Study in Adult and Adolescent Subjects With Seasonal Allergic Rhinitis (SAR)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier:
NCT01024608
First received: December 2, 2009
Last updated: April 23, 2012
Last verified: April 2012
Results First Received: April 23, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Seasonal Allergic Rhinitis
Hay Fever
Interventions: Drug: Beclomethasone dipropionate
Drug: Placebo Nasal Aerosol

  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
A total of 484 patients were screened and 463 patients were enrolled in the study and participated in the Run-in Period. Of the 463 enrolled patients, 340 were randomized to study treatment.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
During the 7 to 10 day Run-in Period, participants self-administered a single-blind placebo nasal aerosol once daily in the morning and assessed and recorded their seasonal rhinitis symptoms twice daily to determine eligibility for randomization.

Reporting Groups
  Description
BDP HFA 320 µg/Day During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
Placebo During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.

Participant Flow:   Overall Study
    BDP HFA 320 µg/Day     Placebo  
STARTED     169     171  
Intent to Treat Population     167 [1]   171 [1]
Safety Population     167 [2]   171 [2]
COMPLETED     165     167  
NOT COMPLETED     4     4  
Adverse Event                 1                 0  
Withdrawal by Subject                 1                 0  
Lost to Follow-up                 0                 1  
Protocol Violation                 0                 3  
Never received study treatment                 2                 0  
[1] Participants who received at least 1 dose of study drug and had at least 1 post-baseline assessment
[2] Participants who received at least 1 dose of 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
BDP HFA 320 µg/Day During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
Placebo During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
Total Total of all reporting groups

Baseline Measures
    BDP HFA 320 µg/Day     Placebo     Total  
Number of Participants  
[units: participants]
  167     171     338  
Age [1]
[units: years]
Mean ± Standard Deviation
  39.3  ± 13.4     38.0  ± 13.3     38.6  ± 13.3  
Gender  
[units: participants]
     
Female     113     97     210  
Male     54     74     128  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     52     49     101  
Not Hispanic or Latino     115     122     237  
Unknown or Not Reported     0     0     0  
Race/Ethnicity, Customized [2]
[units: participants]
     
American Indian or Alaska Native     1     1     2  
Asian     3     3     6  
Native Hawaiian or Other Pacific Islander     0     1     1  
Black or African American     23     26     49  
White     142     142     284  
[1] Demographic data are provided for the Intent to Treat population.
[2] A participant may select more than one race type.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Average Subject-Reported AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Two-week Treatment Period   [ Time Frame: Baseline (Days -3 to 0), and Days 1-15 ]

2.  Secondary:   Change From Baseline in Average Subject-Reported AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Two-week Treatment Period   [ Time Frame: Baseline (Days -3 to 0), and Days 1-15 ]

3.  Secondary:   Change From Baseline at Week 2 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline   [ Time Frame: Day 0 (Baseline), Day 15 ]

4.  Secondary:   Change From Baseline in AM and PM Subject-reported Reflective Ocular Symptom Score Over the 2-week Treatment Period   [ Time Frame: Baseline (Days -3 to 0), and Days 1-15 ]


  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: Director, Clinical Research
Organization: Teva Branded Pharmaceutical Products, R&D Inc.
phone: 215-591-3000
e-mail: ustevatrials@tevapharm.com


Publications of Results:
Van Bavel J, Ratner PH, Amar NJ, Hampel FC, Melchior A, Dunbar SA, Tantry SK and Dorinsky PM (2011). BDP HFA Nasal Aerosol 320 μg Once Daily Effectively Improves Ocular Symptoms Associated With Seasonal Allergic Rhinitis. Ann Allergy Asthma Immunol. 107(11):A118.
Van Bavel J, Dorinsky PM, Melchior A, Dunbar SA, and Tantry SK (2011). Nasal Symptom Relief and Improvement in Health-Related Quality of Life Following Treatment with BDP HFA Nasal Aerosol (320 mcg Once Daily) in Subjects with Seasonal Allergic Rhinitis. Allergy Asthma Proc. 32(4):330.
Van Bavel J, Hampel, FC, Ratner PH, Melchior A, Dunbar SA, Tantry SK and Dorinsky PM (2011). BDP HFA Nasal Aerosol Effectively Improves Nasal Symptom Relief and Health-Related Quality of Life (QOL) in Subjects with Seasonal Allergic Rhinitis (SAR). J Allergy Clin Immunol. 127(2):201.
Van Bavel J, Amar NJ, Melchior A, Dunbar SA, Tantry SK and Dorinsky PM (2010).BDP HFA Nasal Aerosol, 320 mcg Once Daily, is Safe and Effective in the Treatment of Nasal Symptoms Associated with Seasonal Allergic Rhinitis (SAR). Ann Allergy Asthma Immunol. 105(5):121.

Publications automatically indexed to this study:

Responsible Party: Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier: NCT01024608     History of Changes
Other Study ID Numbers: BDP-AR-301
Study First Received: December 2, 2009
Results First Received: April 23, 2012
Last Updated: April 23, 2012
Health Authority: United States: Food and Drug Administration