A Study to Evaluate the Safety and Efficacy of Two Nasal Sprays to Treat Seasonal Allergies

This study has been completed.
Sponsor:
Information provided by:
Meda Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00720278
First received: July 21, 2008
Last updated: February 19, 2010
Last verified: February 2010
Results First Received: September 23, 2009  
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: 0.15% azelastine hydrochloride 1644 mcg daily
Drug: 0.1% azelastine hydrochloride 1096 mcg daily
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
First observation: 14 Aug 2007 Last observation: 19 Nov 2007

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects participated in a 7 day screening period to Identify appropriate subjects based on symptom scores.

Reporting Groups
  Description
Placebo Placebo Nasal Spray taken 2 sprays per nostril twice a day for 14 days
Astepro 0.1% 0.1% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
Astepro 0.15% 0.15% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days

Participant Flow:   Overall Study
    Placebo     Astepro 0.1%     Astepro 0.15%  
STARTED     178 [1]   170 [1]   178 [1]
COMPLETED     171     166     172  
NOT COMPLETED     7     4     6  
Adverse Event                 5                 3                 4  
Withdrawal by Subject                 0                 1                 0  
Lost to Follow-up                 0                 0                 1  
Non-compliance                 1                 0                 0  
eligibility criteria violation                 1                 0                 1  
[1] 1 subject was randomized in error



  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
Placebo Placebo Nasal Spray taken 2 sprays per nostril twice a day for 14 days
Astepro 0.1% 0.1% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
Astepro 0.15% 0.15% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
Total Total of all reporting groups

Baseline Measures
    Placebo     Astepro 0.1%     Astepro 0.15%     Total  
Number of Participants  
[units: participants]
  177     169     177     523  
Age [1]
[units: participants]
       
<=18 years     24     16     16     56  
Between 18 and 65 years     148     151     156     455  
>=65 years     5     2     5     12  
Age [1]
[units: years]
Mean ± Standard Deviation
  36.9  ± 14.27     35.4  ± 13.74     37.7  ± 14.64     36.7  ± 14.23  
Gender [1]
[units: participants]
       
Female     116     111     107     334  
Male     61     58     70     189  
Region of Enrollment [1]
[units: participants]
       
United States     177     169     177     523  
[1] Number of participants based on ITT population



  Outcome Measures
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1.  Primary:   Change From Baseline in 12-hour Reflective Total Nasal Symptom Score(rTNSS)for the Entire 14-day Study Period Compared to Placebo   [ Time Frame: baseline and 14 days ]

2.  Secondary:   Change From Baseline in Instantaneous Total Nasal Symptom Score for the Entire 14-day Study Period Compared to Placebo   [ Time Frame: baseline and 14 Days ]

3.  Secondary:   Change From Baseline in the 12-hour Reflective Secondary Symptom Complex Score for the Entire 14-day Study Period Compared to Placebo   [ Time Frame: baseline and 14 days ]

4.  Secondary:   Change From Baseline to Day 14 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Patients 18 Years of Age and Older   [ Time Frame: baseline and 14 days ]

5.  Secondary:   Change From Baseline on Direct Visual Nasal Exams   [ Time Frame: 14 days ]


  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
No text entered.


  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: William Wheeler, PhD
Organization: Meda Pharmaceuticals
phone: 732-564-2393
e-mail: WWheeler@medapharma.us


No publications provided


Responsible Party: Harry Sacks, MD Vice President, Medical and Scientific Affairs, Med Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00720278     History of Changes
Other Study ID Numbers: MP438
Study First Received: July 21, 2008
Results First Received: September 23, 2009
Last Updated: February 19, 2010
Health Authority: United States: Food and Drug Administration