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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00979615
First Posted: September 18, 2009
Last Update Posted: May 10, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Alcon Research
  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: Quadruple (Participant, Care Provider, 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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: September 17, 2009
First Posted: September 18, 2009
Results First Submitted: April 14, 2011
Results First Posted: May 10, 2011
Last Update Posted: May 10, 2011
Last Verified: April 2011

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
Olopatadine Hydrochloride
Azelastine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Lipoxygenase Inhibitors
Enzyme Inhibitors