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)

Sumitomo Pharma America, Inc.7 sites in 1 country89 target enrollmentJuly 2011

ConditionsPerennial Allergic Rhinitis PAR

Interventionsciclesonide nasal aerosol Placebo

Drugsciclesonide nasal aerosol Placebo

Overview

Phase: Phase 3
Intervention: ciclesonide nasal aerosol
Conditions: Perennial Allergic Rhinitis
Sponsor: Sumitomo Pharma America, Inc.
Enrollment: 89
Locations: 7
Primary Endpoint: The Change in Serum Cortisol Area Under the Curve (AUC) From Time 0 to 24 Hours (0-24), Calculated Using a Trapezoidal Rule, From Baseline to the End of the 6 Week Treatment Period
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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).

Registry

clinicaltrials.gov

Start Date

July 2011

End Date

November 2011

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sumitomo Pharma America, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

ciclesonide nasal aerosol

ciclesonide nasal aerosol (74 mcg)

Intervention: ciclesonide nasal aerosol

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

The Change in Serum Cortisol Area Under the Curve (AUC) From Time 0 to 24 Hours (0-24), Calculated Using a Trapezoidal Rule, From Baseline to the End of the 6 Week Treatment Period

Time Frame: Week 0 and 6

Area under the concentration-time curve from time 0 to 24 hours \[AUC(0-24h)\]. Timepoints at which data were collected: 0, 2, 4, 8, 12, 16, and 24 at week 0 and 6.

Secondary Outcomes

Change From Baseline in Urinary Free Cortisol-Corrected for Urine Creatinine(weeks 0-6)
Change From Baseline in Urinary Free Cortisol-Uncorrected for Urine Creatinine(weeks 0-6)
Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation.(weeks 0-6)
Maximum Observed Concentration(Week 6)
Change From Baseline in Averaged Daily Subject-reported AM and PM Reflective TNSS Averaged Over the 6 Weeks of Double-blind Treatment(weeks 0-6)
Percentage of Subjects Experiencing AEs(weeks 0-6)
Apparent Volume of Distribution (Vz/F)(Week 6)
Number of Devices With Actuation Consistency, Where Actuation Consistency is Defined as a Dose Indicator Count Within ± 20% of the Subject Self-report of Study Medication Administration(weeks 0-6)
Time to the Occurrence of Cmax(Week 6)
Terminal Half Life (t1/2)(Weeks 6)
Apparent Clearance of the Drug (CL/F)(Week 6)
Ratio (Percentage) of the Number of Correct Advances of the Dose Indicator to the Number of Expected Advances Based on Subject Self-report of Study Medication Administration Plus Extra Non-nasal Actuations(weeks 0-6)
Percentage of Devices With Actuation Consistency, Where Actuation Consistency is Defined as a Dose Indicator Count Within ± 20% of the Subject Self-report of Study Medication Administration(weeks 0-6)
Number of Subjects Experiencing AEs(weeks 0-6)
Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation.(weeks 0-6)
AUC(0-24h)(Week 6)