Clinical trial NCT01697956: Hypothalamic-Pituitary-Adrenal (HPA)-Axis Study in Pediatric Subjects With Perennial Allergic Rhinitis (PAR)
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 6-Week Study Designed to Investigate the Effects of BDP Nasal Aerosol on the Hypothalamic-Pituitary-Adrenal (HPA)-Axis in Pediatric Subjects (6 to 11 Years of Age) With Perennial Allergic Rhinitis (PAR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergic Rhinitis
Keywords: Pediatric Subjects
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2012-10-02
Enrollment: 99
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effect of 6 weeks of treatment with beclomethasone dipropionate (BDP) nasal aerosol versus placebo on HPA-axis function, as assessed by 24-hour serum cortisol weighted mean, and to evaluate the safety and tolerability of BDP nasal aerosol, in subjects 6 to 11 years of age with perennial allergic rhinitis.


Eligibility criteria: Inclusion Criteria:

* Informed consent/(assent - if applicable)
* Male or female subjects 6-11 years of age
* General good health
* A documented history of PAR to a relevant perennial allergen for a minimum of 12 months
* Other criteria apply

Exclusion Criteria:

* Pregnancy, nursing, or plans to become pregnant or donate gametes
* Participation in any investigational drug study within the 30 days preceding the Screening Visit 1 (SV1)
* Previous participation in a BDP nasal aerosol study as a randomized subject
* A known hypersensitivity to any corticosteroid or any of the excipients in the study medication formulation
* History of physical findings of nasal pathology, including nasal polyps or other clinically significant respiratory tract malformations
* History of a respiratory infection or disorder within the 14 days preceding the Screening Visit 1 (SV1)
* Use of any prohibited concomitant medications within the prescribed (per protocol) withdrawal periods prior to the Screening Visit 1 (SV1)
* Other criteria apply
* Current smoker or current user of tobacco products at any time during the study; history of smoking or use of tobacco products within the past year

Primary outcomes:
measure: Change From Baseline (Expressed As A Ratio) In 24-Hr Serum Cortisol Weighted Mean Following 6 Weeks Of Treatment
timeFrame: Baseline (Day 1, -24, -22, -20, -16, -12, -8, and 0 hours prior to study medication), End of Treatment (Day 43, (Immediately prior to study medication administration (Hour 0) and at 2, 4, 8, 12, 16, and 24 hours after study medication administration)
Secondary outcomes:
measure: Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (AUC0-t ) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP)
timeFrame: Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration)
measure: Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC0-24) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP)
timeFrame: Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration)
measure: Maximum Plasma Concentration (Cmax) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP)
timeFrame: Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration)
measure: Time to Reach Maximum Plasma Concentration (Tmax) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP)
timeFrame: Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration)
measure: Terminal Elimination Rate Constant (λz ) for Beclomethasone-17-monopropionate (17-BMP)
timeFrame: Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration)
measure: Terminal Elimination Half-life (t1/2) for Beclomethasone-17-monopropionate (17-BMP)
timeFrame: Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration)
measure: Participants With Treatment-Emergent Adverse Events (AEs)
timeFrame: Day 1- week 10
measure: Participants With Shifts in Hematology Results From Normal at Screening to High or Low at End of Study
timeFrame: Screening (Day -21 to -7), End of Study (Day 42)
measure: Participants With Shifts in Serum Chemistry Results From Normal at Screening to High or Low at End of Study
timeFrame: Screening (Day -21 to -7), End of Study (Day 42)
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Teva Investigational Site 10305
state: California
city: Stockbridge
country: United States
facility: Teva Investigational Site 10304
state: Georgia
city: Plymouth
country: United States
facility: Teva Investigational Site 10300
state: Minnesota
city: Normal
country: United States
facility: Teva Investigational Site 10302
state: Pennsylvania
city: New Braunfels
country: United States
facility: Teva Investigational Site 10301
state: Texas
city: San Antonio
country: United States
facility: Teva Investigational Site 10303
state: Texas
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D
name: Sudeesh K Tantry, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hampel FC Jr, Nayak NA, Segall N, Small CJ, Li J, Tantry SK. No hypothalamic-pituitary-adrenal function effect with beclomethasone dipropionate nasal aerosol, based on 24-hour serum cortisol in pediatric allergic rhinitis. Ann Allergy Asthma Immunol. 2015 Aug;115(2):137-42. doi: 10.1016/j.anai.2015.05.019.