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

NCT01378429 | Completed Phase 3 Results

• 1 other identifier: 060-308
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Perennial Allergic Rhinitis; PAR

Keywords

Perennial Allergic Rhinitis; PAR

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  Week 0 and 6

Secondary Outcomes (16)

• 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 AEs

  weeks 0-6

• Percentage of Subjects Experiencing AEs

  weeks 0-6

• Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation.

  weeks 0-6

Study Arms (2)

ciclesonide nasal aerosol

EXPERIMENTAL

ciclesonide nasal aerosol (74 mcg)

Drug: ciclesonide nasal aerosol

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ciclesonide nasal aerosol DRUG

ciclesonide nasal aerosol (74 mcg)

ciclesonide nasal aerosol

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Has nonvaccinated exposure to or active infection with chickenpox or measles within the 21 days preceding the screening visit.
• Has experienced significant blood loss within 60 days or loss of plasma within 72 hours prior to the screening visit or intends to undergo elective surgery within 30 days following end of study.
• Is a child or immediate relative of any clinical investigator or site personnel, even those who are not directly involved in this study.
• Resides in the same household as another subject who is participating in this study at the same time.
• Has any of the following conditions that are judged by the investigator to be clinically significant and/or to affect the subject's ability to participate in the clinical trial:

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (7)

West Coast Clinical Trials

Costa Mesa, California, 92626, United States

Location

Clinical Research Atlanta

Stockbridge, Georgia, 30281, United States

Location

Sneeze, Wheeze, & Itch Associates, LLC

Normal, Illinois, 61761, United States

Location

Clinical Research Institute

Plymouth, Minnesota, 55441, United States

Location

Western Sky Medical Research

El Paso, Texas, 79903, United States

Location

Central Texas Health Research

New Braunfels, Texas, 78130, United States

Location

Sylvania Research Associates

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Respiratory Medical Director
• Organization: Sunovion

866-503-6351

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2011
• First Posted: June 22, 2011
• Study Start: July 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: May 26, 2014
• Results First Posted: May 26, 2014

Record last verified: 2014-04

Locations

US (7)