Evaluation of the Sensory Attributes of Olopatadine 0.6% and Azelastine 137mcg Nasal Sprays in Patients w/Allergic Rhinitis | NCT00772304 | Trialant
CompletedInterventionalPhase 4Updated Mar 2, 2010
Evaluation of the Sensory Attributes of Olopatadine 0.6% and Azelastine 137mcg Nasal Sprays in Patients w/Allergic Rhinitis
ClinicalTrials.gov ID
NCT00772304
Lead Sponsor
Alcon ResearchINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 4
Enrollment
102Actual
Last Update Posted
Mar 2, 2010Estimated
Start Date
Oct 2008
Primary Completion Date
Nov 2008Actual
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.
Allergic Rhinitis
Olopatadine 0.6% / Azelastine 137 mcg
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
Yes
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.