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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00772304
Recruitment Status : Completed
First Posted : October 15, 2008
Results First Posted : February 2, 2010
Last Update Posted : March 2, 2010
Information provided by:
Alcon Research

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.

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Drug: Olopatadine 0.6% / Azelastine 137 mcg Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : October 2008
Actual Primary Completion Date : November 2008

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Taste and Aftertaste of Medication [ Time Frame: 5 min, 45 min. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00772304

United States, Texas
Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research

Responsible Party: Michael Edwards, PhD\Global Scientific Market Affairs, Alcon Research Identifier: NCT00772304     History of Changes
Other Study ID Numbers: SMA-08-21
First Posted: October 15, 2008    Key Record Dates
Results First Posted: February 2, 2010
Last Update Posted: March 2, 2010
Last Verified: February 2010

Keywords provided by Alcon Research:

Additional relevant MeSH terms:
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Olopatadine Hydrochloride
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents