Evaluation of the Sensory Attributes of Olapatadine 0.6% and Azelastine 137mcg Nasal Sprays in Patients w/Allergic Rhinitis

Condition(s) targeted: Allergic Rhinitis

Intervention: Olapatidine 0.6% (Drug); Azelastine 137mcg (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Alcon Research

Overall contact:
Alcon Call Center, Phone: 1-888-451-3937

To compare patient perceptions of the sensory attributes, including taste and aftertaste, of Olapatadine relative to azelastine when administered as a single dose in patients with allergic rhinitis.

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment

Primary outcome: Taste of the medication

Secondary outcome: Taste and aftertaste of medication

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 uring 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 electolyte abnormalities.

Alcon Call Center, Phone: 1-888-451-3937

Alcon Call Center for Trial Locations, Fort Worth, Texas 76134, United States

Starting date: October 2008
Last updated: October 13, 2008