Study to Evaluate the Safety and Tolerability of a Nasal Spray in Patients With Chronic Allergic or Nonallergic Rhinitis

This study has been completed.
Sponsor:
Information provided by:
Meda Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00783432
First received: October 30, 2008
Last updated: October 1, 2009
Last verified: October 2009
Results First Received: December 29, 2008  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Chronic Allergic Rhinitis
Nonallergic Rhinitis
Interventions: Drug: Astepro Nasal Spray (0.1% azelastine hydrochloride)
Drug: Astelin Nasal Spray (0.1% azelastine hydrochloride)

  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 24 July 2006 and last observation 28 Dec 2007

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

Reporting Groups
  Description
Astepro Nasal Spray (0.1% azelastine hydrochloride)
Astelin Nasal Spray (0.1% azelastine hydrochloride)

Participant Flow:   Overall Study
    Astepro Nasal Spray     Astelin Nasal Spray  
STARTED     430 [1]   432 [1]
COMPLETED     345     354  
NOT COMPLETED     85     78  
Adverse Event                 22                 17  
Lack of Efficacy                 20                 21  
Lost to Follow-up                 11                 6  
Withdrawal by Subject                 23                 20  
subject moved                 3                 5  
Protocol Violation                 6                 9  
[1] This includes 2 subjects that received a randomization number but did not receive study drug



  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
Astepro Nasal Spray (0.1% azelastine hydrochloride)
Astelin Nasal Spray (0.1% azelastine hydrochloride)
Total Total of all reporting groups

Baseline Measures
    Astepro Nasal Spray     Astelin Nasal Spray     Total  
Number of Participants  
[units: participants]
  428     430     858  
Age  
[units: participants]
     
<=18 years     11     10     21  
Between 18 and 65 years     389     391     780  
>=65 years     28     29     57  
Age  
[units: years]
Mean ± Standard Deviation
  41.2  ± 14.95     41.3  ± 15.12     41.2  ± 15.03  
Gender  
[units: participants]
     
Female     221     236     457  
Male     207     194     401  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     8     16     24  
Native Hawaiian or Other Pacific Islander     1     0     1  
Black or African American     6     4     10  
White     410     405     815  
More than one race     0     0     0  
Unknown or Not Reported     3     5     8  
Region of Enrollment  
[units: participants]
     
Australia     40     39     79  
Europe     388     391     779  
Duration of Rhinitis  
[units: years]
Mean ± Standard Deviation
  10.5  ± 11.04     11.3  ± 10.85     10.9  ± 10.95  
Total Nasal Symptom Score (AM + PM) [1]
[units: units on a scale (0-3)]
Mean ± Standard Deviation
  9.69  ± 4.506     9.96  ± 4.725     9.82  ± 4.617  
[1] TNSS scale: 0=no symptoms, 1=mild symptoms, 2=moderate symptoms and 3 = severe symptoms scored twice daily such that the maximum daily score is 24.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants Reporting Adverse Events   [ Time Frame: 12 months ]

2.  Primary:   Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.   [ Time Frame: baseline and 12 months/ET ]

3.  Secondary:   Adult Mini-Rhinoconjuctivitis Quality of Life Questionnaire. Change From Baseline in RQLQ Score at Months 1,3,6,9 and 12/or Early Termination.   [ Time Frame: baseline, months 1,3,6,9 and 12/or early termination ]


  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: 732-564-2351
e-mail: wwheeler@medapharma.us


No publications provided


Responsible Party: Harry Sacks, MD, Vice President, Medical and Scientific Affairs
ClinicalTrials.gov Identifier: NCT00783432     History of Changes
Other Study ID Numbers: MP432
Study First Received: October 30, 2008
Results First Received: December 29, 2008
Last Updated: October 1, 2009
Health Authority: Bulgaria: Ministry of Health
Slovakia: State Institute for Drug Control
Australia: Department of Health and Ageing Therapeutic Goods Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United Kingdom: Medicines and Healthcare Products Regulatory Agency