Phase 4
N=102
Evaluation of the Sensory Attributes of Olopatadine 0.6% and Azelastine 137mcg Nasal Sprays in Patients w/Allergic Rhinitis
Allergic Rhinitis
Bottom Line
View on ClinicalTrials.gov: NCT00772304 ↗Enrolled (actual)
102
Serious AEs
0.0%
Results posted
Feb 2010
Primary outcome: Primary: Product Preference Questionnaire for Immediate Taste — 26.47; 10.78; 5.88; 15.69 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Olopatadine 0.6% / Azelastine 137 mcg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Product Preference Questionnaire for Immediate Taste |
26.47; 10.78; 5.88; 15.69; 8.82; 8.82 | — |
| SECONDARY Taste and Aftertaste of Medication |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- Must have a history (at least 2 yrs) of allergic rhinitis and be symptomatic at time of enrollment
- 18 yrs of age or older
- Read and sign informed consent
- 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
- History of intolerance or hypersensitivity to any component of the study medications, including benzalkonium chloride.
- 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.
- Impairment of sense of tast or smell (self reported)
- Asthma, except for mild, intermittent asthma (nat'l Asthma guidelines)
- Congestion, that in the opinion of the investigator, that would interfere with successful nasal drug administration/absorption
- Patients w/a severe impairment of nasal breathing
- Anatomic abnormalities of as identified by nasal examination
- History of or current severe or uncontrolled cardiovascular, hepatic, renal and/or other disease/illness that could interfere w/study.
- History of (w/in past 12 months) or ongoing clinically relevant electrolyte abnormalities.
Data sourced from ClinicalTrials.gov (NCT00772304). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.