Evaluation of the Sensory Attributes of Olopatadine 0.6% and Azelastine 137mcg Nasal Sprays in Patients w/Allergic Rhinitis
Information source: Alcon Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Allergic Rhinitis
Intervention: Olopatadine 0.6% / Azelastine 137 mcg (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Alcon Research
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.
Clinical Details
Study design: Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Product Preference Questionnaire for Immediate Taste
Secondary outcome: Taste and Aftertaste of Medication
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Alcon Call Center for Trial Locations, Fort Worth, Texas 76134, United States
Additional Information
Starting date: October 2008
Last updated: February 23, 2010
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