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A Study to Evaluate 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:
NCT00651118
First received: March 28, 2008
Last updated: August 27, 2012
Last verified: August 2012
Results First Received: May 10, 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: Placebo
Drug: azelastine Hcl
Drug: azelastineHcl / fluticasone propionate
Drug: fluticasone propionate

  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
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Reporting Groups
  Description
MP29-02 MP29-02(fluticasone propionate 50 mcg / azelastine HCl 137 mcg) nasal spray
Fluticasone Propionate fluticasone propionate nasal spray
Azelastine HCl azelastine HCl nasal spray nasal spray
Placebo placebo nasal spray

Participant Flow:   Overall Study
    MP29-02     Fluticasone Propionate     Azelastine HCl     Placebo  
STARTED     207     207     208     210  
COMPLETED     198     200     197     203  
NOT COMPLETED     9     7     11     7  
Adverse Event                 4                 0                 1                 1  
Protocol Violation                 2                 2                 6                 2  
Lost to Follow-up                 2                 0                 1                 2  
administrative                 1                 4                 2                 1  
Withdrawal by Subject                 0                 1                 1                 1  



  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
MP29-02 MP29-02(fluticasone propionate 50 mcg / azelastine HCl 137 mcg) nasal spray
Fluticasone Propionate fluticasone propionate nasal spray
Azelastine HCl azelastine HCl nasal spray nasal spray
Placebo placebo nasal spray
Total Total of all reporting groups

Baseline Measures
    MP29-02     Fluticasone Propionate     Azelastine HCl     Placebo     Total  
Number of Participants  
[units: participants]
  207     207     208     210     832  
Age  
[units: participants]
         
<=18 years     19     15     28     36     98  
Between 18 and 65 years     183     185     172     166     706  
>=65 years     5     7     8     8     28  
Age  
[units: years]
Mean ± Standard Deviation
  37.3  ± 14.1     38.6  ± 14.1     36.2  ± 14.6     37.3  ± 16.0     37.3  ± 14.7  
Gender  
[units: participants]
         
Female     142     127     130     133     532  
Male     65     80     78     77     300  
Region of Enrollment  
[units: participants]
         
United States     207     207     208     210     832  



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

2.  Secondary:   Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS)   [ Time Frame: day 1 to day 14 ]

3.  Secondary:   Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at the End of 14 Days   [ 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,..
Organization: Meda Pharmaceutical
phone: 732 564 2364
e-mail: david.ginsberg@meda.us


No publications provided


Responsible Party: Meda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00651118     History of Changes
Other Study ID Numbers: MP4002
Study First Received: March 28, 2008
Results First Received: May 10, 2012
Last Updated: August 27, 2012
Health Authority: United States: Food and Drug Administration