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

NCT00772304 | Completed Phase 4 Results

• 1 other identifier: SMA-08-21
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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

Keywords

rhinitis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Taste and Aftertaste of Medication

  5 min, 45 min.

Study Arms (1)

1

EXPERIMENTAL

Olopatadine 0.6% / Azelastine 137 mcg

Drug: Olopatadine 0.6% / Azelastine 137 mcg

Interventions

Olopatadine 0.6% / Azelastine 137 mcg DRUG

single dose; 2 sprays per nostril

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have a history (at least 2 yrs) of allergic rhinitis and be symptomatic at time of enrollment
• yrs of age or older
• Read and sign informed consent
• 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.

You may not qualify if:

• History of intolerance or hypersensitivity to any component of the study medications, including benzalkonium chloride.
• 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.
• Impairment of sense of tast or smell (self reported)
• Asthma, except for mild, intermittent asthma (nat'l Asthma guidelines)
• Congestion, that in the opinion of the investigator, that would interfere with successful nasal drug administration/absorption
• Patients w/a severe impairment of nasal breathing
• Anatomic abnormalities of as identified by nasal examination
• History of or current severe or uncontrolled cardiovascular, hepatic, renal and/or other disease/illness that could interfere w/study.
• History of (w/in past 12 months) or ongoing clinically relevant electrolyte abnormalities.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Rhinitis, Allergic; Rhinitis

Interventions

Olopatadine Hydrochloride; azelastine

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiratory Tract Infections; Infections

Intervention Hierarchy (Ancestors)

Dibenzoxepins; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Small sample size. The severity of symptoms experienced by patients may have masked their ability to detect taste and smell.

Results Point of Contact

• Title: Alcon Clinical
• Organization: Alcon Research, Ltd.

medinfo@alconlabs.com

888.451.3937; 817.568.6725

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 13, 2008
• First Posted: October 15, 2008
• Study Start: October 1, 2008
• Primary Completion: November 1, 2008
• Last Updated: March 2, 2010
• Results First Posted: February 2, 2010

Record last verified: 2010-02

Locations

US (1)