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

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00772304
First received: October 13, 2008
Last updated: February 23, 2010
Last verified: February 2010
  Purpose

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 Intervention Phase
Allergic Rhinitis
Drug: Olopatadine 0.6% / Azelastine 137 mcg
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Product Preference Questionnaire for Immediate Taste [ Time Frame: 5 min post-dose ] [ Designated as safety issue: No ]
    Using a set of coded responses, subjects evaluated product preference in regards to immediate taste


Secondary Outcome Measures:
  • Taste and Aftertaste of Medication [ Time Frame: 5 min, 45 min. ] [ Designated as safety issue: No ]

Enrollment: 102
Study Start Date: October 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Olopatadine 0.6% / Azelastine 137 mcg
Drug: Olopatadine 0.6% / Azelastine 137 mcg
single dose; 2 sprays per nostril

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00772304

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

No publications provided

Responsible Party: Michael Edwards, PhD\Global Scientific Market Affairs, Alcon Research
ClinicalTrials.gov Identifier: NCT00772304     History of Changes
Other Study ID Numbers: SMA-08-21
Study First Received: October 13, 2008
Results First Received: December 3, 2009
Last Updated: February 23, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
rhinitis

Additional relevant MeSH terms:
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Azelastine
Olopatadine
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Lipoxygenase Inhibitors
Enzyme Inhibitors
Anti-Allergic Agents
Therapeutic Uses
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 16, 2014