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

Teva Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Allergic Rhinitis

Treatments: Drug: Placebo; Drug: BDP

Study type: Interventional

Funder types: Industry

Identifiers

NCT01697956

BDP-AR-307

Details and patient eligibility

About

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.

Enrollment: 99 patients

Sex: All

Ages: 6 to 11 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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99 participants in 2 patient groups, including a placebo group

BDP Nasal Aerosol 80 mcg/day

Experimental group

Description:

BDP 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.

Treatment:

Drug: BDP

Placebo Nasal Aerosol

Placebo Comparator group

Description:

Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.

Treatment:

Drug: Placebo