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

This study has been completed.

Sponsor:

Information provided by:

Alcon Research

ClinicalTrials.gov Identifier:

NCT00979615

First received: September 17, 2009

Last updated: April 14, 2011

Last verified: April 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	September 17, 2009
Last Updated Date	April 14, 2011
Start Date ^ICMJE	September 2009
Primary Completion Date	November 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 14, 2011)	Mean Change in 2-week rTNSS From Baseline [ Time Frame: 2 week ] [ Designated as safety issue: No ] Change from baseline after 2 weeks in responses to patient-completed diaries for reflective Total Nasal VMR Symptom Scores (rTVSS). TVSS is composed of 4 individual assessments, which included nasal congestion, rhinorrhea, post nasal drip and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are totaled for a composite score (TVSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication.
Original Primary Outcome Measures ^ICMJE (submitted: September 17, 2009)	Total Nasal VMR Symptoms Score [ Time Frame: 2 week ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT00979615 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 14, 2011)	Mean Change in Rhinorrhea Reflective Score [ Time Frame: 2 week ] [ Designated as safety issue: No ] Change from baseline after 2 weeks in responses to patient-completed diaries for reflective Total Nasal VMR Symptom Scores (rTVSS). TVSS is composed of 4 individual assessments, which included nasal congestion, rhinorrhea, post nasal drip and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are totaled for a composite score (TVSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication. Mean Change Postnasal Drip Reflective Score [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ] Change from baseline after 2 weeks in responses to patient-completed diaries for reflective Total Nasal VMR Symptom Scores (rTVSS). TVSS is composed of 4 individual assessments, which included nasal congestion, rhinorrhea, post nasal drip and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are totaled for a composite score (TVSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication. Mean Change Nasal Congestion Reflective Score [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ] Change from baseline after 2 weeks in responses to patient-completed diaries for reflective Total Nasal VMR Symptom Scores (rTVSS). TVSS is composed of 4 individual assessments, which included nasal congestion, rhinorrhea, post nasal drip and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are totaled for a composite score (TVSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication. Mean Change in Sneezing Reflective Score [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ] Change from baseline after 2 weeks in responses to patient-completed diaries for reflective Total Nasal VMR Symptom Scores (rTVSS). TVSS is composed of 4 individual assessments, which included nasal congestion, rhinorrhea, post nasal drip and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are totaled for a composite score (TVSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication.
Original Secondary Outcome Measures ^ICMJE (submitted: September 17, 2009)	Individual symptom severity scores [ Time Frame: 2 week ] [ Designated as safety issue: No ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy of Olopatadine 0.6% and Azelastine 137 Mcg in Vasomotor Rhinitis
Official Title ^ICMJE	Not Provided
Brief Summary	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).
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Vasomotor Rhinitis
Intervention ^ICMJE	Drug: Olopatadine HCL (Patanase) Nasal Spray, 0.6% 2 sprays/ nostril BID Drug: Azelastine HCl (Astelin) Nasal Spray, 137 mcg 2 sprays/ nostril BID
Study Arm (s)	Experimental: 1 Olopatadine HCL Nasal Spray, 0.6% Intervention: Drug: Olopatadine HCL (Patanase) Nasal Spray, 0.6% Active Comparator: 2 Azelastine HCl Nasal Spray, 137 mcg Intervention: Drug: Azelastine HCl (Astelin) Nasal Spray, 137 mcg
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	129
Completion Date	Not Provided
Primary Completion Date	November 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	12 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00979615
Other Study ID Numbers ^ICMJE	SMA-09-03
Has Data Monitoring Committee	Not Provided
Responsible Party	Maria Tort, PhD, Manager, Global Medical Affairs, Alcon Research Ltd
Study Sponsor ^ICMJE	Alcon Research
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Alcon Research
Verification Date	April 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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