Trial Outcomes & Findings for A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Perennial Allergies (NCT NCT00712920)
NCT ID: NCT00712920
Last Updated: 2011-06-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
581 participants
Primary outcome timeframe
baseline and 28 days
Results posted on
2011-06-08
Participant Flow
First Observation: February 5, 2007 Last Observation: October 8, 2007
Subjects participated in a 7 day screening period to Identify appropriate subjects based on symptom scores.
Participant milestones
| Measure |
Placebo
Placebo nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
|
Astepro 0.1%
0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
|
Astepro 0.15%
0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
192
|
197
|
192
|
|
Overall Study
COMPLETED
|
175
|
180
|
180
|
|
Overall Study
NOT COMPLETED
|
17
|
17
|
12
|
Reasons for withdrawal
| Measure |
Placebo
Placebo nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
|
Astepro 0.1%
0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
|
Astepro 0.15%
0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
4
|
7
|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
4
|
0
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
1
|
|
Overall Study
Other
|
5
|
7
|
3
|
|
Overall Study
Non-compliance
|
3
|
0
|
0
|
Baseline Characteristics
A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Perennial Allergies
Baseline characteristics by cohort
| Measure |
Placebo
n=192 Participants
Placebo nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
|
Astepro 0.1%
n=194 Participants
0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
|
Astepro 0.15%
n=192 Participants
0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
|
Total
n=578 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
21 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
161 Participants
n=5 Participants
|
183 Participants
n=7 Participants
|
170 Participants
n=5 Participants
|
514 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Age Continuous
|
38.1 years
STANDARD_DEVIATION 15.37 • n=5 Participants
|
36.9 years
STANDARD_DEVIATION 13.09 • n=7 Participants
|
35.6 years
STANDARD_DEVIATION 13.31 • n=5 Participants
|
36.9 years
STANDARD_DEVIATION 13.97 • n=4 Participants
|
|
Sex: Female, Male
Female
|
130 Participants
n=5 Participants
|
136 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
393 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
185 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
192 participants
n=5 Participants
|
194 participants
n=7 Participants
|
192 participants
n=5 Participants
|
578 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: baseline and 28 daysPopulation: ITT
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.
Outcome measures
| Measure |
Placebo
n=192 Participants
Placebo nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
|
Astepro 0.1%
n=194 Participants
0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
|
Astepro 0.15%
n=192 Participants
0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
|
|---|---|---|---|
|
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
0.0
|
15.5 Scores on a Scale
0.0
|
15.8 Scores on a Scale
0.0
|
|
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
0.0
|
-3.8 Scores on a Scale
0.0
|
-4.0 Scores on a Scale
0.0
|
SECONDARY outcome
Timeframe: baseline and 28 daysPopulation: ITT
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.
Outcome measures
| Measure |
Placebo
n=192 Participants
Placebo nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
|
Astepro 0.1%
n=194 Participants
0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
|
Astepro 0.15%
n=192 Participants
0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
|
|---|---|---|---|
|
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
|
13.91 Scores on a Scale
Standard Deviation 4.616
|
14.30 Scores on a Scale
Standard Deviation 4.572
|
|
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
|
-3.36 Scores on a Scale
Standard Deviation 3.898
|
-3.51 Scores on a Scale
Standard Deviation 4.166
|
SECONDARY outcome
Timeframe: baseline and 28 daysPopulation: ITT
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.
Outcome measures
| Measure |
Placebo
n=192 Participants
Placebo nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
|
Astepro 0.1%
n=194 Participants
0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
|
Astepro 0.15%
n=192 Participants
0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
|
|---|---|---|---|
|
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
|
11.77 Scores on a Scale
Standard Deviation 5.036
|
12.39 Scores on a Scale
Standard Deviation 4.885
|
|
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 3.420
|
-2.23 Scores on a Scale
Standard Deviation 3.865
|
-2.92 Scores on a Scale
Standard Deviation 4.053
|
SECONDARY outcome
Timeframe: baseline and 28 DaysPopulation: ITT
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.
Outcome measures
| Measure |
Placebo
n=192 Participants
Placebo nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
|
Astepro 0.1%
n=194 Participants
0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
|
Astepro 0.15%
n=192 Participants
0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
|
|---|---|---|---|
|
Change From Baseline in Rinoconjunctivitis Quality of Life Questionnaire and 28 Days
Baseline: Overall
|
2.98 Units on a Scale
Standard Deviation 1.047
|
3.18 Units on a Scale
Standard Deviation 1.048
|
3.29 Units on a Scale
Standard Deviation 1.091
|
|
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
|
-1.05 Units on a Scale
Standard Deviation 1.088
|
-0.94 Units on a Scale
Standard Deviation 1.096
|
SECONDARY outcome
Timeframe: baseline and 28 daysPopulation: ITT
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
Outcome measures
| Measure |
Placebo
n=192 Participants
Placebo nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
|
Astepro 0.1%
n=194 Participants
0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
|
Astepro 0.15%
n=192 Participants
0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
|
|---|---|---|---|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Lymphadenopathy:screening Moderate (n=192,197,192)
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Lymphadenopathy:screening Severe (n=192,197,192)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Lymphadenopathy: Day 28/ET None (n=190,192, 192)
|
184 Participants
|
190 Participants
|
188 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Lymphadenopathy: Day 28/ET Mild (n=190,192, 192)
|
5 Participants
|
1 Participants
|
3 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Epistaxis: screening - None (n=192,197,192)
|
189 Participants
|
194 Participants
|
185 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Epistaxis: screening - Mild (n=192,197,192)
|
3 Participants
|
3 Participants
|
7 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Epistaxis: screening - Moderate (n=192,197,192)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Epistaxis: screening - Severe (n=192,197,192)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Epistaxis: Day 28/ET - None (n=190,192,192)
|
188 Participants
|
189 Participants
|
188 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Epistaxis: Day 28/ET - Mild (n=190,192,192)
|
2 Participants
|
3 Participants
|
4 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Epistaxis: Day 28/ET - Moderate (n=190,192,192)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Epistaxis: Day 28/ET - Severe (n=190,192,192)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Nasal Irritation: screening - None (n=192,197,192)
|
180 Participants
|
183 Participants
|
170 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Nasal Irritationscreening Grade 1A (n=192,197,192)
|
8 Participants
|
12 Participants
|
21 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Nasal Irritation screening Grade1B (n=192,197,192)
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Nasal Irritationscreening Grade 2 (n=192,197,192)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Nasal Irritation screening Grade 3 (n=192,197,192)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Nasal Irritation screening Grade 4 (n=192,197,192)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Nasal Irritation Day 28/ET None (n=190,192,192)
|
182 Participants
|
178 Participants
|
175 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Nasal Irritation Day 28/ETGrade 1A (n=190,192,192)
|
7 Participants
|
12 Participants
|
16 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Nasal Irritation Day 28/ETGrade 1B (n=190,192,192)
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Nasal Irritation Day 28/ETGrade 2 (n=190,192,192)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Nasal Irritation Day 28/ETGrade 3 (n=190,192,192)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Nasal Irritation Day 28/ETGrade 4 (n=190,192,192)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Mucosal Edema: screening - None (n=192,197,192)
|
25 Participants
|
30 Participants
|
23 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Mucosal Edema: screening - Mild (n=192,197,192)
|
50 Participants
|
54 Participants
|
50 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Mucosal Edema: screening Moderate (n=192,197,192)
|
98 Participants
|
84 Participants
|
95 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Mucosal Edema: screening - Severe (n=192,197,192)
|
19 Participants
|
29 Participants
|
24 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Mucosal Edema: Day 28/ET None (n=190,192,192)
|
38 Participants
|
44 Participants
|
30 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Mucosal Edema: Day 28/ET Mild (n=190,192,192)
|
69 Participants
|
71 Participants
|
71 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Mucosal Edema: Day 28/ET Moderate (n=190,192,192)
|
70 Participants
|
60 Participants
|
72 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Mucosal Edema: Day 28/ET Severe (n=190,192,192)
|
13 Participants
|
17 Participants
|
19 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Nasal Discharge: screening - None (n=192,197,192)
|
55 Participants
|
51 Participants
|
49 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Nasal Discharge: screening - Mild (n=192,197,192)
|
79 Participants
|
82 Participants
|
83 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Nasal Discharge:screening Moderate (n=192,197,192)
|
48 Participants
|
51 Participants
|
49 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Nasal Discharge: screening Severe (n=192,197,192)
|
10 Participants
|
13 Participants
|
11 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Nasal Discharge:Day 28/ET None (n=190,192,192)
|
77 Participants
|
76 Participants
|
81 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Nasal Discharge:Day 28/ET Mild (n=190,192,192)
|
75 Participants
|
85 Participants
|
72 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Nasal Discharge:Day 28/ET Moderate (n=190,192,192)
|
31 Participants
|
24 Participants
|
35 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Nasal Discharge:Day 28/ET Severe (n=190,192,192)
|
7 Participants
|
7 Participants
|
4 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Mucosal Erythema screening None (n=192,197,192)
|
91 Participants
|
108 Participants
|
106 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Mucosal Erythema screening Mild (n=192,197,192)
|
61 Participants
|
58 Participants
|
54 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Mucosal Erythema screeningModerate (n=192,197,192)
|
37 Participants
|
28 Participants
|
30 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Mucosal Erythema screening Severe (n=192,197,192)
|
3 Participants
|
3 Participants
|
2 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Mucosal Erythema Day 28/ET None (n=190,192,192)
|
101 Participants
|
124 Participants
|
111 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Mucosal Erythema Day 28/ET Mild (n=190,192,192)
|
64 Participants
|
46 Participants
|
51 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Mucosal Erythema Day 28/ET Moderate (n=190,192,192
|
23 Participants
|
20 Participants
|
26 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Mucosal Erythema Day 28/ET Severe (n=190,192,192)
|
2 Participants
|
2 Participants
|
4 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Mucosal Bleeding: screening None (n=192,197,192)
|
185 Participants
|
192 Participants
|
183 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Mucosal Bleeding: screening Mild (n=192,197,192)
|
7 Participants
|
5 Participants
|
9 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Mucosal Bleedingscreening Moderate (n=192,197,192)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Mucosal Bleeding screening Severe (n=192,197,192)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Mucosal Bleeding: Day 28/ET None (n=190,192,192)
|
189 Participants
|
189 Participants
|
184 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Mucosal Bleeding: Day 28/ET Mild (n=190,192,192)
|
1 Participants
|
3 Participants
|
7 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Mucosal Bleeding Day 28/ETModerate (n=190,192,192)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Mucosal Bleeding: Day 28/ET Severe (n=190,192,192)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Crusting of Mucosa: screening None (n=192,197,192)
|
173 Participants
|
178 Participants
|
173 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Crusting of Mucosa: screening Mild (n=192,197,192)
|
15 Participants
|
13 Participants
|
13 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
CrustingofMucosa screening Moderate(n=192,197,192)
|
4 Participants
|
6 Participants
|
6 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Crusting of Mucosa screening Severe(n=192,197,192)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Crusting of Mucosa:Day 28/ET None (n=190,192,192)
|
176 Participants
|
178 Participants
|
175 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Crusting of Mucosa:Day 28/ET Mild (n=190,192,192)
|
14 Participants
|
12 Participants
|
16 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
CrustingofMucosaDay 28/ET Moderate (n=190,192,192)
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Crusting of Mucosa:Day 28/ET Severe(n=190,192,192)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Conjuntival screening None (n=192,197,192)
|
126 Participants
|
145 Participants
|
134 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Conjuntival screening Mild (n=192,197,192)
|
56 Participants
|
43 Participants
|
48 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Conjuntival screening Moderate n=(192,192, 192)
|
10 Participants
|
9 Participants
|
10 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Conjuntival screeningSevere(n=192,197,192)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Conjuntival Day 28/ET None(n=190,192,192)
|
125 Participants
|
145 Participants
|
144 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Conjuntival Day 28/ET Mild(n=190,192,192)
|
57 Participants
|
34 Participants
|
36 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Conjuntival Day 28/ET Moderate(n=190,192)
|
6 Participants
|
10 Participants
|
11 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Conjuntival Day 28/ET Severe (n=190,192, 192)
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Erythmatous TM: screening None (n=192,197,192)
|
180 Participants
|
183 Participants
|
185 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Erythmatous TM: screening Mild (n=192,197,192)
|
9 Participants
|
8 Participants
|
5 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Erythmatous TM: screening Moderate(n=192,197,192)
|
2 Participants
|
6 Participants
|
1 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Erythmatous TM:screening Severe (n=192,197,192)
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Erythmatous TM: Day 28/ET None (n=190,192, 192)
|
179 Participants
|
189 Participants
|
187 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Erythmatous TM: Day 28/ET Mild (n=190,192, 192)
|
8 Participants
|
1 Participants
|
3 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Erythmatous TM: Day 28/ET Moderate (n=190,192,192)
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Erythmatous TM: Day 28/ET Severe (n=190,192, 192)
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Lymphadenopathy: screening None (n=192,197,192)
|
186 Participants
|
189 Participants
|
188 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Lymphadenopathy: screening Mild (n=192,197,192)
|
4 Participants
|
6 Participants
|
3 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Lymphadenopathy Day 28/ET Moderate (n=190,192,192)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Lymphadenopathy: Day 28/ET Severe ( n=190,192,192)
|
0 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Astepro 0.1%
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Astepro 0.15%
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=192 participants at risk
Placebo nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
|
Astepro 0.1%
n=194 participants at risk
0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
|
Astepro 0.15%
n=192 participants at risk
0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Nasal Discomfort
|
3.6%
7/192 • Number of events 7
0 participants were at risk for an SAE. No SAE's were observed
|
3.6%
7/194 • Number of events 7
0 participants were at risk for an SAE. No SAE's were observed
|
6.8%
13/192 • Number of events 13
0 participants were at risk for an SAE. No SAE's were observed
|
|
Nervous system disorders
Dysgesusia
|
0.52%
1/192 • Number of events 1
0 participants were at risk for an SAE. No SAE's were observed
|
5.7%
11/194 • Number of events 11
0 participants were at risk for an SAE. No SAE's were observed
|
4.7%
9/192 • Number of events 9
0 participants were at risk for an SAE. No SAE's were observed
|
|
Nervous system disorders
Headache
|
3.1%
6/192 • Number of events 6
0 participants were at risk for an SAE. No SAE's were observed
|
2.1%
4/194 • Number of events 4
0 participants were at risk for an SAE. No SAE's were observed
|
0.52%
1/192 • Number of events 1
0 participants were at risk for an SAE. No SAE's were observed
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.6%
3/192 • Number of events 3
0 participants were at risk for an SAE. No SAE's were observed
|
2.1%
4/194 • Number of events 4
0 participants were at risk for an SAE. No SAE's were observed
|
1.0%
2/192 • Number of events 2
0 participants were at risk for an SAE. No SAE's were observed
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/192
0 participants were at risk for an SAE. No SAE's were observed
|
0.00%
0/194
0 participants were at risk for an SAE. No SAE's were observed
|
2.6%
5/192 • Number of events 5
0 participants were at risk for an SAE. No SAE's were observed
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Infection
|
2.1%
4/192 • Number of events 4
0 participants were at risk for an SAE. No SAE's were observed
|
0.52%
1/194 • Number of events 1
0 participants were at risk for an SAE. No SAE's were observed
|
1.0%
2/192 • Number of events 2
0 participants were at risk for an SAE. No SAE's were observed
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee For multicenter studies, joint publication is required to assure that the initial publication is based on all data from all sites and investigators participating in these studies agree not to present data gathered individually or by subgroup centers before the initial publication unless jointly agreed by all other investigators and the sponsor. authorship will be determined by mutual agreement.
- Publication restrictions are in place
Restriction type: OTHER