Trial Outcomes & Findings for A Study to Evaluate the Safety & Effectiveness of a Nasal Spray to Treat Seasonal Allergies (NCT NCT00719862)
NCT ID: NCT00719862
Last Updated: 2010-02-02
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 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
481 participants
Primary outcome timeframe
baseline and 14 days
Results posted on
2010-02-02
Participant Flow
First observation: August 20, 2007 Last observation: November 14, 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 once daily for 14 days
|
Astepro 0.15%
0.15% azelastine hydrochloride Nasal Spray/2sprays per nostril once daily for 14 days
|
|---|---|---|
|
Overall Study
STARTED
|
242
|
239
|
|
Overall Study
COMPLETED
|
234
|
233
|
|
Overall Study
NOT COMPLETED
|
8
|
6
|
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/2sprays per nostril once daily for 14 days
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Lack of Efficacy
|
3
|
0
|
|
Overall Study
Non-Compliance
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Other
|
2
|
3
|
Baseline Characteristics
A Study to Evaluate the Safety & Effectiveness of a Nasal Spray to Treat Seasonal Allergies
Baseline characteristics by cohort
| Measure |
Placebo
n=242 Participants
Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
|
Astepro 0.15%
n=238 Participants
0.15% azelastine hydrochloride Nasal Spray/2sprays per nostril once daily for 14 days
|
Total
n=480 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
29 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
205 Participants
n=5 Participants
|
213 Participants
n=7 Participants
|
418 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age Continuous
|
35.3 years
STANDARD_DEVIATION 13.91 • n=5 Participants
|
35.5 years
STANDARD_DEVIATION 13.53 • n=7 Participants
|
35.4 years
STANDARD_DEVIATION 13.71 • n=5 Participants
|
|
Sex: Female, Male
Female
|
162 Participants
n=5 Participants
|
154 Participants
n=7 Participants
|
316 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
80 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
164 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
242 participants
n=5 Participants
|
238 participants
n=7 Participants
|
480 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 14 daysreflective 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=242 Participants
Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
|
Astepro 0.15%
n=238 Participants
0.15% azelastine hydrochloride Nasal Spray/2sprays per nostril once daily for 14 days
|
|---|---|---|
|
Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined)at 14 Days
Baseline symptom score
|
17.72 scores on a scale
Standard Deviation 3.310
|
17.74 scores on a scale
Standard Deviation 3.540
|
|
Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined)at 14 Days
Overall change from baseline
|
-2.55 scores on a scale
Standard Deviation 4.195
|
-3.60 scores on a scale
Standard Deviation 4.469
|
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. 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=242 Participants
Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
|
Astepro 0.15%
n=238 Participants
0.15% azelastine hydrochloride Nasal Spray/2sprays per nostril once daily for 14 days
|
|---|---|---|
|
Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (tNSS) (AM) for the Entire 14-day Study Period Compared to Placebo
|
-1.05 scores on a scale
Standard Deviation 2.059
|
-1.35 scores on a scale
Standard Deviation 2.320
|
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 |
Placebo
n=242 Participants
Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
|
Astepro 0.15%
n=238 Participants
0.15% azelastine hydrochloride Nasal Spray/2sprays per nostril once daily for 14 days
|
|---|---|---|
|
Change From Baseline in 12 Hour Instantaneous Total Nasal Sytmptom Score (AM and PM Combined)at 14 Days
Baseline symptom score
|
16.39 total nasal symptom score
Standard Deviation 3.936
|
16.23 total nasal symptom score
Standard Deviation 4.528
|
|
Change From Baseline in 12 Hour Instantaneous Total Nasal Sytmptom Score (AM and PM Combined)at 14 Days
Overall change from baseline
|
-2.16 total nasal symptom score
Standard Deviation 4.141
|
-3.03 total nasal symptom score
Standard Deviation 4.518
|
SECONDARY outcome
Timeframe: baseline and 14-daysReflective secondary symptom 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. 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=242 Participants
Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
|
Astepro 0.15%
n=238 Participants
0.15% azelastine hydrochloride Nasal Spray/2sprays per nostril once daily for 14 days
|
|---|---|---|
|
Change From Baseline in 12-hour Reflective SSCS for the Entire 14-day Study Period Compared to Placebo (Am and PM Combined)
Baseline SSCS
|
13.55 Refecltive secondary symptom score
Standard Deviation 5.024
|
13.03 Refecltive secondary symptom score
Standard Deviation 5.408
|
|
Change From Baseline in 12-hour Reflective SSCS for the Entire 14-day Study Period Compared to Placebo (Am and PM Combined)
Change in baseline to Day 14
|
-1.72 Refecltive secondary symptom score
Standard Deviation 3.728
|
-2.46 Refecltive secondary symptom score
Standard Deviation 3.877
|
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. Total overall score is not calculated by adding all subscales scores for an overall score. 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=242 Participants
Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
|
Astepro 0.15%
n=238 Participants
0.15% azelastine hydrochloride Nasal Spray/2sprays per nostril once daily for 14 days
|
|---|---|---|
|
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at 14 Days
Baseline: Overall
|
3.51 Units on a scale
Standard Deviation 0.996
|
3.42 Units on a scale
Standard Deviation 1.101
|
|
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at 14 Days
Change from Baseline:Overall
|
-0.71 Units on a scale
Standard Deviation 1.172
|
-0.92 Units on a scale
Standard Deviation 1.058
|
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=242 Participants
Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
|
Astepro 0.15%
n=238 Participants
0.15% azelastine hydrochloride Nasal Spray/2sprays per nostril once daily for 14 days
|
|---|---|---|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Crusting of Mucosa: screening - Mild (n= 242, 239)
|
22 Participants
|
23 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Epistaxis: screening - None (n = 242, 239)
|
239 Participants
|
234 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Epistaxis: screening - Mild (n = 242, 239)
|
3 Participants
|
5 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Epistaxis: screening - Moderate (n = 242, 239)
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Epistaxis: screening - Severe (n = 242, 239)
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Epistaxis: Day 14/ET - None (n = 241, 237)
|
235 Participants
|
233 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Epistaxis: Day 14/ET - Mild (n = 241, 237)
|
6 Participants
|
4 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Epistaxis: Day 14/ET - Moderate (n = 241, 237)
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Epistaxis: Day 14/ET - Severe (n = 241, 237)
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Irritation: screening - None (n = 242, 239)
|
230 Participants
|
223 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Irritation: screening - Grade 1A (n = 242, 239)
|
11 Participants
|
16 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Irritation: screening - Grade 1B (n = 242, 239)
|
1 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Irritation: screening - Grade 2 (n = 242, 239)
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Irritation: screening - Grade 3 (n = 242, 239)
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Irritation: screening - Grade 4 (n = 242, 239)
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Irritation: Day 14/ET - None (n = 241, 237)
|
227 Participants
|
218 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Irritation: Day 14/ET - Grade 1A (n = 241, 237)
|
13 Participants
|
17 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Irritation: Day 14/ET - Grade 1B (n = 241, 237)
|
1 Participants
|
2 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Irritation: Day 14/ET - Grade 2 (n = 241, 237)
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Irritation: Day 14/ET - Grade 3 (n = 241, 237)
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Irritation: Day 14/ET - Grade 4 (n = 241, 237)
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Mucosal Edema: screening - None (n =242, 239)
|
27 Participants
|
27 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Mucosal Edema: screening - Mild (n =242, 239)
|
65 Participants
|
67 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Mucosal Edema: screening - Moderate (n =242, 239)
|
109 Participants
|
104 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Mucosal Edema: screening - Severe (n =242, 239)
|
41 Participants
|
41 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Mucosal Edema: Day 14/ET - None (n = 241, 236)
|
40 Participants
|
31 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Mucosal Edema: Day 14/ET - Mild (n = 241, 236)
|
102 Participants
|
102 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Mucosal Edema: Day 14/ET - Moderate (n = 241, 236)
|
76 Participants
|
77 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Mucosal Edema: Day 14/ET - Severe (n = 241, 236)
|
23 Participants
|
26 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Nasal Discharge: screening - None (n= 242, 239)
|
26 Participants
|
50 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Nasal Discharge: screening - Mild (n= 242, 239)
|
120 Participants
|
106 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Nasal Discharge: screening - Moderate (n= 242, 239
|
76 Participants
|
71 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Nasal Discharge: screening - Severe (n= 242, 239)
|
10 Participants
|
12 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Nasal Discharge: Day 14/ET - None (n= 241, 237)
|
81 Participants
|
70 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Nasal Discharge: Day 14/ET - Mild (n= 241, 237)
|
119 Participants
|
121 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Nasal Discharge: Day 14/ET - Moderate (n= 241, 23
|
40 Participants
|
39 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Nasal Discharge: Day 14/ET - Severe (n= 241, 237)
|
1 Participants
|
7 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Mucosal Erythema: screening - None (n= 242, 239)
|
124 Participants
|
113 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Mucosal Erythema: screening - Mild (n= 242, 239)
|
74 Participants
|
73 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Mucosal Erythema: screening - Moderate (n= 242,
|
39 Participants
|
51 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Mucosal Erythema: screening - Severe (n= 242, 239
|
5 Participants
|
2 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Mucosal Erythema: Day 14/ET - None (n= 241, 237)
|
146 Participants
|
142 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Mucosal Erythema: Day 14/ET - Mild (n= 241, 237)
|
64 Participants
|
58 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Mucosal Erythema: Day 14/ET - Moderate (n= 241, 23
|
28 Participants
|
33 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Mucosal Erythema: Day 14/ET - Severe (n= 241, 237)
|
3 Participants
|
4 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Mucosal Bleeding: screening - None (n= 242, 239)
|
237 Participants
|
233 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Mucosal Bleeding: screening - Mild (n= 242, 239)
|
4 Participants
|
6 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Mucosal Bleeding: screening - Moderate (n= 242, 23
|
1 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Mucosal Bleeding: screening - Severe (n= 242, 239)
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Mucosal Bleeding: Day 14/ET - None (n= 241, 237)
|
234 Participants
|
233 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Mucosal Bleeding: Day 14/ET - Mild (n= 241, 237)
|
7 Participants
|
4 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Mucosal Bleeding: Day 14/ET - Moderate (n= 241, 23
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Mucosal Bleeding: Day 14/ET - Severe (n= 241, 237)
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Crusting of Mucosa: screening - None (n= 242, 239)
|
218 Participants
|
214 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Crusting of Mucosa:screening Moderate (n= 242,239)
|
2 Participants
|
2 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Crusting of Mucosa: screening Severe (n= 242, 239)
|
0 Participants
|
0 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Crusting of Mucosa: Day 14/ET - None (n= 241, 237)
|
231 Participants
|
221 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Crusting of Mucosa: Day 14/ET - Mild (n= 241, 237)
|
8 Participants
|
12 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Crusting of Mucosa: Day14/ETModerate (n= 241,237)
|
2 Participants
|
4 Participants
|
|
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Crusting of Mucosa: Day 14/ET Severe (n= 241, 237)
|
0 Participants
|
0 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Astepro 0.15%
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=242 participants at risk
Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
|
Astepro 0.15%
n=238 participants at risk
0.15% azelastine hydrochloride Nasal Spray/2sprays per nostril once daily for 14 days
|
|---|---|---|
|
Nervous system disorders
Dysgusia
|
0.83%
2/242 • Number of events 2
|
3.4%
8/238 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Discomfort
|
1.7%
4/242 • Number of events 4
|
2.5%
6/238 • Number of events 6
|
|
Nervous system disorders
Headache
|
2.1%
5/242 • Number of events 5
|
1.3%
3/238 • Number of events 3
|
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