Text Size

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
Results First Received: April 14, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, 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

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
September 9, 2009 - November 13, 2009

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Olopatadine HCL Olopatadine HCL Nasal Spray, 0.6%
Azelastine HCl Azelastine HCl Nasal Spray, 137 mcg

Participant Flow:   Overall Study
    Olopatadine HCL     Azelastine HCl  
STARTED     63     66  
COMPLETED     57     58  
NOT COMPLETED     6     8  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
Olopatadine HCL Olopatadine HCL Nasal Spray, 0.6%
Azelastine HCl Azelastine HCl Nasal Spray, 137 mcg
Total Total of all reporting groups

Baseline Measures
    Olopatadine HCL     Azelastine HCl     Total  
Number of Participants  
[units: participants]
 		  57     58     115  
Age  
[units: participants]
 		     
<=18 years     2     4     6  
Between 18 and 65 years     51     54     105  
>=65 years     4     0     4  
Gender  
[units: participants]
 		     
Female     39     46     85  
Male     18     12     30  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Change in 2-week rTNSS From Baseline   [ Time Frame: 2 week ]
  Show Outcome Measure 1

2.  Secondary:   Mean Change in Rhinorrhea Reflective Score   [ Time Frame: 2 week ]
  Show Outcome Measure 2

3.  Secondary:   Mean Change Postnasal Drip Reflective Score   [ Time Frame: 2 Weeks ]
  Show Outcome Measure 3

4.  Secondary:   Mean Change Nasal Congestion Reflective Score   [ Time Frame: 2 Weeks ]
  Show Outcome Measure 4

5.  Secondary:   Mean Change in Sneezing Reflective Score   [ Time Frame: 2 Weeks ]
  Hide Outcome Measure 5

Measure Type Secondary
Measure Title Mean Change in Sneezing Reflective Score
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Olopatadine HCL Olopatadine HCL Nasal Spray, 0.6%
Azelastine HCl Azelastine HCl Nasal Spray, 137 mcg

Measured Values
    Olopatadine HCL     Azelastine HCl  
Number of Participants Analyzed  
[units: participants]
 		  44     43  
Mean Change in Sneezing Reflective Score  
[units: Units on a scale]
Mean ± Standard Deviation 		  1.4  ± 0.9     1.7  ± 0.8  

No statistical analysis provided for Mean Change in Sneezing Reflective Score




  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

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.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Maria J. Tort, PhD
Organization: Alcon Research, Ltd.
phone: (817) 302-5968
e-mail: Maria.Tort@alconlabs.com


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