Long Term Safety and Efficacy Trial of Beclomethasone Dipropionate - Hydrofluoroalkane (BDP-HFA) 320 Mcg in Allergic Rhinitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier:
NCT00988247
First received: September 30, 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, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Rhinitis, Allergic, Perennial
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 857 patients were screened and 775 patients were enrolled in the study and participated in the Run-in Period. Of the 775 enrolled patients, 529 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 21 day Run-in Period, participants self-administered a single-blind placebo nasal aerosol once daily in the morning and assessed and recorded their daily seasonal rhinitis symptoms to determine eligibility for randomization.

Reporting Groups
  Description
BDP HFA 320 µg/Day During the 30-week (or 52-week, depending upon investigator site) 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 30-week (or 52-week, depending upon investigator site) 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     418     111  
Safety Population     415 [1]   111 [1]
Intent to Treat Population     414 [2]   110 [2]
COMPLETED     335     85  
NOT COMPLETED     83     26  
Adverse Event                 17                 3  
Withdrawal by Subject                 44                 13  
Pregnancy                 1                 2  
Lost to Follow-up                 11                 2  
Protocol Violation                 4                 5  
Sponsor requested withdrawal                 3                 1  
Not specified                 3                 0  
[1] Participants who received at least 1 dose of study drug
[2] Participants who received at least 1 dose of study drug and had at least 1 post-baseline assessment



  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.
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Reporting Groups
  Description
BDP HFA 320 µg/Day During the 30-week (or 52-week, depending upon investigator site) 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 30-week (or 52-week, depending upon investigator site) 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]
  414     110     524  
Age [1]
[units: years]
Mean ± Standard Deviation
  37.4  ± 13.6     35.7  ± 12.9     37.1  ± 13.4  
Gender  
[units: participants]
     
Female     286     66     352  
Male     128     44     172  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     45     12     57  
Not Hispanic or Latino     369     98     467  
Unknown or Not Reported     0     0     0  
Race/Ethnicity, Customized [2]
[units: participants]
     
American Indian or Alaska Native     7     2     9  
Asian     13     1     14  
Native Hawaiian or Other Pacific Islander     3     0     3  
Black or African American     63     14     77  
White     341     97     438  
Unknown or Not Reported     1     0     1  
Body mass index  
[units: kg/m^2]
Mean ± Standard Deviation
  28.8  ± 6.7     28.4  ± 6.7     28.7  ± 6.7  
[1] Demographic data are provided for the Intent to Treat population.
[2] A participant may select more than one race type.



  Outcome Measures
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1.  Primary:   Change From Baseline in Average Subject-Assessed 24-Hour Reflective Total Nasal Symptom Score (rTNSS) up to 30 Weeks   [ Time Frame: Baseline (Days -6 to 0), Day 1 to Week 30 ]

2.  Secondary:   Change From Baseline in Average Subject-Assessed 24-Hour Instantaneous Total Nasal Symptom Score (iTNSS) up to 30 Weeks   [ Time Frame: Baseline (Days -6 to 0), Day 1 to Week 30 ]

3.  Secondary:   Change From Baseline in Average Subject-Assessed 24-Hour Reflective Total Nasal Symptom Score (rTNSS) up to 52 Weeks   [ Time Frame: Baseline (Days -6 to 0), Day 1 to Week 52 ]

4.  Secondary:   Change From Baseline in Average Subject-Assessed 24-Hour Instantaneous Total Nasal Symptom Score (iTNSS) up to 52 Weeks   [ Time Frame: Baseline (Days -6 to 0), Day 1 to Week 52 ]

5.  Secondary:   Change From Baseline to Week 30 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline   [ Time Frame: Day 0 (Baseline) and Week 30 ]

6.  Secondary:   Change From Baseline to Week 52 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline   [ Time Frame: Day 0 (Baseline) and Week 52 ]


  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:
Meltzer EO, Jacobs RL, LaForce CF, Kelley L, Dunbar SA, Tantry SK. Safety and Efficacy of Once Daily Treatment With beclomethasone dipropionate nasal aerosol in Subjects With Perennial Allergic Rhinitis. Allergy Asthma Proc (2012) (E-Pub)
Meltzer EO, Jacobs RL, LaForce CF, Dorinsky PM, Kelley L, Dunbar SA, Tantry SK. . BDP HFA Nasal Aerosol 320 µg Once Daily Is Safe and Effective in the Treatment of Nasal Symptoms Associated With Perennial Allergic Rhinitis. Ann Allergy Asthma Immunol 2011 (Supplement); 107(11):A118 - Poster presentation.
Gross GN, Settipane RA, Ford LB, Kelley L, Dunbar SA, Tantry SK, Dorinsky PM . Patient Satisfaction and Ease-of-Use of BDP HFA Nasal Aerosol Device in Subjects With Perennial Allergic Rhinitis. Ann Allergy Asthma Immunol 2011 (Supplement); 107(11):A119 - Poster presentation


Responsible Party: Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier: NCT00988247     History of Changes
Other Study ID Numbers: BDP-AR-303
Study First Received: September 30, 2009
Results First Received: April 23, 2012
Last Updated: April 23, 2012
Health Authority: United States: Food and Drug Administration