Hypothalamic-Pituitary-Adrenal (HPA)-Axis Study in Pediatric Subjects With Perennial Allergic Rhinitis (PAR)
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)
1 other identifier
interventional
99
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2012
Shorter than P25 for phase_3
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2012
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedFirst Posted
Study publicly available on registry
October 2, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedResults Posted
Study results publicly available
October 8, 2015
CompletedOctober 8, 2015
September 1, 2015
4 months
September 28, 2012
July 27, 2015
September 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline (Expressed As A Ratio) In 24-Hr Serum Cortisol Weighted Mean Following 6 Weeks Of Treatment
The serum cortisol weighted mean (0-t), calculated by dividing the area under the concentration-time curve (AUC) from time zero to the time of the last measurable value over the 24-hour period by the sample collection time interval, was determined for each participant at baseline and Week 6, and the ratio of Week 6 over baseline was derived.
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 (9)
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)
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)
Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC0-24) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP)
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)
Maximum Plasma Concentration (Cmax) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP)
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)
Time to Reach Maximum Plasma Concentration (Tmax) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP)
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)
Terminal Elimination Rate Constant (λz ) for Beclomethasone-17-monopropionate (17-BMP)
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)
- +4 more secondary outcomes
Study Arms (2)
BDP Nasal Aerosol 80 mcg/day
EXPERIMENTALBDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 42 day (6 week) Treatment Period.
Placebo Nasal Aerosol
PLACEBO COMPARATORParticipants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
Interventions
Beclomethasone dipropionate (BDP) 80 mcg/day (40 mcg/spray, 1 spray/nostril, once daily - total 2 sprays/day) as a nasal aerosol.
Placebo (1 spray/nostril, once daily - total 2 sprays/day) as a nasal aerosol.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Teva Investigational Site 10305
Long Beach, California, United States
Teva Investigational Site 10304
Stockbridge, Georgia, United States
Teva Investigational Site 10300
Plymouth, Minnesota, United States
Teva Investigational Site 10302
Normal Square, Pennsylvania, United States
Teva Investigational Site 10301
New Braunfels, Texas, United States
Teva Investigational Site 10303
San Antonio, Texas, United States
Related Publications (1)
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.
PMID: 26250771DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director, Clinical Research
- Organization
- Teva Branded Pharmaceutical Products, R&D Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Sudeesh K Tantry, Ph.D.
Teva Branded Pharmaceutical Products R&D
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2012
First Posted
October 2, 2012
Study Start
October 1, 2012
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
October 8, 2015
Results First Posted
October 8, 2015
Record last verified: 2015-09