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OpenTrials
Completed

NCT Number: NCT00772304

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

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.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Olopatadine 0.6% / Azelastine 137 mcg

Drug

single dose; 2 sprays per nostril

Primary outcomes

  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 outcomes

  1. Taste and Aftertaste of Medication

    Time frame: 5 min, 45 min.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2008
Primary completion
2008
First posted
Oct 15, 2008
Registry last updated
Mar 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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