A Safety and Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6-11 Years With Perennial Allergic Rhinitis (PAR).

NCT01451541 | Completed Phase 3 Results

• 1 other identifier: SEP060-306
• Study Type: interventional
• Target: 848
• Locations: 1 country
• Sites: 60

Brief Summary

This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety study of ciclesonide nasal aerosol 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

Outcome Measures

Primary Outcomes (1)

• The Change From Baseline in Average Daily Subject-reported AM and PM Reflective Total Nasal Symptom Scores (rTNSS) Averaged Weekly Over the First 6 Weeks of the Double-blind Treatment.

  TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

  Weeks 0-6

Secondary Outcomes (11)

• Change From Baseline in Average Daily Subject-reported AM and PM Instantaneous Total Nasal Symptom Scores (iTNSS) Averaged Weekly Over the First 6 Weeks of Double-blind Treatment

  Weeks 0 -6

• Change From Baseline in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Overall Score at the End of the First 6 Weeks of Double-blind Treatment

  Weeks 0 -6

• Change From Baseline in Daily Average Subject-reported AM and PM rTNSS Averaged Weekly Over the 12-week Double-blind Treatment Period

  Weeks 0 -12

• Change From Baseline in Daily Average Subject-reported AM and PM iTNSS Averaged Weekly Over the 12-week Double-blind Treatment Period

  Weeks 0 -12

• Change From Baseline in Daily Average Subject-reported AM iTNSS Averaged Over the First 6 Weeks of Double-blind Treatment

  Weeks 0 -6

Study Arms (3)

ciclesonide nasal aerosol 37mcg

ACTIVE COMPARATOR

ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily

Drug: Ciclesonide nasal aerosol 37 mcg

ciclesonide nasal aerosol 74 mcg

ACTIVE COMPARATOR

ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily

Drug: ciclesonide nasal aerosol 74 mcg

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Ciclesonide nasal aerosol 37 mcg DRUG

ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37

ciclesonide nasal aerosol 37mcg

ciclesonide nasal aerosol 74 mcg DRUG

ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg

ciclesonide nasal aerosol 74 mcg

Placebo DRUG

Placebo - one dose per nostril

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 (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 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, and animal dander) for a minimum of 1 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 1 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 12 months prior to 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 PAR, and the allergen must be present in the subject's environment throughout the study.
• Subject or parent/guardian must possess an educational level and degree of understanding of English that enables them to communicate suitably with the Investigator and study coordinator as well as accurately complete both the AR diary and PRQLQ

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 unhealed 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, within the 14 days preceding the screening visit.
• 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 or is likely to have one during the study.
• Has nonvaccinated exposure to or active infection with chickenpox or measles within the 21 days preceding the screening visit.
• Is a child or 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.
• 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:
• impaired hepatic function
• history of ocular disturbances, eg, glaucoma or posterior subcapsular cataracts or herpes simplex

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (60)

Burke Pharmaceutical Research

Hot Springs, Arkansas, 71913, United States

Location

Arkansas Pediatric Clinic

Little Rock, Arkansas, 72205, United States

Location

West Coast Clinical Trials, LLC

Costa Mesa, California, 92626, United States

Location

Premier Health Research Center

Downey, California, 90241, United States

Location

Allergy and Asthma Specialists Medical Group

Huntington Beach, California, 92647, United States

Location

Pediatric Care Medical Group

Huntington Beach, California, 92647, United States

Location

Allergy and Asthma Assoc of Southern CA

Mission Veijo, California, 92691, United States

Location

Center for Clinical Trials, LLC

Paramount, California, 90723, United States

Location

Allergy Associates Medical Group

San Diego, California, 92120, United States

Location

Allergy and Asthma Medical Group & Research Center

San Diego, California, 92123, United States

Location

Sansum Clinic

Santa Barbara, California, 93110, United States

Location

Colorado Allergy and Asthma Centers, PC

Centennial, Colorado, 80112, United States

Location

IMMUNOe International Research Centers

Centennial, Colorado, 80112, United States

Location

Storms Clinical Research Institute

Colorado Springs, Colorado, 80907, United States

Location

Ashtma and Allergy Associates

Pueblo, Colorado, 81001, United States

Location

DataQuest Medical Research, LLC

Lawerenceville, Georgia, 30045, United States

Location

Aeroallergy Research Labs of Savannah

Savannah, Georgia, 31406, United States

Location

Atlanta Allergy and Asthma Clinic

Stockbridge, Georgia, 30281, United States

Location

Clinical Research Atlanta

Stockton, Georgia, 30281, United States

Location

Sneeze, Wheeze, & Itch Associates, LLC

Normal, Illinois, 61761, United States

Location

College Park Family Care Center

Lenexa, Kansas, 66215, United States

Location

Family Allergy and Asthma Research Institute

Louisville, Kentucky, 40215, United States

Location

Gordon Raphael, MD

Bethesda, Maryland, 20814, United States

Location

Northeast Medical Research Associates Inc

North Dartmouth, Massachusetts, 02747, United States

Location

Respiratory Medicine Research Institute of Michigan, PLC

Ypsilanti, Michigan, 48197, United States

Location

Clinical Research Institute Inc

Plymouth, Minnesota, 55441, United States

Location

Clinical Research of the Ozarks

Warrensburg, Missouri, 64093, United States

Location

Clinical Research Group of Montana

Bozeman, Montana, 59718, United States

Location

The Asthma and Allergy Center, PC

Bellevue, Nebraska, 68123, United States

Location

Boys Town National Research Hospital

Boys Town, Nebraska, 68010, United States

Location

Atlantic Research Center LLC

Ocean City, New Jersey, 07712, United States

Location

Island Medical Research P.C.

Rockville Centre, New York, 11570, United States

Location

Allergy and Asthma Center of NC, PA

High Point, North Carolina, 27262, United States

Location

Catalyst Medical Center

Fargo, North Dakota, 58103, United States

Location

Sterling Research Group Ltd

Cincinnati, Ohio, 45246, United States

Location

Toledo Center for Clinical Research

Sylvania, Ohio, 43560, United States

Location

Allergy, Asthma & Clinical Research Center

Oklahoma City, Oklahoma, 73120, United States

Location

Amy Darter, MD

Oklahoma City, Oklahoma, 73131, United States

Location

Cyn3rgy Research

Gresham, Oregon, 97030, United States

Location

Baker Allergy Asthma and Dermatolgy Research Center, LLC

Lake Oswego, Oregon, 97035, United States

Location

Clinical Research Institute of Southern Oregon, PC

Medford, Oregon, 97504, United States

Location

Allergy Associates Research Center

Portland, Oregon, 97202, United States

Location

Valley Clinical Research Center

Bethlehem, Pennsylvania, 18020, United States

Location

Asthma and Allergy Research Associates

Upland, Pennsylvania, 19013, United States

Location

National Allergy, Ashtma, and Urticaria Centers of Charleston, PA

North Charleston, South Carolina, 29406, United States

Location

Isis Clinical Research LLC

Austin, Texas, 78731, United States

Location

Sirius Clinical Research

Austin, Texas, 787, United States

Location

TTS Research

Boerne, Texas, 78006, United States

Location

Pharmaceutical Research and Consulting, Inc.

Dallas, Texas, 75231, United States

Location

Western Sky Medical Research

El Paso, Texas, 79903, United States

Location

Kerrville Research Associates

Kerrville, Texas, 78028, United States

Location

Central Texas Health Research

New Braunfels, Texas, 78130, United States

Location

Sylvana Research Associates

San Antonio, Texas, 78229, United States

Location

Allergy and Asthma Research Institute

Waco, Texas, 76712, United States

Location

J. Lewis Research Inc.

Salt Lake City, Utah, 84109, United States

Location

J. Lewis Research Inc.

Salt Lake City, Utah, 84121, United States

Location

J. Lewis Research Inc.

South Jordan, Utah, 84095, United States

Location

PI-Coor Clinical Research

Burke, Virginia, 22015, United States

Location

Clinical Research Partners, LLC

Henrico, Virginia, 23233, United States

Location

ASTHMA, Inc.

Seattle, Washington, 98105, 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

1-866-503-6351

Study Officials

• Respiratory Medical Director, MD

  Sumitomo Pharma America, Inc.

  STUDY DIRECTOR

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: October 11, 2011
• First Posted: October 13, 2011
• Study Start: October 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 6, 2014
• Results First Posted: May 6, 2014

Record last verified: 2014-04

Locations

US (60)