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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:
ClinicalTrials.gov Identifier:
NCT00740792
First Posted: August 25, 2008
Last Update Posted: September 7, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Meda Pharmaceuticals
Results First Submitted: May 15, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, 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
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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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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



Responsible Party: Meda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00740792     History of Changes
Other Study ID Numbers: MP4004
First Submitted: August 22, 2008
First Posted: August 25, 2008
Results First Submitted: May 15, 2012
Results First Posted: September 7, 2012
Last Update Posted: September 7, 2012