Trial Outcomes & Findings for A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies (NCT NCT00824473)
NCT ID: NCT00824473
Last Updated: 2010-02-23
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 basline as a covariate.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
506 participants
Primary outcome timeframe
baseline and 14 days
Results posted on
2010-02-23
Participant Flow
First observation: 30 Dec 2008 Last observation: 13 Feb 2009
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 once a day for 14 days
|
Astepro 0.15%
0.15% azelastine hydrochloride Nasal Spray/2 sprays per nostril once a day for 14 days
|
|---|---|---|
|
Overall Study
STARTED
|
255
|
251
|
|
Overall Study
COMPLETED
|
240
|
238
|
|
Overall Study
NOT COMPLETED
|
15
|
13
|
Reasons for withdrawal
| Measure |
Placebo
Placebo Nasal Spray/2 sprays per nostril once a day for 14 days
|
Astepro 0.15%
0.15% azelastine hydrochloride Nasal Spray/2 sprays per nostril once a day for 14 days
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
5
|
|
Overall Study
Lack of Efficacy
|
2
|
2
|
|
Overall Study
Protocol Violation
|
2
|
0
|
|
Overall Study
Non-Compliance
|
4
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
|
Overall Study
Other
|
1
|
1
|
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=254 Participants
Placebo Nasal Spray/2 sprays per nostril once a day for 14 days
|
Astepro 0.15%
n=251 Participants
0.15% azelastine hydrochloride Nasal Spray/2 sprays per nostril once a day for 14 days
|
Total
n=505 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
27 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
220 Participants
n=5 Participants
|
218 Participants
n=7 Participants
|
438 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age Continuous
|
38.5 years
STANDARD_DEVIATION 14.59 • n=5 Participants
|
38.0 years
STANDARD_DEVIATION 14.40 • n=7 Participants
|
38.2 years
STANDARD_DEVIATION 14.48 • n=5 Participants
|
|
Sex: Female, Male
Female
|
150 Participants
n=5 Participants
|
157 Participants
n=7 Participants
|
307 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
104 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
198 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
254 participants
n=5 Participants
|
251 participants
n=7 Participants
|
505 participants
n=5 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 basline as a covariate.
Outcome measures
| Measure |
Placebo
n=255 Participants
Placebo Nasal Spray/2 sprays per nostril once a day for 14 days
|
Astepro 0.15%
n=251 Participants
0.15% azelastine hydrochloride Nasal Spray/2 sprays per nostril once 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 (AM and PM Combined)at 14 Days
Baseline symptom score
|
18.76 Scores on a scale
Standard Deviation 3.301
|
18.48 Scores on a scale
Standard Deviation 3.231
|
|
Change From Baseline in 12-hour Reflective Total Nasal Symptom Score(rTNSS)for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined)at 14 Days
Overall change from baseline
|
-2.14 Scores on a scale
Standard Deviation 3.696
|
-3.57 Scores on a scale
Standard Deviation 4.242
|
SECONDARY outcome
Timeframe: baseline to 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. 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=255 Participants
Placebo Nasal Spray/2 sprays per nostril once a day for 14 days
|
Astepro 0.15%
n=251 Participants
0.15% azelastine hydrochloride Nasal Spray/2 sprays per nostril once a day for 14 days
|
|---|---|---|
|
Mean Change From Baseline in Instantaneous Total Nasal Symptom Sscore (AM) for the Entire 14-day Study Period Compared to Placebo
|
-0.83 Score on a scale
Standard Deviation 1.842
|
-1.43 Score on a scale
Standard Deviation 2.088
|
SECONDARY outcome
Timeframe: baseline to 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 |
Placebo
n=255 Participants
Placebo Nasal Spray/2 sprays per nostril once a day for 14 days
|
Astepro 0.15%
n=251 Participants
0.15% azelastine hydrochloride Nasal Spray/2 sprays per nostril once a day for 14 days
|
|---|---|---|
|
Change From Baseline in Instantaneous Total Nasal Symptom Score for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined)
Baseline symptom score
|
17.63 scores on a scale
Standard Deviation 3.906
|
17.43 scores on a scale
Standard Deviation 3.665
|
|
Change From Baseline in Instantaneous Total Nasal Symptom Score for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined)
Overall change from baseline
|
-1.73 scores on a scale
Standard Deviation 3.669
|
-3.12 scores on a scale
Standard Deviation 4.099
|
SECONDARY outcome
Timeframe: baseline to14 Daysreflective and instantaneous symptom scores (itchy eyes, watery eyes and red eyes) 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 TOSS score is 9 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 |
Placebo
n=255 Participants
Placebo Nasal Spray/2 sprays per nostril once a day for 14 days
|
Astepro 0.15%
n=251 Participants
0.15% azelastine hydrochloride Nasal Spray/2 sprays per nostril once a day for 14 days
|
|---|---|---|
|
Change From Baseline in 12-hour Reflective Total Ocular Symptom Score and Instantaneous Total Ocular Symptom Score for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined)
Baseline: Reflective
|
11.85 Scores on a scale
Standard Deviation 4.580
|
11.52 Scores on a scale
Standard Deviation 4.273
|
|
Change From Baseline in 12-hour Reflective Total Ocular Symptom Score and Instantaneous Total Ocular Symptom Score for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined)
Change from Baseline: Reflective
|
-1.28 Scores on a scale
Standard Deviation 2.932
|
-2.21 Scores on a scale
Standard Deviation 3.419
|
|
Change From Baseline in 12-hour Reflective Total Ocular Symptom Score and Instantaneous Total Ocular Symptom Score for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined)
Baseline: Instantaneous
|
11.33 Scores on a scale
Standard Deviation 4.700
|
11.08 Scores on a scale
Standard Deviation 4.449
|
|
Change From Baseline in 12-hour Reflective Total Ocular Symptom Score and Instantaneous Total Ocular Symptom Score for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined)
Change from Baseline: Instantaneous
|
-1.05 Scores on a scale
Standard Deviation 2.913
|
-2.03 Scores on a scale
Standard Deviation 3.313
|
SECONDARY outcome
Timeframe: 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. Scores for a series of subsclaes 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=255 Participants
Placebo Nasal Spray/2 sprays per nostril once a day for 14 days
|
Astepro 0.15%
n=251 Participants
0.15% azelastine hydrochloride Nasal Spray/2 sprays per nostril once a day for 14 days
|
|---|---|---|
|
Change From Baseline to Visit 4 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Subjects 18 Years of Age and Older
Baseline:
|
4.39 Units on a Scale
Standard Deviation 1.149
|
4.33 Units on a Scale
Standard Deviation 1.226
|
|
Change From Baseline to Visit 4 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Subjects 18 Years of Age and Older
Change from Baseline:
|
-0.98 Units on a Scale
Standard Deviation 1.463
|
-1.33 Units on a Scale
Standard Deviation 1.599
|
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 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=255 Participants
Placebo Nasal Spray/2 sprays per nostril once a day for 14 days
|
Astepro 0.15%
n=251 Participants
0.15% azelastine hydrochloride Nasal Spray/2 sprays per nostril once a day for 14 days
|
|---|---|---|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Epistaxis: screening - None (n=255, 251)
|
255 Participants
|
249 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Epistaxis: screening - Mild (n=255, 251)
|
0 Participants
|
2 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Epistaxis: screening - Moderate (n=255, 251)
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Epistaxis: screening - Severe (n=255, 251)
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Epistaxis: Day 14/ET - None (n=255, 249)
|
254 Participants
|
246 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Epistaxis: Day 14/ET - Mild (n=255, 249)
|
1 Participants
|
3 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Epistaxis: Day 14/ET - Moderate (n=255, 249)
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Epistaxis: Day 14/ET - Severe (n=255, 249)
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Nasal Irritation: screening - None (n=255, 251)
|
236 Participants
|
231 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Nasal Irritation: screening -Grade 1A (n=255, 251
|
19 Participants
|
20 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Nasal Irritation: screening -Grade 1B (n=255, 251)
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Nasal Irritation: screening - Grade 2 (n=255, 251)
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Nasal Irritation: screening - Grade 3 (n=255, 251)
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Nasal Irritation: screening - Grade 4 (n=255, 251)
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Nasal Irritation: Day 14/ET - None(n=255, 249)
|
246 Participants
|
228 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Nasal Irritation: Day 14/ET- Grade 1A (n=255, 249)
|
8 Participants
|
19 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Nasal Irritation: Day 14/ET- Grade 1B (n=255, 249)
|
1 Participants
|
2 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Nasal Irritation: Day 14/ET- Grade 2 (n=255, 249)
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Nasal Irritation: Day 14/ET- Grade 3 (n=255, 249)
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Nasal Irritation: Day 14/ET- Grade 4 (n=255, 249)
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Mucosal Edema: screening - None (n=255, 251)
|
18 Participants
|
19 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Mucosal Edema: screening - Mild (n=255, 251)
|
54 Participants
|
58 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Mucosal Edema: screening - Moderate (n=255, 251)
|
155 Participants
|
129 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Mucosal Edema: screening - Severe (n=255, 251)
|
28 Participants
|
45 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Mucosal Edema: Day 14/ET - None (n=255, 249)
|
18 Participants
|
24 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Mucosal Edema: Day 14/ET - Mild (n=255, 249)
|
73 Participants
|
66 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Mucosal Edema: Day 14/ET - Moderate (n=255, 249)
|
131 Participants
|
123 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Mucosal Edema: Day 14/ET - Severe (n=255, 249)
|
33 Participants
|
36 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Nasal Discharge: screening - None (n=255, 251)
|
41 Participants
|
33 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Nasal Discharge: screening - Mild (n=255, 251)
|
102 Participants
|
108 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Nasal Discharge: screening - Moderate (n=255, 251)
|
97 Participants
|
89 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Nasal Discharge: screening - Severe (n=255, 251)
|
15 Participants
|
21 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Nasal Discharge: Day 14/ET - None (n=255, 249)
|
38 Participants
|
45 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Nasal Discharge: Day 14/ET- Mild (n=255, 249)
|
130 Participants
|
120 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Nasal Discharge: Day 14/ET - Moderate (n=255, 249)
|
80 Participants
|
67 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Nasal Discharge: Day 14/ET - Severe (n=255, 249)
|
7 Participants
|
17 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Mucosal Erythema: screening - None (n=255, 251)
|
153 Participants
|
139 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Mucosal Erythema: screening -Mild (n=255, 251)
|
49 Participants
|
60 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Mucosal Erythema: screening -Moderate (n=255, 251)
|
47 Participants
|
49 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Mucosal Erythema: screening -Severe (n=255, 251)
|
6 Participants
|
3 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Mucosal Erythema: Day 14/ET - None (n=255, 249)
|
153 Participants
|
145 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Mucosal Erythema: Day 14/ET - Mild (n=255, 249)
|
49 Participants
|
50 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Mucosal Erythema: Day 14/ET Moderate (n=255, 249)
|
43 Participants
|
36 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Mucosal Erythema: Day 14/ET Severe (n=255, 249)
|
10 Participants
|
18 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Mucosal Bleeding: screening - None (n=255, 251)
|
251 Participants
|
247 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Mucosal Bleeding: screening - Mild (n=255, 251)
|
4 Participants
|
3 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Mucosal Bleeding: screening Moderate (n=255, 251)
|
0 Participants
|
1 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Mucosal Bleeding: screening - Severe (n=255, 251)
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Mucosal Bleeding: Day 14/ET - None (n=255, 249)
|
254 Participants
|
243 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Mucosal Bleeding: Day 14/ET - Mild (n=255, 249)
|
1 Participants
|
6 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Mucosal Bleeding: Day 14/ET Moderate (n=255, 249)
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Mucosal Bleeding: Day 14/ET - Severe (n=255, 249)
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Crusting of Mucosa: screening - None (n=255, 251)
|
236 Participants
|
229 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Crusting of Mucosa: screening - Mild (n=255, 251)
|
17 Participants
|
19 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Crusting of Mucosascreening Moderate (n=255,251)
|
2 Participants
|
3 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Crusting of Mucosa: screening Severe (n=255, 251)
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Crusting of Mucosa: Day 14/ET - None (n=255, 249)
|
248 Participants
|
240 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Crusting of Mucosa: Day 14/ET - Mild (n=255, 249)
|
5 Participants
|
8 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Crusting of Mucosa:Day 14/ET Moderate (n=255, 249)
|
1 Participants
|
1 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams to 14 Days
Crusting of Mucosa:Day 14/ET Severe (n=255, 249)
|
1 Participants
|
0 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Astepro 0.15%
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=255 participants at risk
Placebo Nasal Spray/2 sprays per nostril once a day for 14 days
|
Astepro 0.15%
n=251 participants at risk
0.15% azelastine hydrochloride Nasal Spray/2 sprays per nostril once a day for 14 days
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.00%
0/255
|
3.6%
9/251 • Number of events 9
|
|
Nervous system disorders
Dysgeusia
|
0.78%
2/255 • Number of events 2
|
2.4%
6/251 • Number of events 6
|
|
Nervous system disorders
Headache
|
0.00%
0/255
|
2.0%
5/251 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/255
|
2.0%
5/251 • 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