Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of a Nasal Spray to Treat Children With Perennial Allergic Rhinitis (NCT NCT01018862)
NCT ID: NCT01018862
Last Updated: 2012-06-11
Results Overview
Change from baseline in 12-hour reflective total nasal symptom score (TNSS) for the entire 28-day study period compared to placebo,scored on a 0 to 24 scale with 0 being no symptoms and 24 being severe symptoms.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
489 participants
Primary outcome timeframe
baseline to 28 Days
Results posted on
2012-06-11
Participant Flow
Participant milestones
| Measure |
MP03-36 (0.15% Solution)
822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
|
MP03-33 (0.10% Solution)
548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
|
Placebo
0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
161
|
166
|
162
|
|
Overall Study
COMPLETED
|
148
|
156
|
146
|
|
Overall Study
NOT COMPLETED
|
13
|
10
|
16
|
Reasons for withdrawal
| Measure |
MP03-36 (0.15% Solution)
822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
|
MP03-33 (0.10% Solution)
548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
|
Placebo
0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
6
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
3
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
1
|
|
Overall Study
administrative problems
|
5
|
4
|
4
|
Baseline Characteristics
A Study to Evaluate the Safety and Efficacy of a Nasal Spray to Treat Children With Perennial Allergic Rhinitis
Baseline characteristics by cohort
| Measure |
MP03-36 (0.15% Solution)
n=161 Participants
822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
|
MP03-33 (0.10% Solution)
n=166 Participants
548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
|
Placebo
n=162 Participants
0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
|
Total
n=489 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
161 Participants
n=5 Participants
|
166 Participants
n=7 Participants
|
162 Participants
n=5 Participants
|
489 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age Continuous
|
8.8 years
STANDARD_DEVIATION 2.6 • n=5 Participants
|
8.8 years
STANDARD_DEVIATION 2.7 • n=7 Participants
|
8.7 years
STANDARD_DEVIATION 2.8 • n=5 Participants
|
8.8 years
STANDARD_DEVIATION 2.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
208 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
87 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
281 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
161 participants
n=5 Participants
|
166 participants
n=7 Participants
|
162 participants
n=5 Participants
|
489 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: baseline to 28 DaysPopulation: participant must have had at least one post baseline efficacy assessment
Change from baseline in 12-hour reflective total nasal symptom score (TNSS) for the entire 28-day study period compared to placebo,scored on a 0 to 24 scale with 0 being no symptoms and 24 being severe symptoms.
Outcome measures
| Measure |
MP03-36 (0.15% Solution)
n=159 Participants
822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
|
MP03-33 (0.10% Solution)
n=166 Participants
548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
|
Placebo
n=161 Participants
0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
|
|---|---|---|---|
|
Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (TNSS) for the Entire 28-day Study Period Compared to Placebo
|
-3.45 units on a scale
Standard Deviation 4.03
|
-3.37 units on a scale
Standard Deviation 4.37
|
-2.48 units on a scale
Standard Deviation 3.93
|
SECONDARY outcome
Timeframe: baseline to 28 daysPopulation: participant must have had at least one post baseline efficacy assessment
change from baseline in 12-hour instantaneous total nasal symptom score (TNSS) for the entire 28-day study period compared to placebo,scored on a 0 to 24 scale with 0 being no symptoms and 24 being severe symptoms.
Outcome measures
| Measure |
MP03-36 (0.15% Solution)
n=159 Participants
822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
|
MP03-33 (0.10% Solution)
n=165 Participants
548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
|
Placebo
n=161 Participants
0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
|
|---|---|---|---|
|
Change From Baseline in the Instantaneous Total Nasal Symptoms Score (TNSS) for the Entire 28-day Study Period Compared to Placebo
|
-2.70 units on a scale
Standard Deviation 3.91
|
-3.00 units on a scale
Standard Deviation 4.42
|
-2.38 units on a scale
Standard Deviation 3.95
|
SECONDARY outcome
Timeframe: baseline to 28 daysPopulation: participant must have had at least one post baseline efficacy assessment
change from baseline in 12-hour instantaneous total ocular symptom score (TOSS) for the entire 28-day study period compared to placebo,scored on a 0 to 18 scale with 0 being no symptoms and 18 being severe symptoms.
Outcome measures
| Measure |
MP03-36 (0.15% Solution)
n=157 Participants
822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
|
MP03-33 (0.10% Solution)
n=164 Participants
548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
|
Placebo
n=160 Participants
0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
|
|---|---|---|---|
|
Change From Baseline in 12-hour Reflective Total Ocular Symptoms Score (TOSS) and Instantaneous Total Ocular Symptoms Score (TOSS) for the Entire 28-day Study Period Compared to Placebo
|
-1.46 units on a scale
Standard Deviation 2.72
|
-1.51 units on a scale
Standard Deviation 3.12
|
-1.28 units on a scale
Standard Deviation 3.01
|
SECONDARY outcome
Timeframe: baseline to 28 DaysPopulation: participant must have had at least one post baseline efficacy assessment
change from baseline in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) compared to placebo for the entire 28-day study period compared to placebo,scored on a 0 to 42 scale with 0 being not troubled at all and 42 being extremely troublesome.
Outcome measures
| Measure |
MP03-36 (0.15% Solution)
n=158 Participants
822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
|
MP03-33 (0.10% Solution)
n=164 Participants
548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
|
Placebo
n=160 Participants
0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
|
|---|---|---|---|
|
Change From Baseline to Visit 4 in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Compared to Placebo
|
-0.30 units on a scale
Standard Deviation 0.95
|
-0.38 units on a scale
Standard Deviation 0.87
|
-0.38 units on a scale
Standard Deviation 0.83
|
Adverse Events
MP03-36 (0.15% Solution)
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
MP03-33 (0.10% Solution)
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MP03-36 (0.15% Solution)
n=161 participants at risk
822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
|
MP03-33 (0.10% Solution)
n=166 participants at risk
548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
|
Placebo
n=162 participants at risk
0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
epistaxis
|
4.3%
7/161 • Number of events 7
|
4.8%
8/166 • Number of events 8
|
3.1%
5/162 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
nasal discomfort
|
4.3%
7/161 • Number of events 7
|
0.60%
1/166 • Number of events 1
|
0.00%
0/162
|
|
Respiratory, thoracic and mediastinal disorders
dysgeusia
|
3.7%
6/161 • Number of events 6
|
2.4%
4/166 • Number of events 4
|
0.62%
1/162 • Number of events 1
|
|
Infections and infestations
uri
|
2.5%
4/161 • Number of events 4
|
2.4%
4/166 • Number of events 4
|
1.9%
3/162 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
sneezing
|
2.5%
4/161 • Number of events 4
|
1.8%
3/166 • Number of events 3
|
1.2%
2/162 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
oropharyngeal pain
|
1.9%
3/161 • Number of events 3
|
0.60%
1/166 • Number of events 1
|
1.2%
2/162 • Number of events 2
|
|
General disorders
pyrexia
|
1.2%
2/161 • Number of events 2
|
1.2%
2/166 • Number of events 2
|
1.9%
3/162 • Number of events 3
|
|
Gastrointestinal disorders
abdominal discomfort
|
1.2%
2/161 • Number of events 2
|
0.00%
0/166
|
0.00%
0/162
|
|
Infections and infestations
nasopharynigitis
|
0.62%
1/161 • Number of events 1
|
3.0%
5/166 • Number of events 5
|
1.9%
3/162 • Number of events 3
|
|
Nervous system disorders
headache
|
0.62%
1/161 • Number of events 1
|
1.8%
3/166 • Number of events 3
|
2.5%
4/162 • Number of events 4
|
|
Gastrointestinal disorders
vomiting
|
0.62%
1/161 • Number of events 1
|
0.00%
0/166
|
3.1%
5/162 • Number of events 5
|
|
Infections and infestations
otitis media
|
0.62%
1/161 • Number of events 1
|
0.00%
0/166
|
1.2%
2/162 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
rash
|
0.00%
0/161
|
1.2%
2/166 • Number of events 2
|
0.62%
1/162 • Number of events 1
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/161
|
0.60%
1/166 • Number of events 1
|
2.5%
4/162 • Number of events 4
|
|
Infections and infestations
pharyngitis streptoccal
|
0.00%
0/161
|
0.60%
1/166 • Number of events 1
|
1.2%
2/162 • Number of events 2
|
Additional Information
Sr.Director Medical Scientific Affairs
Meda Pharmaceuticals Inc
Phone: 732 564 2200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place