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

February 23, 2010 updated by: Alcon Research
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Fort Worth, Texas, United States, 76134
        • Alcon Call Center for Trial Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Olopatadine 0.6% / Azelastine 137 mcg
Drug: Olopatadine 0.6% / Azelastine 137 mcg
single dose; 2 sprays per nostril

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Taste and Aftertaste of Medication
Time Frame: 5 min, 45 min.
5 min, 45 min.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

October 13, 2008

First Submitted That Met QC Criteria

October 13, 2008

First Posted (Estimate)

October 15, 2008

Study Record Updates

Last Update Posted (Estimate)

March 2, 2010

Last Update Submitted That Met QC Criteria

February 23, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMA-08-21

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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