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A Study to Evaluate the Safety and Efficacy of a Nasal Spray to Treat Children With Perennial Allergic Rhinitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Meda Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01018862
First received: November 24, 2009
Last updated: May 10, 2012
Last verified: May 2012
History of Changes
Results First Received: March 22, 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: Perennial Allergic Rhinitis
Interventions: Drug: Azelastine hydrochloride nasal spray 0.15%
Drug: Azelastine hydrochloride nasal spray 0.10%
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
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Reporting Groups
  Description
MP03-36 (0.15% Solution) 822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
MP03-33 (0.10% Solution) 548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
Placebo 0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks

Participant Flow:   Overall Study
    MP03-36 (0.15% Solution)     MP03-33 (0.10% Solution)     Placebo  
STARTED     161     166     162  
COMPLETED     148     156     146  
NOT COMPLETED     13     10     16  
Adverse Event                 2                 0                 6  
Lack of Efficacy                 1                 0                 2  
Lost to Follow-up                 3                 1                 0  
Protocol Violation                 1                 3                 3  
Withdrawal by Subject                 1                 2                 1  
administrative problems                 5                 4                 4  



  Baseline Characteristics
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Reporting Groups
  Description
MP03-36 (0.15% Solution) 822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
MP03-33 (0.10% Solution) 548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
Placebo 0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
Total Total of all reporting groups

Baseline Measures
    MP03-36 (0.15% Solution)     MP03-33 (0.10% Solution)     Placebo     Total  
Number of Participants  
[units: participants]
 		  161     166     162     489  
Age  
[units: participants]
 		       
<=18 years     161     166     162     489  
Between 18 and 65 years     0     0     0     0  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  8.8  ± 2.6     8.8  ± 2.7     8.7  ± 2.8     8.8  ± 2.7  
Gender  
[units: participants]
 		       
Female     74     65     69     208  
Male     87     101     93     281  
Region of Enrollment  
[units: participants]
 		       
United States     161     166     162     489  



  Outcome Measures
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1.  Primary:   Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (TNSS) for the Entire 28-day Study Period Compared to Placebo   [ Time Frame: baseline to 28 Days ]
  Show Outcome Measure 1

2.  Secondary:   Change From Baseline in the Instantaneous Total Nasal Symptoms Score (TNSS) for the Entire 28-day Study Period Compared to Placebo   [ Time Frame: baseline to 28 days ]
  Show Outcome Measure 2

3.  Secondary:   Change From Baseline in 12-hour Reflective Total Ocular Symptoms Score (TOSS) and Instantaneous Total Ocular Symptoms Score (TOSS) for the Entire 28-day Study Period Compared to Placebo   [ Time Frame: baseline to 28 days ]
  Show Outcome Measure 3

4.  Secondary:   Change From Baseline to Visit 4 in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Compared to Placebo   [ Time Frame: baseline to 28 Days ]
  Show Outcome Measure 4


  Serious Adverse Events
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  Other Adverse Events
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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.


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
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Results Point of Contact:  
Name/Title: Sr.Director Medical Scientific Affairs
Organization: Meda Pharmaceuticals Inc
phone: 732 564 2200
e-mail: David.ginsberg@meda.us


No publications provided


Responsible Party: Meda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01018862     History of Changes
Other Study ID Numbers: MP441
Study First Received: November 24, 2009
Results First Received: March 22, 2012
Last Updated: May 10, 2012
Health Authority: United States: Food and Drug Administration