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A Study Evaluating the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Meda Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00740792
First received: August 22, 2008
Last updated: August 7, 2012
Last verified: August 2012
Results First Received: May 15, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Seasonal Allergic Rhinitis
Interventions: Drug: azelastine HCl/fluticasone propionate
Drug: azelastine Hcl
Drug: fluticasone propionate
Drug: placebo

  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
No text entered.

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
MP29-02 azelastine HCl/fluticasone propionate
Azelastine HCL active comparator of azelastine HCl
Fluticasone Propionate active comparator of fluticasone propionate
Placebo placebo control

Participant Flow:   Overall Study
    MP29-02     Azelastine HCL     Fluticasone Propionate     Placebo  
STARTED     193     194     189     200  
COMPLETED     183     186     180     190  
NOT COMPLETED     10     8     9     10  
Adverse Event                 3                 1                 1                 3  
Lack of Efficacy                 1                 1                 0                 3  
Lost to Follow-up                 2                 1                 0                 0  
Protocol Violation                 0                 1                 0                 2  
Withdrawal by Subject                 1                 1                 0                 0  
administrative                 3                 3                 8                 2  



  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.
No text entered.

Reporting Groups
  Description
MP29-02 azelastine HCl/fluticasone propionate
Azelastine HCL active comparator of azelastine HCl
Fluticasone Propionate active comparator of fluticasone propionate
Placebo placebo control
Total Total of all reporting groups

Baseline Measures
    MP29-02     Azelastine HCL     Fluticasone Propionate     Placebo     Total  
Number of Participants  
[units: participants]
  193     194     189     200     776  
Age  
[units: participants]
         
<=18 years     12     12     14     17     55  
Between 18 and 65 years     176     178     172     181     707  
>=65 years     5     4     3     2     14  
Age  
[units: years]
Mean ± Standard Deviation
  38.8  ± 14.1     38.2  ± 13.5     37.0  ± 13.6     37.2  ± 13.0     37.8  ± 13.6  
Gender  
[units: participants]
         
Female     126     128     121     119     494  
Male     67     66     68     81     282  
Region of Enrollment  
[units: participants]
         
United States     193     194     189     200     776  



  Outcome Measures
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1.  Primary:   Change From Baseline in 12 Hour Reflective Total Nasal Symptom Score (rTNSS)   [ Time Frame: day1 to 14 days ]

2.  Secondary:   Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS)   [ Time Frame: day 1 to14 ]

3.  Secondary:   Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)   [ Time Frame: day 1 to day 14 ]


  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: David Ginsberg,D.O.
Organization: Meda Pharmaceuticals
phone: 7325642364
e-mail: david.ginsberg@meda.us


No publications provided


Responsible Party: Meda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00740792     History of Changes
Other Study ID Numbers: MP4004
Study First Received: August 22, 2008
Results First Received: May 15, 2012
Last Updated: August 7, 2012
Health Authority: United States: Food and Drug Administration