Trial Outcomes & Findings for Study to Evaluate the Safety and Tolerability of a Nasal Spray in Patients With Chronic Allergic or Nonallergic Rhinitis (NCT NCT00783432)
NCT ID: NCT00783432
Last Updated: 2009-10-06
Results Overview
An AE can be any unfavorable and unintended sign,symptom, or disease temporally associated with the use of this investigational product, whether or not considered related to the investigational product. An AE is any untoward medical occurrence in a subject which does not necessarily have a causal relationship with this treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
862 participants
Primary outcome timeframe
12 months
Results posted on
2009-10-06
Participant Flow
First observation 24 July 2006 and last observation 28 Dec 2007
Subjects participated in a one-week screening period to identify appropriate subjects based on symptom scores
Participant milestones
| Measure |
Astepro Nasal Spray
(0.1% azelastine hydrochloride)
|
Astelin Nasal Spray
(0.1% azelastine hydrochloride)
|
|---|---|---|
|
Overall Study
STARTED
|
430
|
432
|
|
Overall Study
COMPLETED
|
345
|
354
|
|
Overall Study
NOT COMPLETED
|
85
|
78
|
Reasons for withdrawal
| Measure |
Astepro Nasal Spray
(0.1% azelastine hydrochloride)
|
Astelin Nasal Spray
(0.1% azelastine hydrochloride)
|
|---|---|---|
|
Overall Study
Adverse Event
|
22
|
17
|
|
Overall Study
Lack of Efficacy
|
20
|
21
|
|
Overall Study
Lost to Follow-up
|
11
|
6
|
|
Overall Study
Withdrawal by Subject
|
23
|
20
|
|
Overall Study
subject moved
|
3
|
5
|
|
Overall Study
Protocol Violation
|
6
|
9
|
Baseline Characteristics
Study to Evaluate the Safety and Tolerability of a Nasal Spray in Patients With Chronic Allergic or Nonallergic Rhinitis
Baseline characteristics by cohort
| Measure |
Astepro Nasal Spray
n=428 Participants
(0.1% azelastine hydrochloride)
|
Astelin Nasal Spray
n=430 Participants
(0.1% azelastine hydrochloride)
|
Total
n=858 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
389 Participants
n=5 Participants
|
391 Participants
n=7 Participants
|
780 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
28 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Age Continuous
|
41.2 years
STANDARD_DEVIATION 14.95 • n=5 Participants
|
41.3 years
STANDARD_DEVIATION 15.12 • n=7 Participants
|
41.2 years
STANDARD_DEVIATION 15.03 • n=5 Participants
|
|
Sex: Female, Male
Female
|
221 Participants
n=5 Participants
|
236 Participants
n=7 Participants
|
457 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
207 Participants
n=5 Participants
|
194 Participants
n=7 Participants
|
401 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
410 Participants
n=5 Participants
|
405 Participants
n=7 Participants
|
815 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
40 participants
n=5 Participants
|
39 participants
n=7 Participants
|
79 participants
n=5 Participants
|
|
Region of Enrollment
Europe
|
388 participants
n=5 Participants
|
391 participants
n=7 Participants
|
779 participants
n=5 Participants
|
|
Duration of Rhinitis
|
10.5 years
STANDARD_DEVIATION 11.04 • n=5 Participants
|
11.3 years
STANDARD_DEVIATION 10.85 • n=7 Participants
|
10.9 years
STANDARD_DEVIATION 10.95 • n=5 Participants
|
|
Total Nasal Symptom Score (AM + PM)
|
9.69 units on a scale (0-3)
STANDARD_DEVIATION 4.506 • n=5 Participants
|
9.96 units on a scale (0-3)
STANDARD_DEVIATION 4.725 • n=7 Participants
|
9.82 units on a scale (0-3)
STANDARD_DEVIATION 4.617 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Number of participants for analysis was based on a safety population that included any subject who received at least one dose of study medication.
An AE can be any unfavorable and unintended sign,symptom, or disease temporally associated with the use of this investigational product, whether or not considered related to the investigational product. An AE is any untoward medical occurrence in a subject which does not necessarily have a causal relationship with this treatment.
Outcome measures
| Measure |
Astepro Nasal Spray
n=428 Participants
(0.1% azelastine hydrochloride)
|
Astelin Nasal Spray
n=430 Participants
(0.1% azelastine hydrochloride)
|
|---|---|---|
|
Number of Participants Reporting Adverse Events
|
207 Participants
|
211 Participants
|
PRIMARY outcome
Timeframe: baseline and 12 months/ETExamination of head and neck(scale: 0, 1+=Mild, 2+=Moderate, 3++Severe) for mucosal edema, nasal discharge, mucosal erythema, mucosal bleeding, mucosal ulcerations, crusting of mucosa, conjunctiva, tympanic membranes, lymph nodes of head and neck. Direct visual nasal examination (scale: None, Grade 2, Grade 3, and Grade 4) for epistaxis,ulceration and pain.
Outcome measures
| Measure |
Astepro Nasal Spray
n=428 Participants
(0.1% azelastine hydrochloride)
|
Astelin Nasal Spray
n=430 Participants
(0.1% azelastine hydrochloride)
|
|---|---|---|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Tympanic membranes: baseline-Mild (1+)
|
60 Participants
|
62 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Tympanic membranes:baselineModerate (2+)
|
21 Participants
|
17 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Tympanic membranes: M12/ET-Moderate (2+)
|
1 Participants
|
4 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Lymphadenopathy: M12/ET-None
|
408 Participants
|
407 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Lymphadenopathy:M12/ET-Mild (1+)
|
6 Participants
|
10 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Lymphadenopathy: M12/ET-Severe (3+)
|
0 Participants
|
0 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Mucosal edema:M12/ET-None
|
160 Participants
|
147 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Nasal discharge: baseline-None
|
40 Participants
|
44 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Nasal discharge: baseline-Mild (1+)
|
113 Participants
|
109 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Mucosal erythema: M12/ET-None
|
213 Participants
|
221 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Mucosal erythema: M12/ET-Mild (1+)
|
152 Participants
|
153 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Mucosal erythema: M12/ET-Moderate (2+)
|
45 Participants
|
35 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Mucosal bleeding: M12/ET-Severe (3+)
|
0 Participants
|
0 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Mucosal ulcerations: Total baseline
|
428 Participants
|
430 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Mucosal ulcerations: baseline-Moderate (2+)
|
26 Participants
|
25 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Mucosal ulcerations: baseline-Severe (3+)
|
6 Participants
|
6 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Mucosal ulcerations: Total M12/ET
|
414 Participants
|
417 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Crusting of mucosa: Total M12/ET
|
414 Participants
|
417 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Crusting of mucosa: M12/ET-None
|
387 Participants
|
382 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Epistaxis: Total baseline
|
428 Participants
|
430 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Epistaxis: baseline None
|
402 Participants
|
416 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Epistaxis: baseline Grade 3
|
0 Participants
|
1 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Epistaxis: baseline Grade 4
|
0 Participants
|
1 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Epistaxis: M12/ET None
|
413 Participants
|
415 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Epistaxis: M12/ETGrade 2
|
1 Participants
|
2 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Epistaxis:M12/ET Grade 3
|
0 Participants
|
0 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Ulceration: Total baseline
|
428 Participants
|
430 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Ulceration: baseline None
|
365 Participants
|
373 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Pain: Total baseline
|
428 Participants
|
430 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Pain: baseline None
|
377 Participants
|
382 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Pain: baseline Grade 2
|
38 Participants
|
28 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Pain: baseline Grade 3
|
6 Participants
|
17 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Pain: baseline Grade 4
|
7 Participants
|
3 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Nasal discharge:M12/ET-Severe (3+)
|
2 Participants
|
7 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Mucosal erythema: Total baseline
|
428 Participants
|
430 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Conjunctiva: Total baseline
|
428 Participants
|
430 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Conjunctiva: baseline-None
|
264 Participants
|
254 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Conjunctiva: baseline-Mild (1+)
|
99 Participants
|
109 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Conjunctiva: baseline-Moderate (2+)
|
53 Participants
|
54 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Conjunctiva: baseline-Severe (3+)
|
12 Participants
|
13 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Conjunctiva: Total M12/ET
|
414 Participants
|
417 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Conjunctiva: M12/ET-None
|
366 Participants
|
363 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Conjunctiva: M12/ET-Mild (1+)
|
44 Participants
|
43 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Conjunctiva: M12/ET-Moderate (2+)
|
4 Participants
|
11 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Conjunctiva:M12/ET-Severe (3+)
|
0 Participants
|
0 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Tympanic membranes: Total baseline
|
428 Participants
|
430 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Tympanic membranes: baseline-None
|
342 Participants
|
344 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Tympanic membranes: baseline-Severe (3+)
|
5 Participants
|
7 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Tympanic membranes: Total M12/ET
|
414 Participants
|
417 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Tympanic membranes: M12/ET-None
|
405 Participants
|
408 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Tympanic membranes:M12/ET-Mild (1+)
|
8 Participants
|
5 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Tympanic membranes:M12/ET Severe (3+)
|
0 Participants
|
0 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Lymphadenopathy: Total baseline
|
428 Participants
|
430 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Lymphadenopathy: baseline-None
|
389 Participants
|
393 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Lymphadenopathy: baseline-Mild (1+)
|
32 Participants
|
27 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Lymphadenopathy: baseline-Moderate (2+)
|
7 Participants
|
7 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Lymphadenopathy: baseline-Severe (3+)
|
0 Participants
|
3 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Lymphadenopathy: Total M12/ET
|
414 Participants
|
417 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Lymphadenopathy:M12/ET-Moderate (2+)
|
0 Participants
|
0 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Mucosal edema: Total baseline
|
428 Participants
|
430 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Mucosal edema: baseline-None
|
32 Participants
|
30 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Mucosal edema: baseline-Mild (1+)
|
91 Participants
|
80 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Mucosal edema: baseline-Moderate (2+)
|
191 Participants
|
200 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Mucosal edema: baseline-Severe (3+)
|
114 Participants
|
120 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Mucosal edema: Total M12/ET
|
414 Participants
|
417 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Mucosal edema: M12/ET-Mild (1+)
|
176 Participants
|
182 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Mucosal edema: M12/ET-Moderate (2+)
|
69 Participants
|
76 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Mucosal edema: M12/ET-Severe (3+)
|
9 Participants
|
12 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Nasal discharge: Total baseline
|
428 Participants
|
430 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Nasal discharge: baseline-Moderate (2+)
|
179 Participants
|
183 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Nasal discharge: baseline-Severe (3+)
|
96 Participants
|
94 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Nasal discharge: Total M12/ET
|
414 Participants
|
417 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Nasal discharge:M12/ET-None
|
178 Participants
|
173 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Nasal discharge: M12/ET-Mild (1+)
|
188 Participants
|
183 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Nasal discharge: M12/ET-Moderate (2+)
|
46 Participants
|
54 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Mucosal erythema: baseline-None
|
80 Participants
|
82 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Mucosal erythema: baseline-Mild (1+)
|
120 Participants
|
112 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Mucosal erythema: baseline-Monderate (2+)
|
171 Participants
|
178 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Mucosal erythema: baseline-Severe (3+)
|
57 Participants
|
58 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Mucosal erythema: Total M12/ET
|
414 Participants
|
417 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Mucosal erythema:M12/ET-Severe (3+)
|
4 Participants
|
8 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Mucosal bleeding: Total baseline
|
428 Participants
|
430 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Mucosal bleeding: baseline-None
|
362 Participants
|
376 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Mucosal bleeding: baseline-Mild (1+)
|
56 Participants
|
51 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Mucosal bleeding: baseline-Moderate (2+)
|
10 Participants
|
2 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Mucosal bleeding: baseline-Severe (3+)
|
0 Participants
|
1 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Mucosal bleeding: Total M12/ET
|
414 Participants
|
417 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Mucosal bleeding: M12/ET-None
|
402 Participants
|
403 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Mucosal bleeding: M12/ET-Mild (1+)
|
11 Participants
|
10 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Mucosal bleeding: M12/ET-Moderate (2+)
|
1 Participants
|
4 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Mucosal ulcerations: baseline-None
|
348 Participants
|
362 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Mucosal ulcerations: baseline-Mild (1+)
|
48 Participants
|
37 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Mucosal ulcerations: M12/ET-None
|
401 Participants
|
404 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Mucosal ulcerations: M12/ET-Mild (1+)
|
11 Participants
|
10 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Mucosal ulcerations: M12/ET-Moderate (2+)
|
2 Participants
|
3 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Mucosal ulcerations: M12/ET-Severe (3+)
|
0 Participants
|
0 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Crusting of mucosa: Total baseline
|
428 Participants
|
430 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Crusting of mucosa: baseline-None
|
293 Participants
|
311 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Crusting of mucosa: baseline-Mild (1+)
|
86 Participants
|
75 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Crusting of mucosa: baseline-Moderate (2+)
|
36 Participants
|
35 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Crusting of mucosa: baseline-Severe (3+)
|
13 Participants
|
9 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Crusting of mucosa: M12/ET-Mild (1+)
|
24 Participants
|
32 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Crusting of mucosa: M12/ET-Moderate (2+)
|
3 Participants
|
3 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Crusting of mucosa:M12/ET-Severe (3+)
|
0 Participants
|
0 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Epistaxis: baseline Grade 2
|
26 Participants
|
12 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Epistaxis:Total M12/ET
|
414 Participants
|
417 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Epistaxis: M12/ETGrade 4
|
0 Participants
|
0 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Ulceration: baseline Grade 2
|
63 Participants
|
57 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Ulceration: baseline Grade 3
|
0 Participants
|
0 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Ulceration: baseline Grade 4
|
0 Participants
|
0 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Ulceration: Total M12/ET
|
413 Participants
|
417 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Ulceration:M12/ET None
|
404 Participants
|
411 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Ulceration: M12/ET Grade 2
|
8 Participants
|
6 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Ulceration: M12/ET Grade 3
|
1 Participants
|
0 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Ulceration: M12/ET Grade 4
|
0 Participants
|
0 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Pain: Total M12/ET
|
413 Participants
|
417 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Pain: M12/ET None
|
401 Participants
|
409 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Pain: M12/ET Grade 2
|
10 Participants
|
6 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Pain: M12/ET Grade 3
|
2 Participants
|
2 Participants
|
|
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Pain: M12/ET Grade 4
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: baseline, months 1,3,6,9 and 12/or early terminationPopulation: Analysis is based on safety population, which is defined as subjects who took at least one dose of study medication.
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. Total possible RQLQ score is 42 at any given evaluation. Scale of how troubled is:0=Not,2=Somewhat,3=Moderate,4=Quite a bit,5=Very,6 Extremely. Only change from baseline to month 12 primary analysis is provided.
Outcome measures
| Measure |
Astepro Nasal Spray
n=428 Participants
(0.1% azelastine hydrochloride)
|
Astelin Nasal Spray
n=430 Participants
(0.1% azelastine hydrochloride)
|
|---|---|---|
|
Adult Mini-Rhinoconjuctivitis Quality of Life Questionnaire. Change From Baseline in RQLQ Score at Months 1,3,6,9 and 12/or Early Termination.
Baseline
|
2.25 Units on a scale
Standard Deviation 1.103
|
2.18 Units on a scale
Standard Deviation 1.050
|
|
Adult Mini-Rhinoconjuctivitis Quality of Life Questionnaire. Change From Baseline in RQLQ Score at Months 1,3,6,9 and 12/or Early Termination.
Month 1
|
-0.77 Units on a scale
Standard Deviation 1.007
|
-0.83 Units on a scale
Standard Deviation 0.959
|
|
Adult Mini-Rhinoconjuctivitis Quality of Life Questionnaire. Change From Baseline in RQLQ Score at Months 1,3,6,9 and 12/or Early Termination.
Month 9
|
-1.09 Units on a scale
Standard Deviation 1.228
|
-1.16 Units on a scale
Standard Deviation 1.197
|
|
Adult Mini-Rhinoconjuctivitis Quality of Life Questionnaire. Change From Baseline in RQLQ Score at Months 1,3,6,9 and 12/or Early Termination.
Month 12/Early termination
|
-0.88 Units on a scale
Standard Deviation 1.385
|
-0.90 Units on a scale
Standard Deviation 1.339
|
|
Adult Mini-Rhinoconjuctivitis Quality of Life Questionnaire. Change From Baseline in RQLQ Score at Months 1,3,6,9 and 12/or Early Termination.
Month 3
|
-1.00 Units on a scale
Standard Deviation 1.063
|
-1.00 Units on a scale
Standard Deviation 1.048
|
|
Adult Mini-Rhinoconjuctivitis Quality of Life Questionnaire. Change From Baseline in RQLQ Score at Months 1,3,6,9 and 12/or Early Termination.
Month 6
|
-1.04 Units on a scale
Standard Deviation 1.206
|
-0.94 Units on a scale
Standard Deviation 1.230
|
Adverse Events
Astepro Nasal Spray
Serious events: 7 serious events
Other events: 163 other events
Deaths: 0 deaths
Astelin Nasal Spray
Serious events: 10 serious events
Other events: 146 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Astepro Nasal Spray
(0.1% azelastine hydrochloride)
|
Astelin Nasal Spray
(0.1% azelastine hydrochloride)
|
|---|---|---|
|
Cardiac disorders
Battery change for internal cardiac defibrillator
|
0.23%
1/428 • Number of events 1
|
0.00%
0/430
|
|
Infections and infestations
Sialoadenitis
|
0.23%
1/428 • Number of events 1
|
0.00%
0/430
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.23%
1/428 • Number of events 1
|
0.00%
0/430
|
|
Infections and infestations
Acute Pyelonephritis
|
0.23%
1/428 • Number of events 1
|
0.00%
0/430
|
|
Injury, poisoning and procedural complications
Knee traumatism
|
0.23%
1/428 • Number of events 1
|
0.00%
0/430
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Carcinoma
|
0.23%
1/428 • Number of events 1
|
0.00%
0/430
|
|
Cardiac disorders
Exacerbation angina pectoris
|
0.23%
1/428 • Number of events 1
|
0.00%
0/430
|
|
Cardiac disorders
Central Chest Pain
|
0.23%
1/428 • Number of events 1
|
0.00%
0/430
|
|
Musculoskeletal and connective tissue disorders
Exacerbation right shoulder pain
|
0.23%
1/428 • Number of events 1
|
0.00%
0/430
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.23%
1/428 • Number of events 1
|
0.00%
0/430
|
|
Renal and urinary disorders
Removal of bladder stones
|
0.00%
0/428
|
0.23%
1/430 • Number of events 1
|
|
Reproductive system and breast disorders
Ovarian Cyst
|
0.00%
0/428
|
0.23%
1/430 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Exertional dyspnoea
|
0.00%
0/428
|
0.23%
1/430 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/428
|
0.23%
1/430 • Number of events 1
|
|
Infections and infestations
Pneumonia Chlamidalis
|
0.00%
0/428
|
0.23%
1/430 • Number of events 1
|
|
Pregnancy, puerperium and perinatal conditions
Spontaneous Abortion
|
0.00%
0/428
|
0.23%
1/430 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fracture left foot
|
0.00%
0/428
|
0.23%
1/430 • Number of events 1
|
|
Injury, poisoning and procedural complications
Broken nose
|
0.00%
0/428
|
0.23%
1/430 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.00%
0/428
|
0.23%
1/430 • Number of events 1
|
|
Gastrointestinal disorders
Upper Abdominal Colic
|
0.00%
0/428
|
0.23%
1/430 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Total right hip replacement
|
0.00%
0/428
|
0.23%
1/430 • Number of events 1
|
Other adverse events
| Measure |
Astepro Nasal Spray
(0.1% azelastine hydrochloride)
|
Astelin Nasal Spray
(0.1% azelastine hydrochloride)
|
|---|---|---|
|
Nervous system disorders
Headache
|
11.4%
49/428 • Number of events 49
|
10.0%
43/430 • Number of events 43
|
|
Infections and infestations
Nasopharyngitis
|
7.9%
34/428 • Number of events 34
|
5.8%
25/430 • Number of events 25
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.8%
29/428 • Number of events 29
|
7.4%
32/430 • Number of events 32
|
|
Nervous system disorders
Dysgeusia
|
6.5%
28/428 • Number of events 28
|
7.4%
32/430 • Number of events 32
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
5.4%
23/428 • Number of events 23
|
3.3%
14/430 • Number of events 14
|
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