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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01307319
Other study ID # BDP-AR-305
Secondary ID
Status Completed
Phase Phase 3
First received February 28, 2011
Last updated February 3, 2015
Start date March 2011
Est. completion date August 2011

Study information

Verified date February 2015
Source Teva Pharmaceutical Industries
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety and efficacy of an investigational nasal aerosol at two doses compared with placebo nasal aerosol in the treatment of seasonal allergic rhinitis in children (6-11 years of age).


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Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Drug:
BDP HFA
BDP (beclomethasone dipropionate) HFA (hydrofluoroalkane) nasal aerosol administered as a single actuation in each nostril daily for the 15 day treatment period. Each actuation contains either 40 or 80 mcg for a total daily dose of either 80 or 160 mcg depending upon the assigned treatment arm.
Placebo nasal aerosol
Placebo formulated as a nasal aerosol spray and administered as a single actuation in each nostril daily for the 15 day treatment period.

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Sponsors (1)

Lead Sponsor Collaborator
Teva Branded Pharmaceutical Products, R&D Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Reflective Total Nasal Symptom Score (rTNSS) During the Two Weeks of Treatment Reflective TNSS is an evaluation of symptom severity over the past 12 hours prior to the recording of the score. Participants (with assistance from parents/guardians/caregivers, as needed) assessed and recorded four nasal symptoms (runny nose, nasal congestion, nasal itching, and sneezing) twice daily (AM and PM) using the following scale:
0 = absent (no sign/symptom present)
1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated)
2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable)
3 = severe (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping) The total TNSS scale was 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms.
Baseline was defined as the average AM and PM subject-reported rTNSS over the 4 days prior to randomization.
Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Day 15 No
Secondary Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Instantaneous Total Nasal Symptom Score (iTNSS) During the Two Weeks of Treatment Instantaneous TNSS is an evaluation of symptom severity over the last 10 minutes prior to the recording of the score. Participants (with assistance from parents/guardians/caregivers, as needed) assessed and recorded four nasal symptoms (runny nose, nasal congestion, nasal itching, and sneezing) twice daily (AM and PM) using the following scale:
0 = absent (no sign/symptom present)
1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated)
2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable)
3 = severe (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping) The total TNSS scale was 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms.
Baseline was defined as the average AM and PM subject-reported iTNSS over the 4 days prior to randomization.
Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Day 15 No
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