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

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ClinicalTrials.gov Identifier: NCT00979615
Recruitment Status : Completed
First Posted : September 18, 2009
Results First Posted : May 10, 2011
Last Update Posted : May 10, 2011
Sponsor:
Information provided by:
Alcon Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Vasomotor Rhinitis
Interventions Drug: Olopatadine HCL (Patanase) Nasal Spray, 0.6%
Drug: Azelastine HCl (Astelin) Nasal Spray, 137 mcg
Enrollment 129
Recruitment Details September 9, 2009 - November 13, 2009
Pre-assignment Details  
Arm/Group Title Olopatadine HCL Azelastine HCl
Hide Arm/Group Description Olopatadine HCL Nasal Spray, 0.6% Azelastine HCl Nasal Spray, 137 mcg
Period Title: Overall Study
Started 63 66
Completed 57 58
Not Completed 6 8
Arm/Group Title Olopatadine HCL Azelastine HCl Total
Hide Arm/Group Description Olopatadine HCL Nasal Spray, 0.6% Azelastine HCl Nasal Spray, 137 mcg Total of all reporting groups
Overall Number of Baseline Participants 57 58 115
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 58 participants 115 participants
<=18 years
2
   3.5%
4
   6.9%
6
   5.2%
Between 18 and 65 years
51
  89.5%
54
  93.1%
105
  91.3%
>=65 years
4
   7.0%
0
   0.0%
4
   3.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 58 participants 115 participants
Female
39
  68.4%
46
  79.3%
85
  73.9%
Male
18
  31.6%
12
  20.7%
30
  26.1%
1.Primary Outcome
Title Mean Change in 2-week rTNSS From Baseline
Hide Description 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.
Time Frame 2 week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Olopatadine HCL Azelastine HCl
Hide Arm/Group Description:
Olopatadine HCL Nasal Spray, 0.6%
Azelastine HCl Nasal Spray, 137 mcg
Overall Number of Participants Analyzed 57 58
Mean (Standard Deviation)
Unit of Measure: Units on a scale
5.9  (3.0) 6.5  (2.3)
2.Secondary Outcome
Title Mean Change in Rhinorrhea Reflective Score
Hide Description 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.
Time Frame 2 week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Olopatadine HCL Azelastine HCl
Hide Arm/Group Description:
Olopatadine HCL Nasal Spray, 0.6%
Azelastine HCl Nasal Spray, 137 mcg
Overall Number of Participants Analyzed 44 43
Mean (Standard Deviation)
Unit of Measure: Units on a scale
1.5  (1.1) 1.3  (1.0)
3.Secondary Outcome
Title Mean Change Postnasal Drip Reflective Score
Hide Description 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.
Time Frame 2 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Olopatadine HCL Azelastine HCl
Hide Arm/Group Description:
Olopatadine HCL Nasal Spray, 0.6%
Azelastine HCl Nasal Spray, 137 mcg
Overall Number of Participants Analyzed 44 43
Mean (Standard Deviation)
Unit of Measure: Units on a scale
1.5  (1.2) 1.8  (0.9)
4.Secondary Outcome
Title Mean Change Nasal Congestion Reflective Score
Hide Description 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.
Time Frame 2 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Olopatadine HCL Azelastine HCl
Hide Arm/Group Description:
Olopatadine HCL Nasal Spray, 0.6%
Azelastine HCl Nasal Spray, 137 mcg
Overall Number of Participants Analyzed 44 43
Mean (Standard Deviation)
Unit of Measure: Units on a scale
1.4  (1.1) 1.7  (1.2)
5.Secondary Outcome
Title Mean Change in Sneezing Reflective Score
Hide Description 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.
Time Frame 2 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Olopatadine HCL Azelastine HCl
Hide Arm/Group Description:
Olopatadine HCL Nasal Spray, 0.6%
Azelastine HCl Nasal Spray, 137 mcg
Overall Number of Participants Analyzed 44 43
Mean (Standard Deviation)
Unit of Measure: Units on a scale
1.4  (0.9) 1.7  (0.8)
Time Frame Two weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Olopatadine HCL Azelastine HCl
Hide Arm/Group Description Olopatadine HCL Nasal Spray, 0.6% Azelastine HCl Nasal Spray, 137 mcg
All-Cause Mortality
Olopatadine HCL Azelastine HCl
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Olopatadine HCL Azelastine HCl
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/63 (0.00%)      0/66 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Olopatadine HCL Azelastine HCl
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/63 (7.94%)      9/66 (13.64%)    
Gastrointestinal disorders     
Taste Disturbance  1  3/63 (4.76%)  3 6/66 (9.09%)  6
Respiratory, thoracic and mediastinal disorders     
Nose Bleeds  1  2/63 (3.17%)  3 3/66 (4.55%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA LLT
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Maria J. Tort, PhD
Organization: Alcon Research, Ltd.
Phone: (817) 302-5968
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