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

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

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

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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
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