Allergic Rhinitis
Conditions
Keywords
rhinitis
Brief summary
To compare patient perceptions of the sensory attributes, including taste and aftertaste, of Olopatadine relative to azelastine when administered as a single dose in patients with allergic rhinitis.
Interventions
DRUGOlopatadine 0.6% / Azelastine 137 mcg
single dose; 2 sprays per nostril
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Must have a history (at least 2 yrs) of allergic rhinitis and be symptomatic at time of enrollment 2. 18 yrs of age or older 3. Read and sign informed consent 4. Females of childbearing potential may participate if: are non-breast feeding, have negative urine pregnancy test at visit 1, agree to take urine pregnancy test upon exiting study, do not intend to become pregnant during the study, are using adequate methods of birth control.
Exclusion criteria
1. History of intolerance or hypersensitivity to any component of the study medications, including benzalkonium chloride. 2. Any disease or systemic disorder that may complicate or interfere with investigation or evaluation of the study medications (including but not limited to): Rhinitis medicamentosa, large obstructive nasal polyps, history (w/in last 3 months) of nasal septic ulcers, nasal surgery or nasal trauma, history or evidence of nasolacrimal drainage system malfunction, history (w/in 30 days) or evidence of sinusitis or upper or lower respiratory infection. 3. Impairment of sense of tast or smell (self reported) 4. Asthma, except for mild, intermittent asthma (nat'l Asthma guidelines) 5. Congestion, that in the opinion of the investigator, that would interfere with successful nasal drug administration/absorption 6. Patients w/a severe impairment of nasal breathing 7. Anatomic abnormalities of as identified by nasal examination 8. History of or current severe or uncontrolled cardiovascular, hepatic, renal and/or other disease/illness that could interfere w/study. 9. History of (w/in past 12 months) or ongoing clinically relevant electrolyte abnormalities.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Product Preference Questionnaire for Immediate Taste | 5 min post-dose | Using a set of coded responses, subjects evaluated product preference in regards to immediate taste |
Secondary
| Measure | Time frame |
|---|---|
| Taste and Aftertaste of Medication | 5 min, 45 min. |
Countries
United States
Participant flow
Recruitment details
October 2008- November 2008
Participants by arm
| Arm | Count |
|---|---|
| Olopatadine 0.6% / Azelastine 137 Mcg Olopatadine 0.6% / Azelastine 137 mcg | 102 |
| Total | 102 |
Baseline characteristics
| Characteristic | Olopatadine 0.6% / Azelastine 137 Mcg |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 101 Participants |
| Sex: Female, Male Female | 74 Participants |
| Sex: Female, Male Male | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 102 |
| serious Total, serious adverse events | 0 / 102 |
Outcome results
Primary
Product Preference Questionnaire for Immediate Taste
Using a set of coded responses, subjects evaluated product preference in regards to immediate taste
Time frame: 5 min post-dose
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Olopatadine 0.6% / Azelastine 137 Mcg | Product Preference Questionnaire for Immediate Taste | Preferred Azelastine Strongly | 26.47 Percentage of participants |
| Olopatadine 0.6% / Azelastine 137 Mcg | Product Preference Questionnaire for Immediate Taste | Preferred Azelastine Somewhat | 10.78 Percentage of participants |
| Olopatadine 0.6% / Azelastine 137 Mcg | Product Preference Questionnaire for Immediate Taste | Preferred Azelastine Slightly | 5.88 Percentage of participants |
| Olopatadine 0.6% / Azelastine 137 Mcg | Product Preference Questionnaire for Immediate Taste | Same | 15.69 Percentage of participants |
| Olopatadine 0.6% / Azelastine 137 Mcg | Product Preference Questionnaire for Immediate Taste | Preferred Olopatadine Slightly | 8.82 Percentage of participants |
| Olopatadine 0.6% / Azelastine 137 Mcg | Product Preference Questionnaire for Immediate Taste | Preferred Olopatadine Somewhat | 8.82 Percentage of participants |
| Olopatadine 0.6% / Azelastine 137 Mcg | Product Preference Questionnaire for Immediate Taste | Preferred Olopatadine Strongly | 23.53 Percentage of participants |
Secondary
Taste and Aftertaste of Medication
Time frame: 5 min, 45 min.