 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Mucosal Erythema: Day 14/ET none (n=265, 266) | 153 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Epistaxis: screening - Severe ( n=268, 268) | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Mucosal Erythema: Day 14/ET Mild (n=265, 266) | 66 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Mucosal Edema: screening - Mild (n= 268, 268) | 55 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Mucosal Erythema: Day 14/ET Moderate (n=265, 266) | 45 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Nasal Irritation: screening -Grade 2 ( n=268, 268) | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Mucosal Erythema: Day 14/ET Severe (n=265, 266) | 1 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Mucosal Edema: screening - Moderate (n= 268, 268) | 162 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Mucosal Bleeding: screening none (n= 268, 268) | 257 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Epistaxis: Day 14/ET -Moderate (n=265, 266) | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Mucosal Bleeding: screening Mild (n= 268, 268) | 11 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Mucosal Edema: screening - Severe (n= 268, 268) | 13 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Mucosal Bleeding: screening Moderate (n= 268, 268) | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Nasal Irritation: screening -Grade 3 ( n=268, 268) | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Mucosal Bleeding: screening Severe (n= 268, 268) | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Mucosal Edema: Day 14/ET none (n=265, 266) | 6 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Mucosal Bleeding: Day 14/ET none (n=265, 266) | 257 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Epistaxis: screening - Moderate ( n=268, 268) | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Mucosal Bleeding: Day 14/ET Mild (n=265, 266) | 8 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Mucosal Edema: Day 14/ET Mild (n=265, 266) | 88 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Mucosal Bleeding: Day 14/ET Moderate(n=265, 266) | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Nasal Irritation: screening -Grade 4 ( n=268, 268) | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Mucosal Bleeding: Day 14/ET Severe (n=265, 266) | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Mucosal Edema: Day 14/ET Moderate (n=265, 266) | 152 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Crusting of Mucosa: screening none (n= 268, 268) | 237 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Epistaxis: Day 14/ET -Severe (n=265, 266) | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Crusting of Mucosa: screening Mild (n= 268, 268) | 25 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Mucosal Edema: Day 14/ET Severe (n=265, 266) | 19 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Crusting of Mucosascreening Moderate (n= 268, 268) | 6 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Nasal Irritation: Day 14/ET - none (n=265, 266) | 248 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Crusting of Mucosa: screening Severe (n= 268, 268) | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Nasal Discharge: screening - none (n= 268, 268) | 63 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Crusting of Mucosa: Day 14/ET - none (n=265, 266) | 245 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Epistaxis: Day 14/ET -None (n=265, 266) | 264 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Crusting of Mucosa: Day 14/ET - Mild (n=265, 266) | 14 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Nasal Discharge: screening - Mild (n= 268, 268) | 112 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Crusting of Mucosa:Day 14/ET Moderate (n=265, 266) | 6 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Nasal Irritation: Day 14/ET Grade 1A (n=265, 266) | 15 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Crusting of Mucosa Day 14/ET Severe( n=265, 266) | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Epistaxis: screening - None ( n=268, 268) | 267 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Crusting of Mucosa Day 14/ET Severe( n=265, 266) | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Epistaxis: screening - None ( n=268, 268) | 267 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Epistaxis: screening - Mild ( n=268, 268) | 1 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Epistaxis: screening - Moderate ( n=268, 268) | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Epistaxis: screening - Severe ( n=268, 268) | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Epistaxis: Day 14/ET -None (n=265, 266) | 265 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Epistaxis: Day 14/ET -Mild (n=265, 266) | 1 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Epistaxis: Day 14/ET -Moderate (n=265, 266) | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Epistaxis: Day 14/ET -Severe (n=265, 266) | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Nasal Irritation: screening - None ( n=268, 268) | 230 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Nasal Irritation: screening -Grade 1A ( n=268, 268 | 38 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Nasal Irritation: screening Grade 1B ( n=268, 268) | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Nasal Irritation: screening -Grade 2 ( n=268, 268) | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Nasal Irritation: screening -Grade 3 ( n=268, 268) | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Nasal Irritation: screening -Grade 4 ( n=268, 268) | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Nasal Irritation: Day 14/ET - none (n=265, 266) | 251 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Nasal Irritation: Day 14/ET Grade 1A (n=265, 266) | 15 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Nasal Irritation: Day 14/ET Grade 1B (n=265, 266) | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Nasal Irritation: Day 14/ET Grade 2 (n=265, 266) | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Nasal Irritation: Day 14/ET Grade 3 (n=265, 266) | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Nasal Irritation: Day 14/ET Grade 4 (n=265, 266) | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Mucosal Edema: screening - none (n= 268, 268) | 14 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Mucosal Edema: screening - Mild (n= 268, 268) | 48 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Mucosal Edema: screening - Moderate (n= 268, 268) | 177 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Mucosal Edema: screening - Severe (n= 268, 268) | 29 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Mucosal Edema: Day 14/ET none (n=265, 266) | 17 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Mucosal Edema: Day 14/ET Mild (n=265, 266) | 77 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Mucosal Edema: Day 14/ET Moderate (n=265, 266) | 151 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Mucosal Edema: Day 14/ET Severe (n=265, 266) | 21 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Nasal Discharge: screening - none (n= 268, 268) | 58 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Nasal Discharge: screening - Mild (n= 268, 268) | 116 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Nasal Discharge: screening -Moderate (n= 268, 268) | 82 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Nasal Discharge: screening Severe(n= 268, 268) | 12 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Nasal Discharge: Day 14/ET none (n=265, 266) | 72 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Nasal Discharge: Day 14/ET Mild (n=265, 266) | 128 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Nasal Discharge: Day 14/ET Moderate (n=265, 266) | 62 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Nasal Discharge: Day 14/ET Severe (n=265, 266) | 4 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Mucosal Erythema: screening none (n= 268, 268) | 148 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Mucosal Erythema: screening Mild (n= 268, 268) | 69 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Mucosal Erythema: screening Moderate (n= 268, 268) | 48 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Mucosal Erythema: screening Severe (n= 268, 268) | 3 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Mucosal Erythema: Day 14/ET none (n=265, 266) | 157 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Mucosal Erythema: Day 14/ET Mild (n=265, 266) | 63 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Mucosal Erythema: Day 14/ET Moderate (n=265, 266) | 45 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Mucosal Erythema: Day 14/ET Severe (n=265, 266) | 1 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Mucosal Bleeding: screening none (n= 268, 268) | 259 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Mucosal Bleeding: screening Mild (n= 268, 268) | 8 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Mucosal Bleeding: screening Moderate (n= 268, 268) | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Mucosal Bleeding: screening Severe (n= 268, 268) | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Mucosal Bleeding: Day 14/ET none (n=265, 266) | 256 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Mucosal Bleeding: Day 14/ET Mild (n=265, 266) | 10 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Mucosal Bleeding: Day 14/ET Moderate(n=265, 266) | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Mucosal Bleeding: Day 14/ET Severe (n=265, 266) | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Crusting of Mucosa: screening none (n= 268, 268) | 245 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Crusting of Mucosa: screening Mild (n= 268, 268) | 15 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Crusting of Mucosascreening Moderate (n= 268, 268) | 7 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Crusting of Mucosa: screening Severe (n= 268, 268) | 1 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Crusting of Mucosa: Day 14/ET - none (n=265, 266) | 244 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Crusting of Mucosa: Day 14/ET - Mild (n=265, 266) | 16 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams at 14 Days | Crusting of Mucosa:Day 14/ET Moderate (n=265, 266) | 6 Participants |
Secondary
Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (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.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 | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (AM) for the Entire 14-day Study Period Compared to Placebo. | -0.66 Scores on a scale | Standard Error 1.859 |
| Astepro 0.15% | Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (AM) for the Entire 14-day Study Period Compared to Placebo. | -1.38 Scores on a scale | Standard Error 2.103 |
p-value: <0.00195% CI: [-1.07, -0.42]ANOVA