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

Information source: Sunovion
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Seasonal Allergic Rhinitis

Intervention: Ciclesonide nasal aerosol 37 mcg (Drug); ciclesonide nasal aerosol 74 mcg (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Sunovion

Official(s) and/or principal investigator(s):
Respiratory Medical Director, MD, Study Director, Affiliation: Sunovion

Summary

This is a 2-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-old diagnosed with SAR.

Clinical Details

Official title: A 2-Week Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Safety and Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6 to 11 Years With Seasonal Allergic Rhinitis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change From Baseline in Average Daily Subject Reported AM and PM Reflective Total Nasal Symptom Scores (rTNSS) Over the 2-week Double-blind Treatment Period

Secondary outcome:

Change From Baseline in Average Daily Subject-reported AM and PM Instantaneous Total Nasal Symptom Scores (iTNSS) Over the 2-week Double-blind Treatment Period

Change From Baseline in Average Daily Subject-reported AM and PM Reflective Total Ocular Symptom Scores (rTOSS) Over the 2-week Double-blind Treatment Period.

Change From Baseline in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Overall Score at the End of the Double-blind Treatment Period.

Change From Baseline in Average Daily Subject Reported AM Instantaneous Total Nasal Symptom Scores (iTNSS) Over the 2-week Double-blind Treatment Period

Change From Baseline in Average Daily Subject-reported AM and PM Instantaneous Total Ocular Symptom Scores (iTOSS) Over the 2-week Double-blind Treatment Period.

Time to Maximal Effect in the AM and PM Reflective Total Nasal Symptom Scores (rTNSS) Over the 2-week Double-blind Treatment Period

Number of Subjects Experiencing Treatment-emergent AEs

Percentage of Subjects Experiencing Treatment-emergent AEs

Treatment-emergent AEs Causing Study Medication Discontinuation

Number of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation

Percentage of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation

Detailed description: This is a 2-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-old diagnosed with SAR. This study will consist of the following: Screening, Single-blind Placebo Run-in period, Double-blind Treatment period (during this period, subjects will be randomized to double-blind treatment with either ciclesonide nasal aerosol 37 mcg or 74 mcg or placebo for 2 weeks of treatment) and Follow-up. The total duration of subject participation will be approximately 2 months.

Eligibility

Minimum age: 6 Years. Maximum age: 11 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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.

- 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 SAR to any relevant dominant seasonal allergen for a minimum of one

to two years immediately preceding the study Screening Visit. The SAR must have been of sufficient severity to have required treatment (either continuous or intermittent) in the past and is expected to require treatment throughout the entire study period.

- Has a demonstrated sensitivity to a relevant dominant seasonal allergen known to

induce SAR based on a documented result with a standard skin prick test either within 12 months prior to screening or performed at the screening visit. A positive test is defined as a wheal diameter at least 3 mm larger than the control wheal (normal saline) for the skin prick test. The subject's positive allergen test must be consistent with the medical history of SAR, 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 Allergic Rhinitis diary and Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ). Exclusion Criteria:

- 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 (SARS), 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.

- Plans to travel outside the study area (the known pollen area for the investigative

site) for 2 or more consecutive days between Randomization Visit and the final Treatment Visit.

- Plans to leave the study area (the known pollen area for the investigative site) for

longer than 24 hours during the Single-blind Placebo Run-in period.

- Is expecting to use any disallowed concomitant medications during the treatment

period.

- Is planning initiation of immunotherapy during the study period or dose escalation

during the study period. However, initiation of immunotherapy 90 days or more prior to the screening visit and use of a stable (maintenance) dose (30 days or more) may be considered for inclusion.

- Has nonvaccinated exposure to or active infection with chickenpox or measles within

the 21 days preceding the screening visit.

- Initiates pimecrolimus cream 1% or greater or tacrolimus ointment 0. 03% or greater

during the study period or plans a dose escalation during the study period. However, initiation of these creams/ointments 30 days or more prior to screening and use of a stable (maintenance) dose during the study period may be considered for inclusion.

- Is a child or relative of any clinical investigator or site personnel, even those who

are not directly involved 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; any systemic infection hematological (including anemia), hepatic, renal, endocrine disease; gastrointestinal disease; malignancy (excluding basal cell carcinoma); current neuropsychological condition with or without drug therapy. Any behavioral condition that could affect subject's ability to accurately report symptoms to the caregiver such as developmental delay, attention deficit disorder, and autism.

- Has any condition that, in the judgment of the investigator, would preclude the

subject from completing the protocol with capture of the assessments as written.

- Has received ciclesonide nasal aerosol in a previous clinical trial

Locations and Contacts

Arkansas Pediatric Clinic, Little Rock, Arkansas 72205, United States

San Jose Multispecialty Medical Group, Inc, Baldwin Park, California 91706, United States

WCCT Global, LLC, Costa Mesa, California 92626, United States

Premier Health Research Center, Downey, California 90241, United States

Allergy, Asthma, Brochitis and Immunology Assoc Medical Group, Fountain Valley, California 92708, United States

Pediatric Care Medical Group, Huntington Beach, California 92647, United States

Pediatric Care Medical Group, Inc., Huntington Beach, California 92647, United States

Allergy and Asthma Associates of Southern California, Mission Viejo, California 92691, United States

CHOC, PSF, AMC, Division of Allergy, Asthma, and Immunology, Orange, California 92868, United States

Center for Clinical Trials, LLC, Paramount, California 90723, United States

Peninsula Research Associates, Rolling Hills Estates, California 90274, United States

Capital Allergy & Respiratory Disease Center, Sacramento, California 95819, United States

Allergy & Asthma Medical Group and Research Center, APC, San Diego, California 92123, United States

Allergy Associates Medical Group, San Diego, California 92120, United States

Bensch Research Associates, Stockton, California 95207, United States

Asthma & Allergy Associates, PC, Colorado Springs, Colorado 80907, United States

Storms Clinical Research Institute, Colorado Springs, Colorado 80907, United States

Colorado Allergy and Asthma Centers, PC, Denver, Colorado 80230, United States

Northeast Georgia Research Center, Gainesville, Georgia 30501, United States

DataQuest Medical Research, LLC, Lawerenceville, Georgia 30046, United States

Atlanta Allergy & Astma Clinic, Marietta, Georgia 30188, United States

Aeroallergy Research Laboratories of Savannah, Inc, Savannah, Georgia 31406, United States

Clinical Research Atlanta, Stockbridge, Georgia 30281, United States

Alzein Pediatrics, Evergreen Park, Illinois 60805, United States

Sneeze, Weeze, & Itch Associates, Normal, Illinois 61761, United States

Gordon D. Raphael, MD, Berthesda, Maryland 20814, United States

Clinical Research Institute, Plymouth, Minnesota 55441, United States

Creighton University Medical Center, Omaha, Nebraska 68131, United States

Atlantic Research Center, LLC, Ocean, New Jersey 07712, United States

North Carolina Clinical Research, Raleigh, North Carolina 27607, United States

Catalyst Medical Center, Fargo, North Dakota 58103, United States

Toledo Center for Clinical Research, Sylvania, Ohio 43560, United States

Baker Allergy Asthma and Dermatology Research Center LLC, Lake Oswego, Oregon 97035, United States

Clinical Research Institute of Southern Oregon, PC, Medford, Oregon 97504, United States

Allergy Associates Research Center, Portland, Oregon 97202, United States

Asthma and Allergy Research Associates, Upland, Pennsylvania 19013, United States

Asthma, Nasal Disease & Allergy Research Center of New England, Providence, Rhode Island 02906, United States

National Allergy, Asthma, and Uticaria Centers of Charleston, PA, Charleston, South Carolina 29407, United States

Spartanburg Medical Research, Spartanburg, South Carolina 29303, United States

DCT - Anchor, LLC dba Discovery Clinical Trials, Arlington, Texas 76018, United States

Discovery Clinical Trials, Arlington, Texas 76018, United States

Benchmark Research, Austin, Texas 78705, United States

Isis Clinical Research, LLC, Austin, Texas 78731, United States

Sirius Clinical Research LLC, Austin, Texas 78759, United States

TTS Research Center, Boeme, Texas 78006, United States

Research Across America, Carroliton, Texas 75010, United States

Dallas Allergy Immunology Research, Dallas, Texas 75230, United States

Pharmaceutical Research and Consulting, Dallas, Texas 75231, United States

Western Sky Medical Research, El Paso, Texas 79903, United States

Benchmark Research, Fort Worth, Texas 76135, United States

Kerrville Research Associates, Kerrville, Texas 78028, United States

Live Oak Allergy and Asthma Clinic, Live Oak, Texas 78233, United States

Central Texas Health Research, New Braunfels, Texas 78130, United States

ACRC Trials, Plano, Texas 75024, United States

North Texas Family Medicine, Plano, Texas 75093, United States

Benchmark Research, San Angelo, Texas 76904, United States

Allergy and Asthma Research Center, PA, San Antonio, Texas 78229, United States

DCT - Barlite Dba Discovery Clinical Trials, San Antonio, Texas 78224, United States

DCT-Westover Hills, Dba Discovery Clinical Trials, San Antonio, Texas 78251, United States

San Antonio Ear, Nose & Throat Research, San Antonio, Texas 78229, United States

Sun Research Institute, San Antonio, Texas 78215, United States

Sylvana Research Associates, San Antonio, Texas 78229, United States

Pediatric Healthcare of Northwest Houston, Tomball, Texas 77375, United States

Allergy & Asthma Care of Waco, Waco, Texas 76712, United States

Allergy Asthma Research Institute, Waco, Texas 76712, United States

Ericksen Research and Development, Clinton, Utah 84015, United States

Additional Information

Starting date: November 2011
Last updated: April 16, 2014

Page last updated: August 23, 2015

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