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

This study has been completed.

Study NCT00772304 Information provided by Alcon Research

First Received on October 13, 2008. Last Updated on February 23, 2010 History of Changes

Results First Received: December 3, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Allergic Rhinitis
Intervention:	Drug: Olopatadine 0.6% / Azelastine 137 mcg

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
October 2008- November 2008

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Olopatadine 0.6% / Azelastine 137 Mcg	Olopatadine 0.6% / Azelastine 137 mcg

Participant Flow: Overall Study

	Olopatadine 0.6% / Azelastine 137 Mcg
STARTED	102
COMPLETED	102
NOT COMPLETED	0

Baseline Characteristics

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Reporting Groups

	Description
Olopatadine 0.6% / Azelastine 137 Mcg	Olopatadine 0.6% / Azelastine 137 mcg

Baseline Measures

	Olopatadine 0.6% / Azelastine 137 Mcg
Number of Participants [units: participants]	102
Age [units: participants]
<=18 years	0
Between 18 and 65 years	101
>=65 years	1
Gender [units: participants]
Female	74
Male	28

Outcome Measures

1. Primary:

Product Preference Questionnaire for Immediate Taste [ Time Frame: 5 min post-dose ]

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2. Secondary:

Taste and Aftertaste of Medication [ Time Frame: 5 min, 45 min. ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Small sample size. The severity of symptoms experienced by patients may have masked their ability to detect taste and smell.

Results Point of Contact:

Name/Title: Alcon Clinical
Organization: Alcon Research, Ltd.
phone: 888.451.3937; 817.568.6725
e-mail: medinfo@alconlabs.com

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