Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of Two Nasal Sprays to Treat Seasonal Allergies (NCT NCT00720278)
NCT ID: NCT00720278
Last Updated: 2010-03-02
Results Overview
rTNSS consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. (maximum 12 points per assessment.) Total possible score is 24 per day. Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and baseline as a covariate.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
526 participants
Primary outcome timeframe
baseline and 14 days
Results posted on
2010-03-02
Participant Flow
First observation: 14 Aug 2007 Last observation: 19 Nov 2007
Subjects participated in a 7 day screening period to Identify appropriate subjects based on symptom scores.
Participant milestones
| Measure |
Placebo
Placebo Nasal Spray taken 2 sprays per nostril twice a day for 14 days
|
Astepro 0.1%
0.1% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
|
Astepro 0.15%
0.15% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
|
|---|---|---|---|
|
Overall Study
STARTED
|
178
|
170
|
178
|
|
Overall Study
COMPLETED
|
171
|
166
|
172
|
|
Overall Study
NOT COMPLETED
|
7
|
4
|
6
|
Reasons for withdrawal
| Measure |
Placebo
Placebo Nasal Spray taken 2 sprays per nostril twice a day for 14 days
|
Astepro 0.1%
0.1% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
|
Astepro 0.15%
0.15% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
5
|
3
|
4
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
|
Overall Study
Non-compliance
|
1
|
0
|
0
|
|
Overall Study
eligibility criteria violation
|
1
|
0
|
1
|
Baseline Characteristics
A Study to Evaluate the Safety and Efficacy of Two Nasal Sprays to Treat Seasonal Allergies
Baseline characteristics by cohort
| Measure |
Placebo
n=177 Participants
Placebo Nasal Spray taken 2 sprays per nostril twice a day for 14 days
|
Astepro 0.1%
n=169 Participants
0.1% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
|
Astepro 0.15%
n=177 Participants
0.15% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
|
Total
n=523 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
24 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
148 Participants
n=5 Participants
|
151 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
455 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Age Continuous
|
36.9 years
STANDARD_DEVIATION 14.27 • n=5 Participants
|
35.4 years
STANDARD_DEVIATION 13.74 • n=7 Participants
|
37.7 years
STANDARD_DEVIATION 14.64 • n=5 Participants
|
36.7 years
STANDARD_DEVIATION 14.23 • n=4 Participants
|
|
Sex: Female, Male
Female
|
116 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
334 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
189 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
177 participants
n=5 Participants
|
169 participants
n=7 Participants
|
177 participants
n=5 Participants
|
523 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: baseline and 14 daysrTNSS consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. (maximum 12 points per assessment.) Total possible score is 24 per day. Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and baseline as a covariate.
Outcome measures
| Measure |
Astepro 0.1%
n=166 Participants
0.1% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
|
Astepro 0.15%
n=172 Participants
0.15% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
|
Placebo
n=171 Participants
Placebo Nasal Spray taken 2 sprays per nostril twice a day for 14 days
|
|---|---|---|---|
|
Change From Baseline in 12-hour Reflective Total Nasal Symptom Score(rTNSS)for the Entire 14-day Study Period Compared to Placebo
Baseline symptom score
|
18.29 total nasal symptom score
Standard Deviation 3.23
|
17.83 total nasal symptom score
Standard Deviation 3.284
|
17.86 total nasal symptom score
Standard Deviation 3.301
|
|
Change From Baseline in 12-hour Reflective Total Nasal Symptom Score(rTNSS)for the Entire 14-day Study Period Compared to Placebo
Overall change from baseline
|
-4.42 total nasal symptom score
Standard Deviation 4.696
|
-5.36 total nasal symptom score
Standard Deviation 5.077
|
-2.36 total nasal symptom score
Standard Deviation 4.155
|
SECONDARY outcome
Timeframe: baseline and 14 Daysinstantaneous (subjects rate how they feel "right now") total nasal symptom score consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day. Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate.
Outcome measures
| Measure |
Astepro 0.1%
n=166 Participants
0.1% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
|
Astepro 0.15%
n=172 Participants
0.15% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
|
Placebo
n=171 Participants
Placebo Nasal Spray taken 2 sprays per nostril twice a day for 14 days
|
|---|---|---|---|
|
Change From Baseline in Instantaneous Total Nasal Symptom Score for the Entire 14-day Study Period Compared to Placebo
Baseline symptom score
|
17.22 total nasal symptom score
Standard Deviation 3.836
|
16.43 total nasal symptom score
Standard Deviation 3.998
|
16.56 total nasal symptom score
Standard Deviation 3.962
|
|
Change From Baseline in Instantaneous Total Nasal Symptom Score for the Entire 14-day Study Period Compared to Placebo
Overall change from baseline
|
-3.74 total nasal symptom score
Standard Deviation 4.796
|
-4.63 total nasal symptom score
Standard Deviation 5.261
|
-1.96 total nasal symptom score
Standard Deviation 4.313
|
SECONDARY outcome
Timeframe: baseline and 14 daysReflective secondary symptom scores (SSCS) (post-nasal drip, itchy eyes, cough and headache) were assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible SSCS score is 24 per day. Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate.
Outcome measures
| Measure |
Astepro 0.1%
n=166 Participants
0.1% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
|
Astepro 0.15%
n=172 Participants
0.15% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
|
Placebo
n=171 Participants
Placebo Nasal Spray taken 2 sprays per nostril twice a day for 14 days
|
|---|---|---|---|
|
Change From Baseline in the 12-hour Reflective Secondary Symptom Complex Score for the Entire 14-day Study Period Compared to Placebo
Baseline SSCS
|
14.59 Reflective secondary symptom score
Standard Deviation 4.818
|
13.59 Reflective secondary symptom score
Standard Deviation 5.087
|
14.27 Reflective secondary symptom score
Standard Deviation 4.503
|
|
Change From Baseline in the 12-hour Reflective Secondary Symptom Complex Score for the Entire 14-day Study Period Compared to Placebo
Change in baseline to Day 14
|
-3.09 Reflective secondary symptom score
Standard Deviation 4.337
|
-4.15 Reflective secondary symptom score
Standard Deviation 4.600
|
-1.72 Reflective secondary symptom score
Standard Deviation 3.823
|
SECONDARY outcome
Timeframe: baseline and 14 daysA 28-item RQLQ was completed on Day 1 and Day 14 or Early temination. The RQLQ consists of 7 domains rated on a 7 point scale with 0 being not troubled by the allergy symptoms, and 6 being extremely troubled/all of the time. Domain score will be calculated from the mean score of all items in the domain. Overall score will be calculated from the mean score of all items.
Outcome measures
| Measure |
Astepro 0.1%
n=166 Participants
0.1% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
|
Astepro 0.15%
n=172 Participants
0.15% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
|
Placebo
n=171 Participants
Placebo Nasal Spray taken 2 sprays per nostril twice a day for 14 days
|
|---|---|---|---|
|
Change From Baseline to Day 14 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Patients 18 Years of Age and Older
Baseline: Overall
|
3.73 28 item/7 domain RQLQ on 0-6 scale
Standard Deviation 0.998
|
3.75 28 item/7 domain RQLQ on 0-6 scale
Standard Deviation 1.012
|
3.87 28 item/7 domain RQLQ on 0-6 scale
Standard Deviation 0.991
|
|
Change From Baseline to Day 14 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Patients 18 Years of Age and Older
Change from Baseline:Overall
|
-1.12 28 item/7 domain RQLQ on 0-6 scale
Standard Deviation 1.246
|
-1.48 28 item/7 domain RQLQ on 0-6 scale
Standard Deviation 1.328
|
-0.94 28 item/7 domain RQLQ on 0-6 scale
Standard Deviation 1.112
|
SECONDARY outcome
Timeframe: 14 daysExamination 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 |
Astepro 0.1%
n=166 Participants
0.1% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
|
Astepro 0.15%
n=172 Participants
0.15% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
|
Placebo
n=171 Participants
Placebo Nasal Spray taken 2 sprays per nostril twice a day for 14 days
|
|---|---|---|---|
|
Change From Baseline on Direct Visual Nasal Exams
Nasal Discharge: Day 14/ET - Severe
|
6 Participants
|
11 Participants
|
10 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Mucosal Erythema: screening - Total
|
170 Participants
|
178 Participants
|
178 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Mucosal Erythema: screening - None
|
74 Participants
|
92 Participants
|
81 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Mucosal Erythema: screening - Mild
|
56 Participants
|
45 Participants
|
59 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Nasal Discharge: Day 14/ET - None
|
46 Participants
|
47 Participants
|
26 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Nasal Discharge: Day 14/ET- Mild
|
71 Participants
|
72 Participants
|
85 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Nasal Discharge: Day 14/ET - Moderate
|
46 Participants
|
45 Participants
|
47 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Mucosal Erythema: Day 14/ET - Moderate
|
18 Participants
|
27 Participants
|
25 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Mucosal Erythema: Day 14/ET - Severe
|
5 Participants
|
1 Participants
|
1 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Mucosal Bleeding: screening - Toal
|
170 Participants
|
178 Participants
|
178 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Mucosal Bleeding: screening - None
|
167 Participants
|
167 Participants
|
175 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Mucosal Bleeding: screening - Mild
|
3 Participants
|
2 Participants
|
3 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Mucosal Bleeding: screening - Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Mucosal Bleeding: screening - Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Mucosal Bleeding: Day 14/ET - Total
|
169 Participants
|
175 Participants
|
178 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Mucosal Bleeding: Day 14/ET - None
|
163 Participants
|
163 Participants
|
171 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Mucosal Bleeding: Day 14/ET - Mild
|
6 Participants
|
11 Participants
|
7 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Mucosal Bleeding: Day 14/ET - Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Mucosal Bleeding: Day 14/ET - Severe
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Crusting of Mucosa: screening - Total
|
170 Participants
|
178 Participants
|
178 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Crusting of Mucosa: screening - None
|
142 Participants
|
158 Participants
|
156 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Crusting of Mucosa: screening - Mild
|
20 Participants
|
18 Participants
|
17 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Crusting of Mucosa: screening - Moderate
|
7 Participants
|
2 Participants
|
4 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Crusting of Mucosa: screening - Severe
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Mucosal Erythema: screening - Moderate
|
37 Participants
|
39 Participants
|
37 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Mucosal Erythema: screening - Severe
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Mucosal Erythema: Day 14/ET - Toal
|
167 Participants
|
175 Participants
|
178 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Mucosal Erythema: Day 14/ET - None
|
97 Participants
|
105 Participants
|
101 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Mucosal Erythema: Day 14/ET - Mild
|
49 Participants
|
42 Participants
|
51 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Crusting of Mucosa: Day 14/ET - Moderate
|
2 Participants
|
3 Participants
|
4 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Crusting of Mucosa: Day 14/ET - Severe
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Crusting of Mucosa: Day 14/ET - Total
|
169 Participants
|
175 Participants
|
178 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Crusting of Mucosa: Day 14/ET - None
|
148 Participants
|
155 Participants
|
154 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Crusting of Mucosa: Day 14/ET - Mild
|
19 Participants
|
16 Participants
|
19 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Nasal Discharge: screening - Total
|
170 Participants
|
178 Participants
|
178 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Nasal Discharge: screening - None
|
26 Participants
|
28 Participants
|
29 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Nasal Discharge: screening - Mild
|
63 Participants
|
67 Participants
|
72 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Nasal Discharge: screening - Moderate
|
67 Participants
|
71 Participants
|
64 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Nasal Discharge: screening - Severe
|
14 Participants
|
12 Participants
|
13 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Nasal Discharge: Day 14/ET - Total
|
169 Participants
|
175 Participants
|
178 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Epistaxis: screening - total
|
170 Participants
|
178 Participants
|
178 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Epistaxis: screening - None
|
169 Participants
|
176 Participants
|
176 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Epistaxis: screening - Mild
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Epistaxis: screening - Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Epistaxis: screening - Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Epistaxis: Day 14/ET - total
|
169 Participants
|
175 Participants
|
178 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Epistaxis: Day 14/ET - None
|
168 Participants
|
166 Participants
|
174 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Epistaxis: Day 14/ET - Mild
|
1 Participants
|
9 Participants
|
4 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Epistaxis: Day 14/ET - Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Epistaxis: Day 14/ET - Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Nasal Irritation: screening - total
|
0 Participants
|
0 Participants
|
178 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Nasal Irritation: screening - None
|
170 Participants
|
178 Participants
|
169 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Nasal Irritation: screening - Grade 1A
|
166 Participants
|
169 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Nasal Irritation: screening - Grade 1B
|
4 Participants
|
9 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Nasal Irritation: screening - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Nasal Irritation: screening - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Nasal Irritation: screening - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Nasal Irritation: Day 14/ET - Total
|
169 Participants
|
175 Participants
|
178 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Nasal Irritation: Day 14/ET - None
|
161 Participants
|
165 Participants
|
168 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Nasal Irritation: Day 14/ET- Grade 1A
|
8 Participants
|
7 Participants
|
8 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Nasal Irritation: Day 14/ET- Grade 1B
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Nasal Irritation: Day 14/ET- Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Nasal Irritation: Day 14/ET- Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Nasal Irritation: Day 14/ET- Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Mucosal Edema: screening - Total
|
170 Participants
|
178 Participants
|
178 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Mucosal Edema: screening - None
|
3 Participants
|
3 Participants
|
3 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Mucosal Edema: screening - Mild
|
30 Participants
|
28 Participants
|
40 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Mucosal Edema: screening - Moderate
|
106 Participants
|
114 Participants
|
108 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Mucosal Edema: screening - Severe
|
31 Participants
|
33 Participants
|
27 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Mucosal Edema: Day 14/ET - total
|
169 Participants
|
175 Participants
|
178 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Mucosal Edema: Day 14/ET - None
|
12 Participants
|
15 Participants
|
14 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Mucosal Edema: Day 14/ET - Mild
|
60 Participants
|
59 Participants
|
50 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Mucosal Edema: Day 14/ET - Moderate
|
77 Participants
|
81 Participants
|
88 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams
Mucosal Edema: Day 14/ET - Severe
|
20 Participants
|
20 Participants
|
26 Participants
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Astepro 0.1%
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Astepro 0.15%
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=178 participants at risk
Placebo Nasal Spray taken 2 sprays per nostril twice a day for 14 days
|
Astepro 0.1%
n=170 participants at risk
0.1% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
|
Astepro 0.15%
n=178 participants at risk
0.15% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
|
|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Exposure in utero
|
0.56%
1/178 • Number of events 1
|
0.00%
0/170
|
0.00%
0/178
|
|
Infections and infestations
Pneumonia
|
0.56%
1/178 • Number of events 1
|
0.00%
0/170
|
0.00%
0/178
|
Other adverse events
| Measure |
Placebo
n=178 participants at risk
Placebo Nasal Spray taken 2 sprays per nostril twice a day for 14 days
|
Astepro 0.1%
n=170 participants at risk
0.1% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
|
Astepro 0.15%
n=178 participants at risk
0.15% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
|
|---|---|---|---|
|
Nervous system disorders
Dysgesusia
|
1.1%
2/178 • Number of events 2
|
9.4%
16/170 • Number of events 16
|
8.4%
15/178 • Number of events 15
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Discomfort
|
1.7%
3/178 • Number of events 3
|
2.9%
5/170 • Number of events 5
|
2.2%
4/178 • Number of events 4
|
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