Trial Outcomes & Findings for Safety and Efficacy of Olopatadine HCl Nasal Spray in 6-11 Year Old Patients (NCT NCT00578929)
NCT ID: NCT00578929
Last Updated: 2010-03-02
Results Overview
Total Nasal Symptom Score comprised of scoring each of the following symptoms: runny nose, stuffy nose, itchy nose, and sneezing. Each symptom was scored as a 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The 4 individual symptom scores were then added together for a total nasal symptom score. The percent change from baseline was defined as the average of the morning and evening severity scores for the sum of the assessments of the 4 individual scores averaged across all days.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2388 participants
Primary outcome timeframe
Baseline through 2 weeks after randomization
Results posted on
2010-03-02
Participant Flow
The first subject was enrolled in the study on September 8, 2007 and the last subject exited the study on November 24, 2008. The study was conducted at medical clinics throughout the USA.
Subjects completed a 4-16 day run-in period on vehicle prior to randomization.
Participant milestones
| Measure |
Olopatadine 0.6% 1 Spray
Olopatadine HCl 0.6% 1 spray per nostril twice daily
|
Vehicle 1 Spray
Vehicle 1 spray per nostril twice daily
|
Olopatadine 0.6% 2 Sprays
Olopatadine HCl 0.6% 2 Sprays per nostril twice daily
|
Vehicle 2 Sprays
Vehicle 2 sprays per nostril twice daily
|
|---|---|---|---|---|
|
Vehicle Run-In Period
STARTED
|
0
|
2388
|
0
|
0
|
|
Vehicle Run-In Period
COMPLETED
|
0
|
2388
|
0
|
0
|
|
Vehicle Run-In Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Randomized Period
STARTED
|
298
|
297
|
296
|
297
|
|
Randomized Period
COMPLETED
|
281
|
283
|
288
|
283
|
|
Randomized Period
NOT COMPLETED
|
17
|
14
|
8
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of Olopatadine HCl Nasal Spray in 6-11 Year Old Patients
Baseline characteristics by cohort
| Measure |
Olopatadine 0.6% 1 Spray
n=298 Participants
Olopatadine HCl 0.6% 1 spray per nostril twice daily
|
Vehicle 1 Spray
n=297 Participants
Vehicle 1 spray per nostril twice daily
|
Olopatadine 0.6% 2 Sprays
n=296 Participants
Olopatadine HCl 0.6% 2 Sprays per nostril twice daily
|
Vehicle 2 Sprays
n=297 Participants
Vehicle 2 sprays per nostril twice daily
|
Total
n=1188 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
298 Participants
n=5 Participants
|
297 Participants
n=7 Participants
|
296 Participants
n=5 Participants
|
297 Participants
n=4 Participants
|
1188 Participants
n=21 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
|
0 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
130 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
124 Participants
n=4 Participants
|
501 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
168 Participants
n=5 Participants
|
172 Participants
n=7 Participants
|
174 Participants
n=5 Participants
|
173 Participants
n=4 Participants
|
687 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline through 2 weeks after randomizationTotal Nasal Symptom Score comprised of scoring each of the following symptoms: runny nose, stuffy nose, itchy nose, and sneezing. Each symptom was scored as a 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The 4 individual symptom scores were then added together for a total nasal symptom score. The percent change from baseline was defined as the average of the morning and evening severity scores for the sum of the assessments of the 4 individual scores averaged across all days.
Outcome measures
| Measure |
Olopatadine 0.6% 1 Spray
n=298 Participants
Olopatadine HCl 0.6% 1 spray per nostril twice daily
|
Vehicle 1 Spray
n=297 Participants
Vehicle 1 spray per nostril twice daily
|
Olopatadine 0.6% 2 Sprays
n=296 Participants
Olopatadine HCl 0.6% 2 Sprays per nostril twice daily
|
Vehicle 2 Sprays
n=297 Participants
Vehicle 2 sprays per nostril twice daily
|
|---|---|---|---|---|
|
Percent Change From Baseline in the Reflective Total Nasal Symptom Score (TNSS)
|
-25.10 Percent change of TNSS from baseline
Standard Error 1.45
|
-18.17 Percent change of TNSS from baseline
Standard Error 1.45
|
-26.35 Percent change of TNSS from baseline
Standard Error 1.45
|
-21.21 Percent change of TNSS from baseline
Standard Error 1.45
|
SECONDARY outcome
Timeframe: Baseline through 2 weeks after randomizationTotal Ocular Symptom Score comprised of scoring each of the following symptoms: itchy eyes and watery eyes. Each symptom was scored as a 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The 2 individual symptom scores were then added together for a total ocular symptom score. The percent change from baseline was defined as the average of the morning and evening severity scores for the sum of the assessments of the 2 individual scores averaged across all days.
Outcome measures
| Measure |
Olopatadine 0.6% 1 Spray
n=298 Participants
Olopatadine HCl 0.6% 1 spray per nostril twice daily
|
Vehicle 1 Spray
n=297 Participants
Vehicle 1 spray per nostril twice daily
|
Olopatadine 0.6% 2 Sprays
n=296 Participants
Olopatadine HCl 0.6% 2 Sprays per nostril twice daily
|
Vehicle 2 Sprays
n=297 Participants
Vehicle 2 sprays per nostril twice daily
|
|---|---|---|---|---|
|
Percent Change From Baseline in the Reflective Total Ocular Symptom Score (TOSS)
|
-25.02 Percent change of TOSS from baseline
Standard Error 5.11
|
-6.09 Percent change of TOSS from baseline
Standard Error 5.10
|
-25.03 Percent change of TOSS from baseline
Standard Error 3.33
|
-9.46 Percent change of TOSS from baseline
Standard Error 3.37
|
Adverse Events
Olopatadine 0.6% 1 Spray
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Vehicle 1 Spray
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Olopatadine 0.6% 2 Sprays
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Vehicle 2 Sprays
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Vehicle Run-in Period
Serious events: 1 serious events
Other events: 107 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Olopatadine 0.6% 1 Spray
n=298 participants at risk
Olopatadine HCl 0.6% 1 spray per nostril twice daily
|
Vehicle 1 Spray
n=297 participants at risk
Vehicle 1 spray per nostril twice daily
|
Olopatadine 0.6% 2 Sprays
n=296 participants at risk
Olopatadine HCl 0.6% 2 Sprays per nostril twice daily
|
Vehicle 2 Sprays
n=297 participants at risk
Vehicle 2 sprays per nostril twice daily
|
Vehicle Run-in Period
n=2388 participants at risk
Vehicle Run-in Period
|
|---|---|---|---|---|---|
|
Nervous system disorders
Syncope vasovagal
|
0.00%
0/298 • Up to 3 weeks
Adverse events were collected from the time of first dose with vehicle run-in until study exit. Adverse events were both volunteered and solicited
|
0.00%
0/297 • Up to 3 weeks
Adverse events were collected from the time of first dose with vehicle run-in until study exit. Adverse events were both volunteered and solicited
|
0.00%
0/296 • Up to 3 weeks
Adverse events were collected from the time of first dose with vehicle run-in until study exit. Adverse events were both volunteered and solicited
|
0.00%
0/297 • Up to 3 weeks
Adverse events were collected from the time of first dose with vehicle run-in until study exit. Adverse events were both volunteered and solicited
|
0.04%
1/2388 • Number of events 1 • Up to 3 weeks
Adverse events were collected from the time of first dose with vehicle run-in until study exit. Adverse events were both volunteered and solicited
|
Other adverse events
| Measure |
Olopatadine 0.6% 1 Spray
n=298 participants at risk
Olopatadine HCl 0.6% 1 spray per nostril twice daily
|
Vehicle 1 Spray
n=297 participants at risk
Vehicle 1 spray per nostril twice daily
|
Olopatadine 0.6% 2 Sprays
n=296 participants at risk
Olopatadine HCl 0.6% 2 Sprays per nostril twice daily
|
Vehicle 2 Sprays
n=297 participants at risk
Vehicle 2 sprays per nostril twice daily
|
Vehicle Run-in Period
n=2388 participants at risk
Vehicle Run-in Period
|
|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.7%
17/298 • Number of events 18 • Up to 3 weeks
Adverse events were collected from the time of first dose with vehicle run-in until study exit. Adverse events were both volunteered and solicited
|
3.7%
11/297 • Number of events 12 • Up to 3 weeks
Adverse events were collected from the time of first dose with vehicle run-in until study exit. Adverse events were both volunteered and solicited
|
6.1%
18/296 • Number of events 19 • Up to 3 weeks
Adverse events were collected from the time of first dose with vehicle run-in until study exit. Adverse events were both volunteered and solicited
|
5.4%
16/297 • Number of events 18 • Up to 3 weeks
Adverse events were collected from the time of first dose with vehicle run-in until study exit. Adverse events were both volunteered and solicited
|
1.8%
42/2388 • Number of events 44 • Up to 3 weeks
Adverse events were collected from the time of first dose with vehicle run-in until study exit. Adverse events were both volunteered and solicited
|
|
Nervous system disorders
Headache
|
4.4%
13/298 • Number of events 15 • Up to 3 weeks
Adverse events were collected from the time of first dose with vehicle run-in until study exit. Adverse events were both volunteered and solicited
|
3.7%
11/297 • Number of events 11 • Up to 3 weeks
Adverse events were collected from the time of first dose with vehicle run-in until study exit. Adverse events were both volunteered and solicited
|
3.0%
9/296 • Number of events 9 • Up to 3 weeks
Adverse events were collected from the time of first dose with vehicle run-in until study exit. Adverse events were both volunteered and solicited
|
5.4%
16/297 • Number of events 16 • Up to 3 weeks
Adverse events were collected from the time of first dose with vehicle run-in until study exit. Adverse events were both volunteered and solicited
|
2.8%
68/2388 • Number of events 68 • Up to 3 weeks
Adverse events were collected from the time of first dose with vehicle run-in until study exit. Adverse events were both volunteered and solicited
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor reserves the right of review 60 days prior to any publication or presentation of information related to the study. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than study data and results. The Institution and the Primary Investigator agree not to publish any study related material other than above.
- Publication restrictions are in place
Restriction type: OTHER