Trial Outcomes & Findings for Safety Study of Olopatadine Nasal Spray (NCT NCT00578331)
NCT ID: NCT00578331
Last Updated: 2017-10-31
Results Overview
Mean Patient-Rated Relief Assessment at Day 30. The patient-rated relief assessment (PRRA) was a 4-point scale with 1=Complete Relief; 2=Moderate Relief; 3=Mild Relief; and 4=No Relief.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
890 participants
Primary outcome timeframe
day 30
Results posted on
2017-10-31
Participant Flow
Patients were recruited between December 2006 and January 2007 at medical offices in the United States.
Patients were randomized at Visit 1 upon meeting inclusion/exclusion.
Participant milestones
| Measure |
Placebo Nasal Spray
2 sprays each nostril twice daily
|
Olopatadine 0.6% Nasal Spray
2 sprays each nostril twice daily
|
|---|---|---|
|
Overall Study
STARTED
|
445
|
445
|
|
Overall Study
COMPLETED
|
329
|
320
|
|
Overall Study
NOT COMPLETED
|
116
|
125
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety Study of Olopatadine Nasal Spray
Baseline characteristics by cohort
| Measure |
Placebo Nasal Spray
n=445 Participants
|
Olopatadine 0.6% Nasal Spray
n=445 Participants
|
Total
n=890 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
53 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
383 Participants
n=5 Participants
|
388 Participants
n=7 Participants
|
771 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
296 Participants
n=5 Participants
|
282 Participants
n=7 Participants
|
578 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
149 Participants
n=5 Participants
|
163 Participants
n=7 Participants
|
312 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: day 30Population: 29 patients had missing mean patient-rated relief assessment data.
Mean Patient-Rated Relief Assessment at Day 30. The patient-rated relief assessment (PRRA) was a 4-point scale with 1=Complete Relief; 2=Moderate Relief; 3=Mild Relief; and 4=No Relief.
Outcome measures
| Measure |
Placebo Nasal Spray
n=430 Participants
|
Olopatadine 0.6% Nasal Spray
n=431 Participants
|
|---|---|---|
|
Mean Response at Day 30 to the Patient-rated Relief Assessment Questionnaire
|
2.7 Unit on PRRA scale
Standard Deviation 0.9
|
2.5 Unit on PRRA scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Month 1 through Month 12Population: 12 patients had missing average use of rescue medication data.
Outcome measures
| Measure |
Placebo Nasal Spray
n=439 Participants
|
Olopatadine 0.6% Nasal Spray
n=439 Participants
|
|---|---|---|
|
Average Number of Days of Rescue Medication Taken
|
10.2 Days
Standard Deviation 22.4
|
11.8 Days
Standard Deviation 26.6
|
Adverse Events
Placebo Nasal Spray
Serious events: 15 serious events
Other events: 319 other events
Deaths: 0 deaths
Olopatadine 0.6% Nasal Spray
Serious events: 15 serious events
Other events: 309 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Nasal Spray
n=445 participants at risk
|
Olopatadine 0.6% Nasal Spray
n=445 participants at risk
|
|---|---|---|
|
Infections and infestations
Appendicitis
|
0.22%
1/445 • Number of events 1 • 1 year
|
0.00%
0/445 • 1 year
|
|
Surgical and medical procedures
Cholecystectomy
|
0.00%
0/445 • 1 year
|
0.22%
1/445 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Depression
|
0.00%
0/445 • 1 year
|
0.67%
3/445 • Number of events 3 • 1 year
|
|
Gastrointestinal disorders
Faecaloma
|
0.22%
1/445 • Number of events 1 • 1 year
|
0.00%
0/445 • 1 year
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.22%
1/445 • Number of events 1 • 1 year
|
0.00%
0/445 • 1 year
|
|
Reproductive system and breast disorders
Genital prolapse
|
0.22%
1/445 • Number of events 1 • 1 year
|
0.00%
0/445 • 1 year
|
|
Nervous system disorders
Headache
|
0.22%
1/445 • Number of events 1 • 1 year
|
0.00%
0/445 • 1 year
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.22%
1/445 • Number of events 1 • 1 year
|
0.00%
0/445 • 1 year
|
|
Congenital, familial and genetic disorders
Hip dysplasia
|
0.00%
0/445 • 1 year
|
0.22%
1/445 • Number of events 1 • 1 year
|
|
Pregnancy, puerperium and perinatal conditions
Hyperemesis gravidarum
|
0.00%
0/445 • 1 year
|
0.22%
1/445 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Hysterectomy
|
0.22%
1/445 • Number of events 1 • 1 year
|
0.00%
0/445 • 1 year
|
|
Injury, poisoning and procedural complications
Injury
|
0.67%
3/445 • Number of events 4 • 1 year
|
0.45%
2/445 • Number of events 2 • 1 year
|
|
Surgical and medical procedures
Intervertebral disc operation
|
0.22%
1/445 • Number of events 1 • 1 year
|
0.00%
0/445 • 1 year
|
|
Surgical and medical procedures
Joint surgery
|
0.22%
1/445 • Number of events 1 • 1 year
|
0.00%
0/445 • 1 year
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.00%
0/445 • 1 year
|
0.22%
1/445 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/445 • 1 year
|
0.22%
1/445 • Number of events 1 • 1 year
|
|
Vascular disorders
Peripheral embolism
|
0.00%
0/445 • 1 year
|
0.22%
1/445 • Number of events 2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.22%
1/445 • Number of events 2 • 1 year
|
0.00%
0/445 • 1 year
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.22%
1/445 • Number of events 1 • 1 year
|
0.00%
0/445 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/445 • 1 year
|
0.22%
1/445 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/445 • 1 year
|
0.22%
1/445 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.00%
0/445 • 1 year
|
0.22%
1/445 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Thyroidectomy
|
0.22%
1/445 • Number of events 1 • 1 year
|
0.00%
0/445 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.22%
1/445 • Number of events 1 • 1 year
|
0.22%
1/445 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.22%
1/445 • Number of events 1 • 1 year
|
0.00%
0/445 • 1 year
|
Other adverse events
| Measure |
Placebo Nasal Spray
n=445 participants at risk
|
Olopatadine 0.6% Nasal Spray
n=445 participants at risk
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
28.3%
126/445 • Number of events 212 • 1 year
|
24.9%
111/445 • Number of events 189 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
14.6%
65/445 • Number of events 148 • 1 year
|
10.3%
46/445 • Number of events 97 • 1 year
|
|
Nervous system disorders
Headache
|
12.6%
56/445 • Number of events 110 • 1 year
|
12.8%
57/445 • Number of events 123 • 1 year
|
|
Infections and infestations
Rhinitis
|
16.4%
73/445 • Number of events 108 • 1 year
|
19.6%
87/445 • Number of events 126 • 1 year
|
|
Infections and infestations
Upper respiratory tract infection
|
16.9%
75/445 • Number of events 102 • 1 year
|
16.4%
73/445 • Number of events 97 • 1 year
|
|
Infections and infestations
Nasopharyngitis
|
15.1%
67/445 • Number of events 90 • 1 year
|
16.2%
72/445 • Number of events 98 • 1 year
|
|
Infections and infestations
Sinusitis
|
13.0%
58/445 • Number of events 72 • 1 year
|
14.8%
66/445 • Number of events 96 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Nasal ulcer
|
8.5%
38/445 • Number of events 52 • 1 year
|
10.3%
46/445 • Number of events 62 • 1 year
|
|
Immune system disorders
Seasonal allergy
|
6.5%
29/445 • Number of events 62 • 1 year
|
6.3%
28/445 • Number of events 44 • 1 year
|
|
Injury, poisoning and procedural complications
Injury
|
11.0%
49/445 • Number of events 61 • 1 year
|
7.0%
31/445 • Number of events 34 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
5.4%
24/445 • Number of events 33 • 1 year
|
6.5%
29/445 • Number of events 36 • 1 year
|
|
Nervous system disorders
Sinus headache
|
5.2%
23/445 • Number of events 42 • 1 year
|
3.4%
15/445 • Number of events 21 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.2%
23/445 • Number of events 29 • 1 year
|
5.2%
23/445 • Number of events 32 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.8%
26/445 • Number of events 29 • 1 year
|
4.7%
21/445 • Number of events 24 • 1 year
|
|
Infections and infestations
Bronchitis
|
4.3%
19/445 • Number of events 21 • 1 year
|
5.2%
23/445 • Number of events 25 • 1 year
|
|
Nervous system disorders
Dysgeusia
|
0.67%
3/445 • Number of events 3 • 1 year
|
6.5%
29/445 • Number of events 30 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER