Safety and Efficacy of Olopatadine 0.6% and Azelastine 137 Mcg in Vasomotor Rhinitis

This study has been completed.

Study NCT00979615 Information provided by Alcon Research

First Received on September 17, 2009. Last Updated on April 14, 2011 History of Changes

Results First Received: April 14, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Vasomotor Rhinitis
Interventions:	Drug: Olopatadine HCL (Patanase) Nasal Spray, 0.6% Drug: Azelastine HCl (Astelin) Nasal Spray, 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
September 9, 2009 - November 13, 2009

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Olopatadine HCL	Olopatadine HCL Nasal Spray, 0.6%
Azelastine HCl	Azelastine HCl Nasal Spray, 137 mcg

Participant Flow: Overall Study

	Olopatadine HCL	Azelastine HCl
STARTED	63	66
COMPLETED	57	58
NOT COMPLETED	6	8

Baseline Characteristics

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Reporting Groups

	Description
Olopatadine HCL	Olopatadine HCL Nasal Spray, 0.6%
Azelastine HCl	Azelastine HCl Nasal Spray, 137 mcg

Baseline Measures

	Olopatadine HCL	Azelastine HCl	Total
Number of Participants [units: participants]	57	58	115
Age [units: participants]
<=18 years	2	4	6
Between 18 and 65 years	51	54	105
>=65 years	4	0	4
Gender [units: participants]
Female	39	46	85
Male	18	12	30

Outcome Measures

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1. Primary:

Mean Change in 2-week rTNSS From Baseline [ Time Frame: 2 week ]

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2. Secondary:

Mean Change in Rhinorrhea Reflective Score [ Time Frame: 2 week ]

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3. Secondary:

Mean Change Postnasal Drip Reflective Score [ Time Frame: 2 Weeks ]

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4. Secondary:

Mean Change Nasal Congestion Reflective Score [ Time Frame: 2 Weeks ]

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5. Secondary:

Mean Change in Sneezing Reflective Score [ Time Frame: 2 Weeks ]

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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
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Results Point of Contact:

Name/Title: Maria J. Tort, PhD
Organization: Alcon Research, Ltd.
phone: (817) 302-5968
e-mail: Maria.Tort@alconlabs.com

No publications provided

Responsible Party:	Maria Tort, PhD, Manager, Global Medical Affairs, Alcon Research Ltd
ClinicalTrials.gov Identifier:	NCT00979615 History of Changes
Other Study ID Numbers:	SMA-09-03
Study First Received:	September 17, 2009
Results First Received:	April 14, 2011
Last Updated:	April 14, 2011
Health Authority:	United States: Food and Drug Administration