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

NCT00979615 | Completed Phase 4 Results

• 1 other identifier: SMA-09-03
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

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).

Conditions

Vasomotor Rhinitis

Keywords

vasomotor rhinitis; chronic non-allergic rhinitis; VMR

Outcome Measures

Primary Outcomes (1)

• Mean Change in 2-week rTNSS From Baseline

  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.

  2 week

Secondary Outcomes (4)

• Mean Change in Rhinorrhea Reflective Score

  2 week

• Mean Change Postnasal Drip Reflective Score

  2 Weeks

• Mean Change Nasal Congestion Reflective Score

  2 Weeks

• Mean Change in Sneezing Reflective Score

  2 Weeks

Study Arms (2)

1

EXPERIMENTAL

Olopatadine HCL Nasal Spray, 0.6%

Drug: Olopatadine HCL (Patanase) Nasal Spray, 0.6%

2

ACTIVE COMPARATOR

Azelastine HCl Nasal Spray, 137 mcg

Drug: Azelastine HCl (Astelin) Nasal Spray, 137 mcg

Interventions

Olopatadine HCL (Patanase) Nasal Spray, 0.6% DRUG

2 sprays/ nostril BID

1

Azelastine HCl (Astelin) Nasal Spray, 137 mcg DRUG

2 sprays/ nostril BID

2

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Contact Alcon Call Center For Trial Locations

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Rhinitis, Vasomotor

Interventions

Olopatadine Hydrochloride; Nasal Sprays; azelastine

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Dibenzoxepins; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Aerosols; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Maria J. Tort, PhD
• Organization: Alcon Research, Ltd.

Maria.Tort@alconlabs.com

(817) 302-5968

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 17, 2009
• First Posted: September 18, 2009
• Study Start: September 1, 2009
• Primary Completion: November 1, 2009
• Last Updated: May 10, 2011
• Results First Posted: May 10, 2011

Record last verified: 2011-04

Locations

US (1)