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

Alcon

Status and phase: Completed; Phase 4

Conditions: Allergic Rhinitis

Treatments: Drug: Olopatadine 0.6% / Azelastine 137 mcg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00772304

SMA-08-21

Details and patient eligibility

About

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.

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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102 participants in 1 patient group

1

Experimental group

Description:

Olopatadine 0.6% / Azelastine 137 mcg

Treatment:

Drug: Olopatadine 0.6% / Azelastine 137 mcg