Trial Outcomes & Findings for Evaluation of the Sensory Attributes of Olopatadine 0.6% and Azelastine 137mcg Nasal Sprays in Patients w/Allergic Rhinitis (NCT NCT00772304)
NCT ID: NCT00772304
Last Updated: 2010-03-02
Results Overview
Using a set of coded responses, subjects evaluated product preference in regards to immediate taste
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
102 participants
Primary outcome timeframe
5 min post-dose
Results posted on
2010-03-02
Participant Flow
October 2008- November 2008
Participant milestones
| Measure |
Olopatadine 0.6% / Azelastine 137 Mcg
Olopatadine 0.6% / Azelastine 137 mcg
|
|---|---|
|
Overall Study
STARTED
|
102
|
|
Overall Study
COMPLETED
|
102
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of the Sensory Attributes of Olopatadine 0.6% and Azelastine 137mcg Nasal Sprays in Patients w/Allergic Rhinitis
Baseline characteristics by cohort
| Measure |
Olopatadine 0.6% / Azelastine 137 Mcg
n=102 Participants
Olopatadine 0.6% / Azelastine 137 mcg
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
101 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 min post-doseUsing a set of coded responses, subjects evaluated product preference in regards to immediate taste
Outcome measures
| Measure |
Olopatadine 0.6% / Azelastine 137 Mcg
n=102 Participants
Olopatadine 0.6% / Azelastine 137 mcg
|
|---|---|
|
Product Preference Questionnaire for Immediate Taste
Preferred Azelastine Strongly
|
26.47 Percentage of participants
|
|
Product Preference Questionnaire for Immediate Taste
Preferred Azelastine Somewhat
|
10.78 Percentage of participants
|
|
Product Preference Questionnaire for Immediate Taste
Preferred Azelastine Slightly
|
5.88 Percentage of participants
|
|
Product Preference Questionnaire for Immediate Taste
Same
|
15.69 Percentage of participants
|
|
Product Preference Questionnaire for Immediate Taste
Preferred Olopatadine Slightly
|
8.82 Percentage of participants
|
|
Product Preference Questionnaire for Immediate Taste
Preferred Olopatadine Somewhat
|
8.82 Percentage of participants
|
|
Product Preference Questionnaire for Immediate Taste
Preferred Olopatadine Strongly
|
23.53 Percentage of participants
|
SECONDARY outcome
Timeframe: 5 min, 45 min.Outcome measures
Outcome data not reported
Adverse Events
Olopatadine 0.6% / Azelastine 137 Mcg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place