Completed

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)

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What is being tested

BDP

+ Placebo

Drug
Who is being recruted

Hypersensitivity+6

+ Hypersensitivity, Immediate

+ Immune System Diseases

From 6 to 11 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: October 2012
See protocol details

Summary

Principal SponsorTeva Branded Pharmaceutical Products R&D, Inc.
Last updated: October 8, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01697956
Principal SponsorTeva Branded Pharmaceutical Products R&D, Inc.
Last updated: October 8, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

99 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 6 to 11 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

HypersensitivityHypersensitivity, ImmediateImmune System DiseasesNose DiseasesOtorhinolaryngologic DiseasesRespiratory HypersensitivityRespiratory Tract DiseasesRhinitisRhinitis, Allergic

Criteria

5 inclusion criteria required to participate
A documented history of PAR to a relevant perennial allergen for a minimum of 12 months
General good health
Informed consent/(assent - if applicable)
Male or female subjects 6-11 years of age
Show More Criteria
9 exclusion criteria prevent from participating
A known hypersensitivity to any corticosteroid or any of the excipients in the study medication formulation
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
History of a respiratory infection or disorder within the 14 days preceding the Screening Visit 1 (SV1)
History of physical findings of nasal pathology, including nasal polyps or other clinically significant respiratory tract malformations
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
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 II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 6 locations

Teva Investigational Site 10305

Long Beach, United StatesOpen Teva Investigational Site 10305 in Google Maps

Teva Investigational Site 10304

Stockbridge, United States

Teva Investigational Site 10300

Plymouth, United States

Teva Investigational Site 10302

Normal Square, United States
Completed6 Study Centers