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

Phase 4

Completed

• Conditions: Allergic Rhinitis
• Interventions: Drug: Olopatadine 0.6% / Azelastine 137 mcg

• Registration Number: NCT00772304
• Lead Sponsor: Alcon Research

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-13
• Study First Submitted QC: 2008-10-13
• Study First Posted: 2008-10-15
• Primary Completion: 2008-11
• Results First Submitted: 2009-12-03
• Results First Submitted QC: 2010-01-11
• Status Verified: 2010-02
• Results First Posted: 2010-02-02
• Last Update Submitted: 2010-02-23
• Last Update Posted: 2010-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Olopatadine 0.6% / Azelastine 137 mcg	Olopatadine 0.6% / Azelastine 137 mcg

Primary Outcome Measures

Name	Time	Method
Product Preference Questionnaire for Immediate Taste	5 min post-dose	Using a set of coded responses, subjects evaluated product preference in regards to immediate taste

Secondary Outcome Measures

Name	Time	Method
Taste and Aftertaste of Medication	5 min, 45 min.

Trial Locations

Locations (1)

Alcon Call Center for Trial Locations; 🇺🇸 Fort Worth, Texas, United States