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
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 129
Study Start Date: September 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Olopatadine HCL Nasal Spray, 0.6%
Drug: Olopatadine HCL (Patanase) Nasal Spray, 0.6%
2 sprays/ nostril BID
Active Comparator: 2
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: 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

Keywords provided by Alcon Research:
vasomotor rhinitis
chronic non-allergic rhinitis
VMR

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Vasomotor
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Azelastine
Olopatadine
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Lipoxygenase Inhibitors
Enzyme Inhibitors
Anti-Allergic Agents
Therapeutic Uses
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 26, 2014