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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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BDP Nasal Aerosol 80 mcg/day

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.

Group Type EXPERIMENTAL

BDP

Intervention Type DRUG

Beclomethasone dipropionate (BDP) 80 mcg/day (40 mcg/spray, 1 spray/nostril, once daily - total 2 sprays/day) as a nasal aerosol.

Placebo Nasal Aerosol

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo (1 spray/nostril, once daily - total 2 sprays/day) as a nasal aerosol.

Interventions

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BDP

Beclomethasone dipropionate (BDP) 80 mcg/day (40 mcg/spray, 1 spray/nostril, once daily - total 2 sprays/day) as a nasal aerosol.

Intervention Type DRUG

Placebo

Placebo (1 spray/nostril, once daily - total 2 sprays/day) as a nasal aerosol.

Intervention Type DRUG

Other Intervention Names

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QNASL® Beclomethasone dipropionate

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No