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

Allergic Rhinitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00772304
• Other study ID #: SMA-08-21
• Status: Completed
• Phase: Phase 4
• First received: October 13, 2008
• Last updated: February 23, 2010
• Start date: October 2008

Study information

• Verified date: February 2010
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis

Intervention

Drug:
• Olopatadine 0.6% / Azelastine 137 mcg
single dose; 2 sprays per nostril

Locations

Country	Name	City	State
United States	Alcon Call Center for Trial Locations	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Product Preference Questionnaire for Immediate Taste	Using a set of coded responses, subjects evaluated product preference in regards to immediate taste	5 min post-dose	No
Secondary	Taste and Aftertaste of Medication		5 min, 45 min.	No