Trial Outcomes & Findings for A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies (NCT NCT00660829)
NCT ID: NCT00660829
Last Updated: 2015-04-13
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 Means Square was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and baseline as co-variate
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
536 participants
Primary outcome timeframe
baseline and 14 days
Results posted on
2015-04-13
Participant Flow
First Observation December 13, 2007 Last Observation February 21, 2008
Participant milestones
| Measure |
Placebo
Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
|
Astepro 0.15%
0.15% Azelastine Hydrochloride Nasal Spray/2 sprays per nostril once daily for 14 days
|
|---|---|---|
|
Overall Study
STARTED
|
268
|
268
|
|
Overall Study
COMPLETED
|
250
|
249
|
|
Overall Study
NOT COMPLETED
|
18
|
19
|
Reasons for withdrawal
| Measure |
Placebo
Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
|
Astepro 0.15%
0.15% Azelastine Hydrochloride Nasal Spray/2 sprays per nostril once daily for 14 days
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
4
|
|
Overall Study
Lack of Efficacy
|
2
|
3
|
|
Overall Study
Non-Compliance
|
0
|
4
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
|
Overall Study
Other
|
9
|
4
|
Baseline Characteristics
A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies
Baseline characteristics by cohort
| Measure |
Placebo
n=266 Participants
Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
|
Astepro 0.15%
n=266 Participants
0.15% Azelastine Hydrochloride Nasal Spray/2 sprays per nostril once daily for 14 days
|
Total
n=532 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
14 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
241 Participants
n=5 Participants
|
230 Participants
n=7 Participants
|
471 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Age, Continuous
|
39.5 years
STANDARD_DEVIATION 14.41 • n=5 Participants
|
40.9 years
STANDARD_DEVIATION 14.51 • n=7 Participants
|
40.2 years
STANDARD_DEVIATION 14.46 • n=5 Participants
|
|
Sex: Female, Male
Female
|
171 Participants
n=5 Participants
|
175 Participants
n=7 Participants
|
346 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
95 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
186 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
266 participants
n=5 Participants
|
266 participants
n=7 Participants
|
532 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 14 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 Means Square was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and baseline as co-variate
Outcome measures
| Measure |
Placebo
n=266 Participants
Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
|
Astepro 0.15%
n=266 Participants
0.15% Azelastine Hydrochloride Nasal Spray/2 sprays per nostril once daily for 14 days
|
|---|---|---|
|
Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (TNSS) (AM and PM Combined)at 14 Days
Baseline symptom score
|
17.98 Scores on a scale
Standard Deviation 3.334
|
18.48 Scores on a scale
Standard Deviation 3.283
|
|
Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (TNSS) (AM and PM Combined)at 14 Days
Overall change from baseline
|
-1.97 Scores on a scale
Standard Deviation 3.510
|
-3.53 Scores on a scale
Standard Deviation 4.241
|
SECONDARY outcome
Timeframe: baseline and 14 daysEnd of 24 hour dosing interval: This endpoint is change from baseline in instantaneous (tNSS) for the 14-day study period compared to placebo to observe if the duration of efficacy lasts 24 hours on a day to day basis. Instantaneous (tNSS) consists of runny nose, itchy nose, nasal congestion, and sneezing. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe.Total possible score is 24 per day. Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and baseline as a covariate.
Outcome measures
| Measure |
Placebo
n=266 Participants
Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
|
Astepro 0.15%
n=266 Participants
0.15% Azelastine Hydrochloride Nasal Spray/2 sprays per nostril once daily for 14 days
|
|---|---|---|
|
Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (AM) for the Entire 14-day Study Period Compared to Placebo.
|
-0.66 Scores on a scale
Standard Error 1.859
|
-1.38 Scores on a scale
Standard Error 2.103
|
SECONDARY outcome
Timeframe: baseline and 14-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. Least Means Square was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and baseline as co-variate
Outcome measures
| Measure |
Placebo
n=266 Participants
Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
|
Astepro 0.15%
n=266 Participants
0.15% Azelastine Hydrochloride Nasal Spray/2 sprays per nostril once daily for 14 days
|
|---|---|---|
|
Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (AM and PM Combined) at 14 Days
Baseline symptom score
|
16.30 Scores on a scale
Standard Deviation 4.054
|
17.06 Scores on a scale
Standard Deviation 4.083
|
|
Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (AM and PM Combined) at 14 Days
Overall change from baseline
|
-1.52 Scores on a scale
Standard Deviation 3.622
|
-2.96 Scores on a scale
Standard Deviation 4.280
|
SECONDARY outcome
Timeframe: baseline and 14-daysReflective secondary complex symptom scores (SSCS) (post-nasal drip, itchy eyes, cough and headache) were assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible SSCS score is 24 per day. Least Means Square was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and baseline as co-variate
Outcome measures
| Measure |
Placebo
n=266 Participants
Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
|
Astepro 0.15%
n=266 Participants
0.15% Azelastine Hydrochloride Nasal Spray/2 sprays per nostril once daily for 14 days
|
|---|---|---|
|
Change From Baseline in 12-hour Reflective Secondary Symptom Complex Score (SSCS) for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined)
Baseline SSCS
|
14.40 Scores on a scale
Standard Deviation 4.960
|
14.83 Scores on a scale
Standard Deviation 4.709
|
|
Change From Baseline in 12-hour Reflective Secondary Symptom Complex Score (SSCS) for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined)
Change in baseline to Day 14
|
-1.52 Scores on a scale
Standard Deviation 3.388
|
-2.81 Scores on a scale
Standard Deviation 4.206
|
SECONDARY outcome
Timeframe: baseline and 14 DaysPopulation: ITT
A 28-item RQLQ was completed on Day 1 and Day 14 or Early termination. The RQLQ consists of 7 domains rated on a 7 point scale with 0 being not troubled by the allergy symptoms, and 6 being extremely troubled/all of the time. Scores for a series of subscales are not combined for a total overall score, rather domain score will be calculated from the mean score of all items in the domain. Overall score will be calculated from the mean score of all items.
Outcome measures
| Measure |
Placebo
n=266 Participants
Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
|
Astepro 0.15%
n=266 Participants
0.15% Azelastine Hydrochloride Nasal Spray/2 sprays per nostril once daily for 14 days
|
|---|---|---|
|
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
Baseline: Overall
|
3.68 Units on a scale
Standard Deviation 1.077
|
3.81 Units on a scale
Standard Deviation 1.059
|
|
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
Change from Baseline:Overall
|
-0.76 Units on a scale
Standard Deviation 1.219
|
-1.01 Units on a scale
Standard Deviation 1.304
|
SECONDARY outcome
Timeframe: baseline and 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 irritation was rated: 0 = None, Grade 1A = focal irritation, Grade 1B = superficial mucosal erosion, Grade 2 = moderate mucosal erosion, Grade 3 = ulceration, Grade 4 = septal perforation
Outcome measures
| Measure |
Placebo
n=268 Participants
Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
|
Astepro 0.15%
n=268 Participants
0.15% Azelastine Hydrochloride Nasal Spray/2 sprays per nostril once daily for 14 days
|
|---|---|---|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Nasal Irritation: Day 14/ET - none (n=265, 266)
|
248 Participants
|
251 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Nasal Irritation: Day 14/ET Grade 2 (n=265, 266)
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Nasal Irritation: Day 14/ET Grade 3 (n=265, 266)
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Nasal Irritation: Day 14/ET Grade 4 (n=265, 266)
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Mucosal Edema: screening - none (n= 268, 268)
|
18 Participants
|
14 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Mucosal Edema: screening - Mild (n= 268, 268)
|
55 Participants
|
48 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Mucosal Edema: screening - Moderate (n= 268, 268)
|
162 Participants
|
177 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Mucosal Edema: screening - Severe (n= 268, 268)
|
13 Participants
|
29 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Mucosal Edema: Day 14/ET none (n=265, 266)
|
6 Participants
|
17 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Mucosal Edema: Day 14/ET Mild (n=265, 266)
|
88 Participants
|
77 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Mucosal Edema: Day 14/ET Moderate (n=265, 266)
|
152 Participants
|
151 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Mucosal Edema: Day 14/ET Severe (n=265, 266)
|
19 Participants
|
21 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Nasal Discharge: screening - none (n= 268, 268)
|
63 Participants
|
58 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Nasal Discharge: screening - Mild (n= 268, 268)
|
112 Participants
|
116 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Nasal Discharge: screening -Moderate (n= 268, 268)
|
79 Participants
|
82 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Nasal Discharge: screening Severe(n= 268, 268)
|
14 Participants
|
12 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Nasal Discharge: Day 14/ET none (n=265, 266)
|
79 Participants
|
72 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Nasal Discharge: Day 14/ET Mild (n=265, 266)
|
122 Participants
|
128 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Nasal Discharge: Day 14/ET Moderate (n=265, 266)
|
64 Participants
|
62 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Nasal Discharge: Day 14/ET Severe (n=265, 266)
|
0 Participants
|
4 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Mucosal Erythema: screening none (n= 268, 268)
|
145 Participants
|
148 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Mucosal Erythema: screening Mild (n= 268, 268)
|
71 Participants
|
69 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Mucosal Erythema: screening Moderate (n= 268, 268)
|
50 Participants
|
48 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Mucosal Erythema: screening Severe (n= 268, 268)
|
2 Participants
|
3 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Mucosal Erythema: Day 14/ET none (n=265, 266)
|
153 Participants
|
157 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Mucosal Erythema: Day 14/ET Mild (n=265, 266)
|
66 Participants
|
63 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Mucosal Erythema: Day 14/ET Moderate (n=265, 266)
|
45 Participants
|
45 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Mucosal Erythema: Day 14/ET Severe (n=265, 266)
|
1 Participants
|
1 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Mucosal Bleeding: screening none (n= 268, 268)
|
257 Participants
|
259 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Mucosal Bleeding: screening Mild (n= 268, 268)
|
11 Participants
|
8 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Mucosal Bleeding: screening Moderate (n= 268, 268)
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Mucosal Bleeding: screening Severe (n= 268, 268)
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Mucosal Bleeding: Day 14/ET none (n=265, 266)
|
257 Participants
|
256 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Mucosal Bleeding: Day 14/ET Mild (n=265, 266)
|
8 Participants
|
10 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Mucosal Bleeding: Day 14/ET Moderate(n=265, 266)
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Mucosal Bleeding: Day 14/ET Severe (n=265, 266)
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Crusting of Mucosa: screening none (n= 268, 268)
|
237 Participants
|
245 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Crusting of Mucosa: screening Mild (n= 268, 268)
|
25 Participants
|
15 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Crusting of Mucosascreening Moderate (n= 268, 268)
|
6 Participants
|
7 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Crusting of Mucosa: screening Severe (n= 268, 268)
|
0 Participants
|
1 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Crusting of Mucosa: Day 14/ET - none (n=265, 266)
|
245 Participants
|
244 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Crusting of Mucosa: Day 14/ET - Mild (n=265, 266)
|
14 Participants
|
16 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Crusting of Mucosa:Day 14/ET Moderate (n=265, 266)
|
6 Participants
|
6 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Crusting of Mucosa Day 14/ET Severe( n=265, 266)
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Epistaxis: screening - None ( n=268, 268)
|
267 Participants
|
267 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Epistaxis: screening - Mild ( n=268, 268)
|
1 Participants
|
1 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Epistaxis: screening - Moderate ( n=268, 268)
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Epistaxis: screening - Severe ( n=268, 268)
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Epistaxis: Day 14/ET -None (n=265, 266)
|
264 Participants
|
265 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Epistaxis: Day 14/ET -Mild (n=265, 266)
|
1 Participants
|
1 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Epistaxis: Day 14/ET -Moderate (n=265, 266)
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Epistaxis: Day 14/ET -Severe (n=265, 266)
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Nasal Irritation: screening - None ( n=268, 268)
|
232 Participants
|
230 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Nasal Irritation: screening -Grade 1A ( n=268, 268
|
36 Participants
|
38 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Nasal Irritation: screening Grade 1B ( n=268, 268)
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Nasal Irritation: screening -Grade 2 ( n=268, 268)
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Nasal Irritation: screening -Grade 3 ( n=268, 268)
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Nasal Irritation: screening -Grade 4 ( n=268, 268)
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Nasal Irritation: Day 14/ET Grade 1A (n=265, 266)
|
15 Participants
|
15 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Nasal Irritation: Day 14/ET Grade 1B (n=265, 266)
|
2 Participants
|
0 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Astepro 0.15%
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=266 participants at risk
Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
|
Astepro 0.15%
n=266 participants at risk
0.15% Azelastine Hydrochloride Nasal Spray/2 sprays per nostril once daily for 14 days
|
|---|---|---|
|
Nervous system disorders
Dysgesusia
|
0.00%
0/266
|
4.5%
12/266 • Number of events 12
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Discomfort
|
0.00%
0/266
|
4.5%
12/266 • Number of events 12
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.3%
6/266 • Number of events 6
|
1.9%
5/266 • Number of events 5
|
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