Perennial Allergic Rhinitis
Conditions
Brief summary
The purpose of this study is to determine if two allergy medications are more effective than placebo.
Interventions
0.15% azelastine hydrochloride 1644 mcg
DRUG0.1% azelastine hydrochloride
0.1% azelastine hydrochloride 1096 mcg
DRUGPlacebo
Placebo
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 * Must be in generally good health * Must meet minimum symptom requirements, as specified in protocol * Must be willing and able to provide informed consent and participate in all study procedures * 2-year history of PAR * Positive skin test to cockroach, dust mite, mold or cat/dog dander
Exclusion criteria
* On nasal examination, presence of any nasal mucosal erosion, nasal ulceration or nasal septal perforation at the screening or randomization visit * Nasal diseases likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa, significant polyposis or nasal structural abnormalities * Nasal surgery or sinus surgery within the previous year * The use of any investigational drug within 30 days * Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitol or sucralose * Women who are pregnant or nursing * Women of child-bearing potential who are not abstinent and not practicing a medically acceptable method of contraception * Respiratory tract infection within 2 weeks of screening * Respiratory tract infections requiring oral antibiotic treatment within 2 weeks of screening * Patients with asthma with the exception of mild, intermittent * Significant pulmonary disease including COPD * Patients with arrhythmia * Patients with a known history of alcohol or drug abuse * Existence of any surgical or medical condition, which in the opinion of the investigator or sponsor may significantly alter the absorption, distribution, metabolism or excretion of study drug. * Clinically relevant abnormal physical findings within one week of randomization * Overnight abscences from home for more than 3 nights * Employees of the research center or private practice and family members are excluded * Patients who received prohibited medications within specified timepoints in protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined) at 28 Days. | baseline and 28 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 square means (LS Mean) 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 |
|---|---|---|
| Change From Baseline in Instantaneous Total Nasal Symprom scoreS Compared to Placebo (AM and PM Combined)and 28 Days | baseline and 28 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. |
| Change From Baseline in 12-hour Reflective Secondary Symptom Complex Score Compared to Placebo (AM and PM Combined)and 28 Days | baseline and 28 days | Reflective secondary symptom complex scores (SSCS) (post-nasal drip, itchy eyes, cough and headacdhe) 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. |
| Change From Baseline in Rinoconjunctivitis Quality of Life Questionnaire and 28 Days | baseline and 28 Days | A 28-item RQLQ was completed on Day 1 and Day 28 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 and 28 Days | baseline and 28 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: February 5, 2007 Last Observation: October 8, 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/2 sprays per nostril 2 times a day for 4 weeks | 192 |
| Astepro 0.1% 0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks | 194 |
| Astepro 0.15% 0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks | 192 |
| Total | 578 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 3 | 4 | 7 |
| Overall Study | Lack of Efficacy | 1 | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 4 | 0 |
| Overall Study | Non-compliance | 3 | 0 | 0 |
| Overall Study | Other | 5 | 7 | 3 |
| Overall Study | Withdrawal by Subject | 4 | 2 | 1 |
Baseline characteristics
| Characteristic | Astepro 0.1% | Astepro 0.15% | Placebo | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 11 Participants | 18 Participants | 21 Participants | 50 Participants |
| Age, Categorical >=65 years | 0 Participants | 4 Participants | 10 Participants | 14 Participants |
| Age, Categorical Between 18 and 65 years | 183 Participants | 170 Participants | 161 Participants | 514 Participants |
| Age Continuous | 36.9 years STANDARD_DEVIATION 13.09 | 35.6 years STANDARD_DEVIATION 13.31 | 38.1 years STANDARD_DEVIATION 15.37 | 36.9 years STANDARD_DEVIATION 13.97 |
| Region of Enrollment United States | 194 participants | 192 participants | 192 participants | 578 participants |
| Sex: Female, Male Female | 136 Participants | 127 Participants | 130 Participants | 393 Participants |
| Sex: Female, Male Male | 58 Participants | 65 Participants | 62 Participants | 185 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 | 21 / 192 | 27 / 194 | 32 / 192 |
| serious Total, serious adverse events | 0 / 192 | 0 / 194 | 0 / 192 |
Outcome results
Primary
Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined) at 28 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 square means (LS Mean) 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 28 days
Population: ITT
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined) at 28 Days. | Baseline Least Squares Mean Symptom Score | 14.7 Scores on a Scale | 0 |
| Placebo | Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined) at 28 Days. | Change from baseline LS Mean symptom score | -3.1 Scores on a Scale | 0 |
| Astepro 0.1% | Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined) at 28 Days. | Baseline Least Squares Mean Symptom Score | 15.5 Scores on a Scale | 0 |
| Astepro 0.1% | Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined) at 28 Days. | Change from baseline LS Mean symptom score | -3.8 Scores on a Scale | 0 |
| Astepro 0.15% | Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined) at 28 Days. | Baseline Least Squares Mean Symptom Score | 15.8 Scores on a Scale | 0 |
| Astepro 0.15% | Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined) at 28 Days. | Change from baseline LS Mean symptom score | -4.0 Scores on a Scale | 0 |
p-value: 0.0395% CI: [-1.7, -0.1]ANCOVA
p-value: 0.0895% CI: [-1.5, 0.1]ANCOVA
Secondary
Change From Baseline in 12-hour Reflective Secondary Symptom Complex Score Compared to Placebo (AM and PM Combined)and 28 Days
Reflective secondary symptom complex scores (SSCS) (post-nasal drip, itchy eyes, cough and headacdhe) 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.
Time frame: baseline and 28 days
Population: ITT
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in 12-hour Reflective Secondary Symptom Complex Score Compared to Placebo (AM and PM Combined)and 28 Days | Baseline SSCS | 11.20 Scores on a Scale | Standard Deviation 4.936 |
| Placebo | Change From Baseline in 12-hour Reflective Secondary Symptom Complex Score Compared to Placebo (AM and PM Combined)and 28 Days | Change in baseline to Day 28 | -1.79 Scores on a Scale | Standard Deviation 3.42 |
| Astepro 0.1% | Change From Baseline in 12-hour Reflective Secondary Symptom Complex Score Compared to Placebo (AM and PM Combined)and 28 Days | Change in baseline to Day 28 | -2.23 Scores on a Scale | Standard Deviation 3.865 |
| Astepro 0.1% | Change From Baseline in 12-hour Reflective Secondary Symptom Complex Score Compared to Placebo (AM and PM Combined)and 28 Days | Baseline SSCS | 11.77 Scores on a Scale | Standard Deviation 5.036 |
| Astepro 0.15% | Change From Baseline in 12-hour Reflective Secondary Symptom Complex Score Compared to Placebo (AM and PM Combined)and 28 Days | Baseline SSCS | 12.39 Scores on a Scale | Standard Deviation 4.885 |
| Astepro 0.15% | Change From Baseline in 12-hour Reflective Secondary Symptom Complex Score Compared to Placebo (AM and PM Combined)and 28 Days | Change in baseline to Day 28 | -2.92 Scores on a Scale | Standard Deviation 4.053 |
Comparison: Change in baseline to Day 28p-value: 0.22695% CI: [-1.15, 0.27]ANCOVA
Comparison: Change in baseline to Day 28p-value: 0.00295% CI: [-1.84, -0.41]ANCOVA
Secondary
Change From Baseline in Instantaneous Total Nasal Symprom scoreS Compared to Placebo (AM and PM Combined)and 28 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.
Time frame: baseline and 28 days
Population: ITT
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Instantaneous Total Nasal Symprom scoreS Compared to Placebo (AM and PM Combined)and 28 Days | Baseline Symptom score | 13.28 Scores on a Scale | Standard Deviation 4.614 |
| Placebo | Change From Baseline in Instantaneous Total Nasal Symprom scoreS Compared to Placebo (AM and PM Combined)and 28 Days | Overall Change from baseline | -2.72 Scores on a Scale | Standard Deviation 4.129 |
| Astepro 0.1% | Change From Baseline in Instantaneous Total Nasal Symprom scoreS Compared to Placebo (AM and PM Combined)and 28 Days | Baseline Symptom score | 13.91 Scores on a Scale | Standard Deviation 4.616 |
| Astepro 0.1% | Change From Baseline in Instantaneous Total Nasal Symprom scoreS Compared to Placebo (AM and PM Combined)and 28 Days | Overall Change from baseline | -3.36 Scores on a Scale | Standard Deviation 3.898 |
| Astepro 0.15% | Change From Baseline in Instantaneous Total Nasal Symprom scoreS Compared to Placebo (AM and PM Combined)and 28 Days | Baseline Symptom score | 14.30 Scores on a Scale | Standard Deviation 4.572 |
| Astepro 0.15% | Change From Baseline in Instantaneous Total Nasal Symprom scoreS Compared to Placebo (AM and PM Combined)and 28 Days | Overall Change from baseline | -3.51 Scores on a Scale | Standard Deviation 4.166 |
p-value: 0.10295% CI: [-1.41, 0.13]ANCOVA
p-value: 0.04495% CI: [-1.56, -0.02]ANCOVA
Secondary
Change From Baseline in Rinoconjunctivitis Quality of Life Questionnaire and 28 Days
A 28-item RQLQ was completed on Day 1 and Day 28 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 28 Days
Population: ITT
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Rinoconjunctivitis Quality of Life Questionnaire and 28 Days | Baseline: Overall | 2.98 Units on a Scale | Standard Deviation 1.047 |
| Placebo | Change From Baseline in Rinoconjunctivitis Quality of Life Questionnaire and 28 Days | Change from Baseline:Overall | -0.81 Units on a Scale | Standard Deviation 1.112 |
| Astepro 0.1% | Change From Baseline in Rinoconjunctivitis Quality of Life Questionnaire and 28 Days | Baseline: Overall | 3.18 Units on a Scale | Standard Deviation 1.048 |
| Astepro 0.1% | Change From Baseline in Rinoconjunctivitis Quality of Life Questionnaire and 28 Days | Change from Baseline:Overall | -1.05 Units on a Scale | Standard Deviation 1.088 |
| Astepro 0.15% | Change From Baseline in Rinoconjunctivitis Quality of Life Questionnaire and 28 Days | Baseline: Overall | 3.29 Units on a Scale | Standard Deviation 1.091 |
| Astepro 0.15% | Change From Baseline in Rinoconjunctivitis Quality of Life Questionnaire and 28 Days | Change from Baseline:Overall | -0.94 Units on a Scale | Standard Deviation 1.096 |
p-value: 0.292ANCOVA
p-value: 0.04ANCOVA
Secondary
Change From Baseline on Direct Visual Nasal Exams and 28 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 28 days
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Discharge: screening - None (n=192,197,192) | 55 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Lymphadenopathy: Day 28/ET Severe ( n=190,192,192) | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Crusting of Mucosa:Day 28/ET None (n=190,192,192) | 176 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Discharge: screening - Mild (n=192,197,192) | 79 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Erythmatous TM: Day 28/ET Moderate (n=190,192,192) | 2 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Crusting of Mucosa screening Severe(n=192,197,192) | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Discharge:screening Moderate (n=192,197,192) | 48 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Irritation screening Grade1B (n=192,197,192) | 3 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | CrustingofMucosa screening Moderate(n=192,197,192) | 4 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Discharge: screening Severe (n=192,197,192) | 10 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Lymphadenopathy: Day 28/ET None (n=190,192, 192) | 184 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Crusting of Mucosa: screening Mild (n=192,197,192) | 15 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Discharge:Day 28/ET None (n=190,192,192) | 77 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Erythmatous TM: Day 28/ET Mild (n=190,192, 192) | 8 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Crusting of Mucosa: screening None (n=192,197,192) | 173 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Discharge:Day 28/ET Mild (n=190,192,192) | 75 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Irritationscreening Grade 2 (n=192,197,192) | 1 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Bleeding: Day 28/ET Severe (n=190,192,192) | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Discharge:Day 28/ET Moderate (n=190,192,192) | 31 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Epistaxis: screening - Severe (n=192,197,192) | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Bleeding Day 28/ETModerate (n=190,192,192) | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Discharge:Day 28/ET Severe (n=190,192,192) | 7 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Erythmatous TM: Day 28/ET None (n=190,192, 192) | 179 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Bleeding: Day 28/ET Mild (n=190,192,192) | 1 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Erythema screening None (n=192,197,192) | 91 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Irritation screening Grade 3 (n=192,197,192) | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Bleeding: Day 28/ET None (n=190,192,192) | 189 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Erythema screening Mild (n=192,197,192) | 61 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Lymphadenopathy Day 28/ET Moderate (n=190,192,192) | 1 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Bleeding screening Severe (n=192,197,192) | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Erythema screeningModerate (n=192,197,192) | 37 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Erythmatous TM:screening Severe (n=192,197,192) | 1 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Bleedingscreening Moderate (n=192,197,192) | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Erythema screening Severe (n=192,197,192) | 3 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Irritation screening Grade 4 (n=192,197,192) | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Bleeding: screening Mild (n=192,197,192) | 7 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Erythema Day 28/ET None (n=190,192,192) | 101 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Lymphadenopathy:screening Severe (n=192,197,192) | 1 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Bleeding: screening None (n=192,197,192) | 185 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Erythema Day 28/ET Mild (n=190,192,192) | 64 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Erythmatous TM: screening Moderate(n=192,197,192) | 2 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Erythema Day 28/ET Severe (n=190,192,192) | 2 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Erythema Day 28/ET Moderate (n=190,192,192 | 23 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Irritation Day 28/ET None (n=190,192,192) | 182 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Epistaxis: Day 28/ET - None (n=190,192,192) | 188 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Erythmatous TM: screening Mild (n=192,197,192) | 9 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Irritation Day 28/ETGrade 1A (n=190,192,192) | 7 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Epistaxis: Day 28/ET - Mild (n=190,192,192) | 2 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Erythmatous TM: screening None (n=192,197,192) | 180 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Irritation Day 28/ETGrade 1B (n=190,192,192) | 1 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Epistaxis: screening - Mild (n=192,197,192) | 3 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Conjuntival Day 28/ET Severe (n=190,192, 192) | 2 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Irritation Day 28/ETGrade 2 (n=190,192,192) | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Lymphadenopathy:screening Moderate (n=192,197,192) | 1 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Conjuntival Day 28/ET Moderate(n=190,192) | 6 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Irritation Day 28/ETGrade 3 (n=190,192,192) | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Epistaxis: Day 28/ET - Moderate (n=190,192,192) | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Conjuntival Day 28/ET Mild(n=190,192,192) | 57 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Irritation Day 28/ETGrade 4 (n=190,192,192) | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Epistaxis: screening - None (n=192,197,192) | 189 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Conjuntival Day 28/ET None(n=190,192,192) | 125 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Edema: screening - None (n=192,197,192) | 25 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Lymphadenopathy: screening Mild (n=192,197,192) | 4 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Conjuntival screeningSevere(n=192,197,192) | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Edema: screening - Mild (n=192,197,192) | 50 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Epistaxis: Day 28/ET - Severe (n=190,192,192) | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Conjuntival screening Moderate n=(192,192, 192) | 10 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Edema: screening Moderate (n=192,197,192) | 98 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Lymphadenopathy: Day 28/ET Mild (n=190,192, 192) | 5 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Edema: screening - Severe (n=192,197,192) | 19 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Lymphadenopathy: screening None (n=192,197,192) | 186 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Conjuntival screening Mild (n=192,197,192) | 56 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Edema: Day 28/ET None (n=190,192,192) | 38 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Irritation: screening - None (n=192,197,192) | 180 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Conjuntival screening None (n=192,197,192) | 126 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Edema: Day 28/ET Mild (n=190,192,192) | 69 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Epistaxis: screening - Moderate (n=192,197,192) | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Crusting of Mucosa:Day 28/ET Severe(n=190,192,192) | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Edema: Day 28/ET Moderate (n=190,192,192) | 70 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Erythmatous TM: Day 28/ET Severe (n=190,192, 192) | 1 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | CrustingofMucosaDay 28/ET Moderate (n=190,192,192) | 0 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Edema: Day 28/ET Severe (n=190,192,192) | 13 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Irritationscreening Grade 1A (n=192,197,192) | 8 Participants |
| Placebo | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Crusting of Mucosa:Day 28/ET Mild (n=190,192,192) | 14 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Crusting of Mucosa: screening None (n=192,197,192) | 178 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Epistaxis: Day 28/ET - None (n=190,192,192) | 189 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Epistaxis: screening - None (n=192,197,192) | 194 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Epistaxis: screening - Mild (n=192,197,192) | 3 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Epistaxis: screening - Moderate (n=192,197,192) | 0 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Epistaxis: screening - Severe (n=192,197,192) | 0 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Epistaxis: Day 28/ET - Mild (n=190,192,192) | 3 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Epistaxis: Day 28/ET - Moderate (n=190,192,192) | 0 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Epistaxis: Day 28/ET - Severe (n=190,192,192) | 0 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Irritation: screening - None (n=192,197,192) | 183 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Irritationscreening Grade 1A (n=192,197,192) | 12 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Irritation screening Grade1B (n=192,197,192) | 2 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Irritationscreening Grade 2 (n=192,197,192) | 0 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Irritation screening Grade 3 (n=192,197,192) | 0 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Irritation screening Grade 4 (n=192,197,192) | 0 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Irritation Day 28/ET None (n=190,192,192) | 178 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Irritation Day 28/ETGrade 1A (n=190,192,192) | 12 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Irritation Day 28/ETGrade 1B (n=190,192,192) | 1 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Irritation Day 28/ETGrade 2 (n=190,192,192) | 0 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Irritation Day 28/ETGrade 3 (n=190,192,192) | 0 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Irritation Day 28/ETGrade 4 (n=190,192,192) | 1 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Edema: screening - None (n=192,197,192) | 30 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Edema: screening - Mild (n=192,197,192) | 54 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Edema: screening Moderate (n=192,197,192) | 84 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Edema: screening - Severe (n=192,197,192) | 29 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Edema: Day 28/ET None (n=190,192,192) | 44 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Edema: Day 28/ET Mild (n=190,192,192) | 71 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Edema: Day 28/ET Moderate (n=190,192,192) | 60 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Edema: Day 28/ET Severe (n=190,192,192) | 17 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Discharge: screening - None (n=192,197,192) | 51 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Discharge: screening - Mild (n=192,197,192) | 82 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Discharge:screening Moderate (n=192,197,192) | 51 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Discharge: screening Severe (n=192,197,192) | 13 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Discharge:Day 28/ET None (n=190,192,192) | 76 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Discharge:Day 28/ET Mild (n=190,192,192) | 85 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Discharge:Day 28/ET Moderate (n=190,192,192) | 24 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Discharge:Day 28/ET Severe (n=190,192,192) | 7 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Erythema screening None (n=192,197,192) | 108 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Erythema screening Mild (n=192,197,192) | 58 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Erythema screeningModerate (n=192,197,192) | 28 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Erythema screening Severe (n=192,197,192) | 3 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Erythema Day 28/ET None (n=190,192,192) | 124 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Erythema Day 28/ET Mild (n=190,192,192) | 46 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Erythema Day 28/ET Moderate (n=190,192,192 | 20 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Erythema Day 28/ET Severe (n=190,192,192) | 2 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Bleeding: screening None (n=192,197,192) | 192 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Bleeding: screening Mild (n=192,197,192) | 5 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Bleedingscreening Moderate (n=192,197,192) | 0 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Bleeding screening Severe (n=192,197,192) | 0 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Bleeding: Day 28/ET None (n=190,192,192) | 189 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Bleeding: Day 28/ET Mild (n=190,192,192) | 3 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Bleeding Day 28/ETModerate (n=190,192,192) | 0 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Bleeding: Day 28/ET Severe (n=190,192,192) | 0 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Crusting of Mucosa: screening Mild (n=192,197,192) | 13 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | CrustingofMucosa screening Moderate(n=192,197,192) | 6 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Crusting of Mucosa screening Severe(n=192,197,192) | 0 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Crusting of Mucosa:Day 28/ET None (n=190,192,192) | 178 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Crusting of Mucosa:Day 28/ET Mild (n=190,192,192) | 12 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | CrustingofMucosaDay 28/ET Moderate (n=190,192,192) | 2 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Crusting of Mucosa:Day 28/ET Severe(n=190,192,192) | 0 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Conjuntival screening None (n=192,197,192) | 145 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Conjuntival screening Mild (n=192,197,192) | 43 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Conjuntival screening Moderate n=(192,192, 192) | 9 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Conjuntival screeningSevere(n=192,197,192) | 0 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Conjuntival Day 28/ET None(n=190,192,192) | 145 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Conjuntival Day 28/ET Mild(n=190,192,192) | 34 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Conjuntival Day 28/ET Moderate(n=190,192) | 10 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Erythmatous TM: Day 28/ET Severe (n=190,192, 192) | 0 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Conjuntival Day 28/ET Severe (n=190,192, 192) | 3 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Erythmatous TM: screening None (n=192,197,192) | 183 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Erythmatous TM: screening Mild (n=192,197,192) | 8 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Erythmatous TM: screening Moderate(n=192,197,192) | 6 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Erythmatous TM:screening Severe (n=192,197,192) | 0 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Erythmatous TM: Day 28/ET None (n=190,192, 192) | 189 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Erythmatous TM: Day 28/ET Mild (n=190,192, 192) | 1 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Erythmatous TM: Day 28/ET Moderate (n=190,192,192) | 2 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Lymphadenopathy: screening None (n=192,197,192) | 189 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Lymphadenopathy: screening Mild (n=192,197,192) | 6 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Lymphadenopathy:screening Moderate (n=192,197,192) | 2 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Lymphadenopathy:screening Severe (n=192,197,192) | 0 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Lymphadenopathy: Day 28/ET None (n=190,192, 192) | 190 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Lymphadenopathy: Day 28/ET Mild (n=190,192, 192) | 1 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Lymphadenopathy Day 28/ET Moderate (n=190,192,192) | 1 Participants |
| Astepro 0.1% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Lymphadenopathy: Day 28/ET Severe ( n=190,192,192) | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Discharge: screening - None (n=192,197,192) | 49 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Irritationscreening Grade 1A (n=192,197,192) | 21 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Crusting of Mucosa:Day 28/ET None (n=190,192,192) | 175 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Edema: Day 28/ET Severe (n=190,192,192) | 19 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Epistaxis: screening - Mild (n=192,197,192) | 7 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Crusting of Mucosa:Day 28/ET Mild (n=190,192,192) | 16 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Edema: Day 28/ET Moderate (n=190,192,192) | 72 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Erythmatous TM: Day 28/ET Moderate (n=190,192,192) | 1 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | CrustingofMucosaDay 28/ET Moderate (n=190,192,192) | 1 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Edema: Day 28/ET Mild (n=190,192,192) | 71 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Irritation: screening - None (n=192,197,192) | 170 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Crusting of Mucosa:Day 28/ET Severe(n=190,192,192) | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Edema: Day 28/ET None (n=190,192,192) | 30 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Erythmatous TM: Day 28/ET Severe (n=190,192, 192) | 1 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Conjuntival screening None (n=192,197,192) | 134 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Edema: screening - Severe (n=192,197,192) | 24 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Epistaxis: Day 28/ET - Severe (n=190,192,192) | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Conjuntival screening Mild (n=192,197,192) | 48 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Edema: screening - Mild (n=192,197,192) | 50 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Epistaxis: Day 28/ET - None (n=190,192,192) | 188 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Conjuntival screening Moderate n=(192,192, 192) | 10 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Edema: screening - None (n=192,197,192) | 23 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Lymphadenopathy: screening None (n=192,197,192) | 188 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Conjuntival screeningSevere(n=192,197,192) | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Irritation Day 28/ETGrade 4 (n=190,192,192) | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Epistaxis: Day 28/ET - Moderate (n=190,192,192) | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Conjuntival Day 28/ET None(n=190,192,192) | 144 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Irritation Day 28/ETGrade 3 (n=190,192,192) | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Lymphadenopathy: Day 28/ET Mild (n=190,192, 192) | 3 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Conjuntival Day 28/ET Mild(n=190,192,192) | 36 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Irritation Day 28/ETGrade 2 (n=190,192,192) | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Epistaxis: Day 28/ET - Mild (n=190,192,192) | 4 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Epistaxis: screening - None (n=192,197,192) | 185 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Conjuntival Day 28/ET Moderate(n=190,192) | 11 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Irritation Day 28/ETGrade 1B (n=190,192,192) | 1 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Lymphadenopathy:screening Moderate (n=192,197,192) | 1 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Conjuntival Day 28/ET Severe (n=190,192, 192) | 1 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Irritation Day 28/ETGrade 1A (n=190,192,192) | 16 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Epistaxis: screening - Severe (n=192,197,192) | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Erythmatous TM: screening None (n=192,197,192) | 185 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Irritation Day 28/ET None (n=190,192,192) | 175 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Lymphadenopathy: Day 28/ET Severe ( n=190,192,192) | 1 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Erythmatous TM: screening Mild (n=192,197,192) | 5 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Irritation screening Grade 4 (n=192,197,192) | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Erythema Day 28/ET Moderate (n=190,192,192 | 26 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Erythema Day 28/ET Mild (n=190,192,192) | 51 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Lymphadenopathy:screening Severe (n=192,197,192) | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Erythema Day 28/ET Severe (n=190,192,192) | 4 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Erythema Day 28/ET None (n=190,192,192) | 111 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Erythmatous TM: screening Moderate(n=192,197,192) | 1 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Bleeding: screening None (n=192,197,192) | 183 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Erythema screening Severe (n=192,197,192) | 2 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Irritation screening Grade 3 (n=192,197,192) | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Bleeding: screening Mild (n=192,197,192) | 9 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Erythema screeningModerate (n=192,197,192) | 30 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Epistaxis: screening - Moderate (n=192,197,192) | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Bleedingscreening Moderate (n=192,197,192) | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Erythema screening Mild (n=192,197,192) | 54 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Erythmatous TM:screening Severe (n=192,197,192) | 1 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Bleeding screening Severe (n=192,197,192) | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Erythema screening None (n=192,197,192) | 106 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Irritationscreening Grade 2 (n=192,197,192) | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Bleeding: Day 28/ET None (n=190,192,192) | 184 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Discharge:Day 28/ET Severe (n=190,192,192) | 4 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Lymphadenopathy Day 28/ET Moderate (n=190,192,192) | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Bleeding: Day 28/ET Mild (n=190,192,192) | 7 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Discharge:Day 28/ET Moderate (n=190,192,192) | 35 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Erythmatous TM: Day 28/ET None (n=190,192, 192) | 187 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Bleeding Day 28/ETModerate (n=190,192,192) | 1 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Discharge:Day 28/ET Mild (n=190,192,192) | 72 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Irritation screening Grade1B (n=192,197,192) | 1 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Bleeding: Day 28/ET Severe (n=190,192,192) | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Discharge:Day 28/ET None (n=190,192,192) | 81 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Mucosal Edema: screening Moderate (n=192,197,192) | 95 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Crusting of Mucosa: screening None (n=192,197,192) | 173 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Discharge: screening Severe (n=192,197,192) | 11 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Lymphadenopathy: screening Mild (n=192,197,192) | 3 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Crusting of Mucosa: screening Mild (n=192,197,192) | 13 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Discharge:screening Moderate (n=192,197,192) | 49 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Lymphadenopathy: Day 28/ET None (n=190,192, 192) | 188 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | CrustingofMucosa screening Moderate(n=192,197,192) | 6 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Nasal Discharge: screening - Mild (n=192,197,192) | 83 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Erythmatous TM: Day 28/ET Mild (n=190,192, 192) | 3 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams and 28 Days | Crusting of Mucosa screening Severe(n=192,197,192) | 0 Participants |