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

This study has been completed.

First Received: September 17, 2009 Last Updated: January 22, 2010 History of Changes

Sponsor:	Alcon Research
Information provided by:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00979615

Purpose

The purpose of this study is to examine safety and efficacy of Patanase and Astelin in treating the symptoms of non-allergic vasomotor rhinitis (VMR).

Condition	Intervention	Phase
Vasomotor Rhinitis	Drug: Olopatadine HCL (Patanase) Nasal Spray, 0.6% Drug: Azelastine HCl (Astelin) Nasal Spray, 137 mcg	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment

Resource links provided by NLM:

Drug Information available for: Azelastine Azelastine hydrochloride Olopatadine Patanol

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:

Total Nasal VMR Symptoms Score [ Time Frame: 2 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Individual symptom severity scores [ Time Frame: 2 week ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	September 2009
Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Olopatadine HCL Nasal Spray, 0.6%	Drug: Olopatadine HCL (Patanase) Nasal Spray, 0.6% 2 sprays/ nostril BID
2: Active Comparator Azelastine HCl Nasal Spray, 137 mcg	Drug: Azelastine HCl (Astelin) Nasal Spray, 137 mcg 2 sprays/ nostril BID

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of VMR with at least 2 years of chronic non-allergic rhinitis
Negative skin tests to a panel of allergens and positive histamine test within last 2 years
History of symptoms related to defined VMR triggers

Exclusion Criteria:

Nasal disorder, surgery, or concurrent disease that could interfere with evaluation of study medications
Bacterial or viral infection within 14 days of first visit. Diagnosis of acute sinusitis within 30 days of first visit
Chronic use of drugs that can cause rhinitis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00979615

Locations

United States, Texas
Contact Alcon Call Center For Trial Locations
Fort Worth, Texas, United States, 76134

Sponsors and Collaborators

Alcon Research

More Information

No publications provided

Responsible Party:	Alcon Research Ltd ( Maria Tort, PhD, Manager, Global Medical Affairs )
Study ID Numbers:	SMA-09-03
Study First Received:	September 17, 2009
Last Updated:	January 22, 2010
ClinicalTrials.gov Identifier:	NCT00979615 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Alcon Research:

vasomotor rhinitis
chronic non-allergic rhinitis
VMR

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Rhinitis
Azelastine
Respiratory Tract Infections
Respiratory Tract Diseases
Sensory System Agents
Therapeutic Uses
Rhinitis, Vasomotor
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Otorhinolaryngologic Diseases

Histamine Agents
Anti-Asthmatic Agents
Enzyme Inhibitors
Anti-Allergic Agents
Olopatadine
Nose Diseases
Pharmacologic Actions
Lipoxygenase Inhibitors
Histamine Antagonists
Analgesics, Non-Narcotic
Autonomic Agents
Histamine H1 Antagonists
Peripheral Nervous System Agents
Antirheumatic Agents
Histamine H1 Antagonists, Non-Sedating

ClinicalTrials.gov processed this record on February 08, 2010