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

NCT ID: NCT00772304

Last Updated: 2010-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31

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.

Conditions

Allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Olopatadine 0.6% / Azelastine 137 mcg

Group Type: EXPERIMENTAL

Olopatadine 0.6% / Azelastine 137 mcg

Intervention Type: DRUG

single dose; 2 sprays per nostril

Interventions

Olopatadine 0.6% / Azelastine 137 mcg

single dose; 2 sprays per nostril

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Alcon Research

Locations

Alcon Call Center for Trial Locations

Fort Worth, Texas, United States

Countries

United States

Other Identifiers

SMA-08-21

Identifier Type: -

Identifier Source: org_study_id