Loading clinical trials...

Safety Study of the Potential Inhibitory Effects of Ciclesonide Nasal Aerosol on the Hypothalamic-Pituitary-Adrenal Axis in Subjects 6-11 Years With Perennial Allergic Rhinitis | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Safety Study of the Potential Inhibitory Effects of Ciclesonide Nasal Aerosol on the Hypothalamic-Pituitary-Adrenal Axis in Subjects 6-11 Years With Perennial Allergic Rhinitis

A 6-Week Randomized, Double-blind, Placebo-controlled, Parallel Group, Safety Study of the Potential Inhibitory Effects of Ciclesonide Nasal Aerosol on the Hypothalamic-Pituitary-Adrenal (HPA) Axis in Subjects 6-11 Years With Perennial Allergic Rhinitis (PAR)

NCT01378429•Sumitomo Pharma America, Inc.

View on ClinicalTrials.gov

Summary

Detailed Description

This is a multicenter, randomized, double-blind, placebo-controlled, parallel group, safety study of the effects of ciclesonide nasal aerosol (74 mcg) on the HPA axis when administered once daily to male and premenarchal female subjects 6 to 11 years of age with a diagnosis of PAR. The study requires that subjects be domiciled during two 24- to 36-hour time periods for sample collection for serum and urinary free cortisol measurements, as well as PK evaluations (single \[predose\] time point during the first domiciled period, and 24-hour sampling during the second domiciled period).

Eligibility

Age

6 - 11 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Gives written informed consent (parent/legal guardian) and assent (when appropriate, from the child), including privacy authorization as well as adherence to concomitant medication withholding periods, prior to participation.
•Is a male or premenarchal female 6 to 11 years old and ≥ 20 kg at the screening visit.
•Is in general good health (defined as the absence of any clinically relevant abnormalities as determined by the investigator) based on screening physical examination and medical history.
•Has a history of PAR to a relevant perennial allergen (house dust mites, cockroaches, molds, animal dander) for a minimum of one year immediately preceding the study screening visit. The PAR must have been of sufficient severity to have required treatment (either continuous or intermittent) in the past and require treatment throughout the entire study period.
•Has a demonstrated sensitivity to at least one allergen known to induce PAR (house dust mites, cockroaches, molds, and animal dander) based on a documented result with a standard skin-prick test either within one year prior to the screening visit or performed at the screening visit. A positive test is defined as a wheal diameter at least 3 mm larger than the negative control wheal for the skin-prick test. The subject's positive allergen test must be consistent with the medical history of of PAR, and the allergen must be present in the subject's environment throughout the study.

Exclusion Criteria

•Has a history of physical findings of nasal pathology, including nasal polyps or other clinically significant respiratory tract malformations; recent nasal biopsy; nasal trauma; or nasal ulcers or perforations. Surgery and atrophic rhinitis or rhinitis medicamentosa are not permitted within the 120 days prior to the screening visit.
•Has evidence of infection, significant anatomic abnormality, ulceration of the mucosa, blood in the nose, or any other clinically relevant finding on nasal examination at the screening visit.
•Has nasal jewelry.
•Has participated in any investigational drug trial within the 30 days preceding the screening visit or is planning participation in another investigational drug trial at any time during this trial.
•Has a known hypersensitivity to any corticosteroid or any of the excipients in the formulation of ciclesonide.
•Has a history of a respiratory infection or disorder, including but not limited to bronchitis, pneumonia, influenza, and severe acute respiratory syndrome (SARS), within the 14 days preceding the screening visit.
•Has a history of adrenal insufficiency.
•Has active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of beta-agonists and any controller drugs (eg, theophylline, leukotriene antagonists); intermittent use (≤ 3 uses per week) of inhaled short-acting beta-agonists is acceptable. Use of short-acting beta-agonists for exercise-induced bronchospasm will be allowed.
•Is expecting to use any disallowed concomitant medications during the treatment period.
•Is, in the investigator's judgment, having a seasonal exacerbation at the time of the screening visit.
+15 more criteria

Locations (7)

West Coast Clinical Trials

Costa Mesa, California, United States

Clinical Research Atlanta

Stockbridge, Georgia, United States

Sneeze, Wheeze, & Itch Associates, LLC

Normal, Illinois, United States

Clinical Research Institute

Plymouth, Minnesota, United States

Western Sky Medical Research

El Paso, Texas, United States

Central Texas Health Research

New Braunfels, Texas, United States

Sylvania Research Associates

San Antonio, Texas, United States

Key Dates

Start Date

July 1, 2011

Primary Completion Date

November 1, 2011

Completion Date

November 1, 2011

Last Updated

May 26, 2014

Enrollment

ACTUAL participants

Conditions

Perennial Allergic RhinitisPAR

Interventions

ciclesonide nasal aerosol

DRUG

Placebo

DRUG

Dyadic Mindfulness for People With Parkinson's Disease and Their Caregivers

NCT06821230

MindfulnessCaregivers+5 more

View study

RECRUITINGNA

ACT Together: Implementing a Web-Based Program With Brief Coaching for Parents of Children With Disabilities in Pediatric Outpatient Clinics

NCT07360600

ParentsChildren With Disabilities+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 26, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety Study of the Potential Inhibitory Effects of Ciclesonide Nasal Aerosol on the Hypothalamic-Pituitary-Adrenal Axis in Subjects 6-11 Years With Perennial Allergic Rhinitis

Inclusion Criteria

Exclusion Criteria

Dyadic Mindfulness for People With Parkinson's Disease and Their Caregivers

ACT Together: Implementing a Web-Based Program With Brief Coaching for Parents of Children With Disabilities in Pediatric Outpatient Clinics

Deep Brain Stimulation Therapy in Movement Disorders

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

Chicago Parent Program for Foster and Kinship Caregivers