Trial Outcomes & Findings for Safety of Astepro 0.15% Nasal Spray and Astepro 0.1% Nasal Spray in Children Ages >6 Months to <6 Years With AR (NCT NCT01880840)
NCT ID: NCT01880840
Last Updated: 2015-06-29
Results Overview
The objective of this clinical trial is to evaluate the safety of Astepro 0.15% Nasal Spray and Astepro 0.1% Nasal Spray at a dosage of 1 spray per nostril twice daily in subjects ≥6months to \<6 years of age with allergic rhinitis. Safety will be assessed on the basis of reported adverse experiences, nasal examinations, laboratory evaluations, and vital signs assessments. Data for each age strata will be summarized separately as well as combined.
COMPLETED
PHASE4
191 participants
one month of treatment
2015-06-29
Participant Flow
Participant milestones
| Measure |
Astepro 0.15%
azelastine hydrochloride 822mcg nasal spray
|
Astepro 0.1%
azelastine hydrochloride 548 mcg nasal spray
|
|---|---|---|
|
Overall Study
STARTED
|
95
|
96
|
|
Overall Study
COMPLETED
|
87
|
91
|
|
Overall Study
NOT COMPLETED
|
8
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety of Astepro 0.15% Nasal Spray and Astepro 0.1% Nasal Spray in Children Ages >6 Months to <6 Years With AR
Baseline characteristics by cohort
| Measure |
Astepro 0.15% Nasal Spray
n=95 Participants
Nasal Spray at a dosage of 1 spray per nostril twice daily
205.5 mcg of azelastine hydrochloride: nasal spray
|
Astepro 0.1% Nasal Spray
n=96 Participants
Nasal Spray at a dosage of 1 spray per nostril twice daily
137 mcg of azelastine hydrochloride: nasal spray
|
Total
n=191 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
95 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
191 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
3.29 years
STANDARD_DEVIATION 1.538 • n=5 Participants
|
3.37 years
STANDARD_DEVIATION 1.595 • n=7 Participants
|
3.33 years
STANDARD_DEVIATION 1.566 • n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
95 participants
n=5 Participants
|
96 participants
n=7 Participants
|
191 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: one month of treatmentThe objective of this clinical trial is to evaluate the safety of Astepro 0.15% Nasal Spray and Astepro 0.1% Nasal Spray at a dosage of 1 spray per nostril twice daily in subjects ≥6months to \<6 years of age with allergic rhinitis. Safety will be assessed on the basis of reported adverse experiences, nasal examinations, laboratory evaluations, and vital signs assessments. Data for each age strata will be summarized separately as well as combined.
Outcome measures
| Measure |
Astepro 0.15% Nasal Spray
n=95 Participants
Nasal Spray at a dosage of 1 spray per nostril twice daily
205.5 mcg of azelastine hydrochloride: nasal spray
|
Astepro 0.1% Nasal Spray
n=96 Participants
Nasal Spray at a dosage of 1 spray per nostril twice daily
137 mcg of azelastine hydrochloride: nasal spray
|
|---|---|---|
|
Safety
|
43 adverse events
|
39 adverse events
|
Adverse Events
Astepro 0.15% Nasal Spray
Astepro 0.1% Nasal Spray
Serious adverse events
| Measure |
Astepro 0.15% Nasal Spray
n=95 participants at risk
Nasal Spray at a dosage of 1 spray per nostril twice daily
205.5 mcg of azelastine hydrochloride: nasal spray
|
Astepro 0.1% Nasal Spray
n=96 participants at risk
Nasal Spray at a dosage of 1 spray per nostril twice daily
137 mcg of azelastine hydrochloride: nasal spray
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
exacerbation of asthma
|
1.1%
1/95 • Number of events 1
|
0.00%
0/96
|
Other adverse events
| Measure |
Astepro 0.15% Nasal Spray
n=95 participants at risk
Nasal Spray at a dosage of 1 spray per nostril twice daily
205.5 mcg of azelastine hydrochloride: nasal spray
|
Astepro 0.1% Nasal Spray
n=96 participants at risk
Nasal Spray at a dosage of 1 spray per nostril twice daily
137 mcg of azelastine hydrochloride: nasal spray
|
|---|---|---|
|
General disorders
pyrexia
|
6.3%
6/95
|
5.2%
5/96
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
3.2%
3/95
|
1.0%
1/96
|
|
Respiratory, thoracic and mediastinal disorders
epistaxis
|
3.2%
3/95
|
0.00%
0/96
|
|
Respiratory, thoracic and mediastinal disorders
sneezing
|
3.2%
3/95
|
0.00%
0/96
|
|
Gastrointestinal disorders
dysgusia
|
2.1%
2/95
|
0.00%
0/96
|
|
Respiratory, thoracic and mediastinal disorders
rhinalgia
|
2.1%
2/95
|
0.00%
0/96
|
|
Infections and infestations
upper respiratory tract infection
|
2.1%
2/95
|
1.0%
1/96
|
|
Gastrointestinal disorders
vomiting
|
2.1%
2/95
|
1.0%
1/96
|
|
Ear and labyrinth disorders
otitis media
|
0.00%
0/95
|
3.1%
3/96
|
|
Skin and subcutaneous tissue disorders
dermatitis,contact
|
0.00%
0/95
|
2.1%
2/96
|
|
General disorders
oropharyngial pain
|
0.00%
0/95
|
2.1%
2/96
|
Additional Information
Dr.Nancy Ruiz Chief Medical Officer
Meda Pharmaceutical
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place