Phase 3 N=99 Randomized Quadruple-blind Treatment

Hypothalamic-Pituitary-Adrenal (HPA)-Axis Study in Pediatric Subjects With Perennial Allergic Rhinitis (PAR)

Allergic Rhinitis

Bottom Line

View on ClinicalTrials.gov: NCT01697956 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2015

Primary outcome: Primary: Change From Baseline (Expressed As A Ratio) In 24-Hr Serum Cortisol Weighted Mean Following 6 Weeks Of Treatment — 1.04; 1.10 ratio

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: BDP (Drug); Placebo (Drug)
Age: Pediatric · 6+ yrs
Sex: All
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Primary completion: Feb 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline (Expressed As A Ratio) In 24-Hr Serum Cortisol Weighted Mean Following 6 Weeks Of Treatment	1.04; 1.10	—
SECONDARY 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)	573.81; 45.60	—
SECONDARY Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC0-24) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP)	619.06; 200.80	—
SECONDARY Maximum Plasma Concentration (Cmax) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP)	142.68; 44.65	—
SECONDARY Time to Reach Maximum Plasma Concentration (Tmax) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP)	1.15; 1.26	—
SECONDARY Terminal Elimination Rate Constant (λz ) for Beclomethasone-17-monopropionate (17-BMP)	0.31	—
SECONDARY Terminal Elimination Half-life (t1/2) for Beclomethasone-17-monopropionate (17-BMP)	3.10	—
SECONDARY Participants With Treatment-Emergent Adverse Events (AEs)	22; 13; 0; 0; 2; 1	—
SECONDARY Participants With Shifts in Hematology Results From Normal at Screening to High or Low at End of Study	0; 1; 0; 0; 0; 4	—
SECONDARY Participants With Shifts in Serum Chemistry Results From Normal at Screening to High or Low at End of Study	0; 0; 0; 0; 0; 0	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01697956). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.