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Study of an Investigational Nasal Aerosol or Placebo in Children (Ages 4 to 11) With Perennial Allergic Rhinitis (PAR)

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ClinicalTrials.gov Identifier: NCT01783548
Recruitment Status : Completed
First Posted : February 5, 2013
Results First Posted : October 12, 2015
Last Update Posted : October 12, 2015
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Allergic Rhinitis
Interventions: Drug: BDP Nasal Aerosol
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 770 subjects were screened. The 547 participants were randomly assigned to either BDP nasal aerosol (80 mcg/day) or placebo nasal aerosol in a 2:1 ratio.

Reporting Groups
  Description
BDP Nasal Aerosol 80 mcg/Day BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 12-week Treatment Period.
Placebo Nasal Aerosol Placebo nasal aerosol: Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 12-week Treatment Period.

Participant Flow:   Overall Study
    BDP Nasal Aerosol 80 mcg/Day   Placebo Nasal Aerosol
STARTED   362 [1]   185 [1] 
Full Analysis Set (FAS)   358   184 
COMPLETED   328   167 
NOT COMPLETED   34   18 
Adverse Event                8                4 
Withdrawal by Subject                11                8 
Non-compliance                4                0 
Protocol Violation                2                2 
Lost to Follow-up                8                3 
Lack of Efficacy                1                1 
[1] Randomized



  Baseline Characteristics

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.
Intent to treat population which included all randomized participants.

Reporting Groups
  Description
BDP Nasal Aerosol 80 mcg/Day BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 12-week Treatment Period.
Placebo Nasal Aerosol Placebo nasal aerosol: Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 12-week Treatment Period.
Total Total of all reporting groups

Baseline Measures
   BDP Nasal Aerosol 80 mcg/Day   Placebo Nasal Aerosol   Total 
Overall Participants Analyzed 
[Units: Participants]
 362   185   547 
Age 
[Units: Years]
Mean (Standard Deviation)
 8.0  (2.16)   8.0  (2.23)   8.0  (2.18) 
Age, Customized 
[Units: Participants]
     
4 to 5 years   62   31   93 
6 to 11 years   300   154   454 
Gender 
[Units: Participants]
     
Female   175   71   246 
Male   187   114   301 
Race/Ethnicity, Customized 
[Units: Participants]
     
White   272   145   417 
Black   65   25   90 
Other   25   15   40 
Race/Ethnicity, Customized 
[Units: Participants]
     
Hispanic or Latino   144   75   219 
Not Hispanic or Latino   217   110   327 
Unknown   1   0   1 
Weight 
[Units: Kg]
Mean (Standard Deviation)
 33.4  (13.40)   33.8  (13.24)   33.5  (13.34) 
Body Mass Index 
[Units: Kg/m^2]
Mean (Standard Deviation)
 18.6  (4.22)   18.9  (4.33)   18.7  (4.25) 


  Outcome Measures

1.  Primary:   Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Reflective Total Nasal Symptom Score (rTNSS) Over The First 6 Weeks Of Treatment In Subjects 6 To 11 Years Of Age   [ Time Frame: Baseline (Day -4 to Day 1 predose), Day 1 (postdose) to Week 6 ]

2.  Secondary:   Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Instantaneous Total Nasal Symptom Score (iTNSS) Over The First 6 Weeks Of Treatment In Subjects 6 To 11 Years Of Age   [ Time Frame: Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Week 6 ]

3.  Secondary:   Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Reflective Total Nasal Symptom Score (rTNSS) Over The First 6 Weeks Of Treatment In Subjects 4 To 11 Years Of Age   [ Time Frame: Baseline (Day -4 to Day 1 predose), Day 1 (postdose) to Week 6 ]

4.  Secondary:   Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Instantaneous Total Nasal Symptom Score (iTNSS) Over The First 6 Weeks Of Treatment In Subjects 4 To 11 Years Of Age   [ Time Frame: Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Week 6 ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.


  More Information

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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT01783548     History of Changes
Other Study ID Numbers: BDP-AR-306
First Submitted: January 31, 2013
First Posted: February 5, 2013
Results First Submitted: July 27, 2015
Results First Posted: October 12, 2015
Last Update Posted: October 12, 2015