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

Primary Purpose

Allergic Rhinitis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Olopatadine 0.6% / Azelastine 137 mcg
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis focused on measuring rhinitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Alcon Call Center for Trial Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Olopatadine 0.6% / Azelastine 137 mcg

Outcomes

Primary Outcome Measures

Product Preference Questionnaire for Immediate Taste
Using a set of coded responses, subjects evaluated product preference in regards to immediate taste

Secondary Outcome Measures

Taste and Aftertaste of Medication

Full Information

First Posted
October 13, 2008
Last Updated
February 23, 2010
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT00772304
Brief Title
Evaluation of the Sensory Attributes of Olopatadine 0.6% and Azelastine 137mcg Nasal Sprays in Patients w/Allergic Rhinitis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Alcon Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis
Keywords
rhinitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Olopatadine 0.6% / Azelastine 137 mcg
Intervention Type
Drug
Intervention Name(s)
Olopatadine 0.6% / Azelastine 137 mcg
Intervention Description
single dose; 2 sprays per nostril
Primary Outcome Measure Information:
Title
Product Preference Questionnaire for Immediate Taste
Description
Using a set of coded responses, subjects evaluated product preference in regards to immediate taste
Time Frame
5 min post-dose
Secondary Outcome Measure Information:
Title
Taste and Aftertaste of Medication
Time Frame
5 min, 45 min.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Must have a history (at least 2 yrs) of allergic rhinitis and be symptomatic at time of enrollment 18 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
Alcon Call Center for Trial Locations
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States

12. IPD Sharing Statement

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

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