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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01458275
Other study ID # SEP060-305
Secondary ID
Status Completed
Phase Phase 3
First received October 20, 2011
Last updated April 16, 2014
Start date November 2011
Est. completion date March 2013

Study information

Verified date April 2014
Source Sunovion
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 847
Est. completion date March 2013
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender Both
Age group 6 Years to 11 Years
Eligibility 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

Study Design

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


Intervention

Drug:
Ciclesonide nasal aerosol 37 mcg
ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
ciclesonide nasal aerosol 74 mcg
ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
Placebo
Placebo - one actuation per nostril

Locations

Country Name City State
United States DCT - Anchor, LLC dba Discovery Clinical Trials Arlington Texas
United States Discovery Clinical Trials Arlington Texas
United States Benchmark Research Austin Texas
United States Isis Clinical Research, LLC Austin Texas
United States Sirius Clinical Research LLC Austin Texas
United States San Jose Multispecialty Medical Group, Inc Baldwin Park California
United States Gordon D. Raphael, MD Berthesda Maryland
United States TTS Research Center Boeme Texas
United States Research Across America Carroliton Texas
United States National Allergy, Asthma, and Uticaria Centers of Charleston, PA Charleston South Carolina
United States Ericksen Research and Development Clinton Utah
United States Asthma & Allergy Associates, PC Colorado Springs Colorado
United States Storms Clinical Research Institute Colorado Springs Colorado
United States WCCT Global, LLC Costa Mesa California
United States Dallas Allergy Immunology Research Dallas Texas
United States Pharmaceutical Research and Consulting Dallas Texas
United States Colorado Allergy and Asthma Centers, PC Denver Colorado
United States Premier Health Research Center Downey California
United States Western Sky Medical Research El Paso Texas
United States Alzein Pediatrics Evergreen Park Illinois
United States Catalyst Medical Center Fargo North Dakota
United States Benchmark Research Fort Worth Texas
United States Allergy, Asthma, Brochitis and Immunology Assoc Medical Group Fountain Valley California
United States Northeast Georgia Research Center Gainesville Georgia
United States Pediatric Care Medical Group Huntington Beach California
United States Pediatric Care Medical Group, Inc. Huntington Beach California
United States Kerrville Research Associates Kerrville Texas
United States Baker Allergy Asthma and Dermatology Research Center LLC Lake Oswego Oregon
United States DataQuest Medical Research, LLC Lawerenceville Georgia
United States Arkansas Pediatric Clinic Little Rock Arkansas
United States Live Oak Allergy and Asthma Clinic Live Oak Texas
United States Atlanta Allergy & Astma Clinic Marietta Georgia
United States Clinical Research Institute of Southern Oregon, PC Medford Oregon
United States Allergy and Asthma Associates of Southern California Mission Viejo California
United States Central Texas Health Research New Braunfels Texas
United States Sneeze, Weeze, & Itch Associates Normal Illinois
United States Atlantic Research Center, LLC Ocean New Jersey
United States Creighton University Medical Center Omaha Nebraska
United States CHOC, PSF, AMC, Division of Allergy, Asthma, and Immunology Orange California
United States Center for Clinical Trials, LLC Paramount California
United States ACRC Trials Plano Texas
United States North Texas Family Medicine Plano Texas
United States Clinical Research Institute Plymouth Minnesota
United States Allergy Associates Research Center Portland Oregon
United States Asthma, Nasal Disease & Allergy Research Center of New England Providence Rhode Island
United States North Carolina Clinical Research Raleigh North Carolina
United States Peninsula Research Associates Rolling Hills Estates California
United States Capital Allergy & Respiratory Disease Center Sacramento California
United States Benchmark Research San Angelo Texas
United States Allergy and Asthma Research Center, PA San Antonio Texas
United States DCT - Barlite Dba Discovery Clinical Trials San Antonio Texas
United States DCT-Westover Hills, Dba Discovery Clinical Trials San Antonio Texas
United States San Antonio Ear, Nose & Throat Research San Antonio Texas
United States Sun Research Institute San Antonio Texas
United States Sylvana Research Associates San Antonio Texas
United States Allergy & Asthma Medical Group and Research Center, APC San Diego California
United States Allergy Associates Medical Group San Diego California
United States Aeroallergy Research Laboratories of Savannah, Inc Savannah Georgia
United States Spartanburg Medical Research Spartanburg South Carolina
United States Clinical Research Atlanta Stockbridge Georgia
United States Bensch Research Associates Stockton California
United States Toledo Center for Clinical Research Sylvania Ohio
United States Pediatric Healthcare of Northwest Houston Tomball Texas
United States Asthma and Allergy Research Associates Upland Pennsylvania
United States Allergy & Asthma Care of Waco Waco Texas
United States Allergy Asthma Research Institute Waco Texas

Sponsors (1)

Lead Sponsor Collaborator
Sunovion

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. Weeks 0 - 2 No
Secondary 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 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, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. Weeks 0 - 2 No
Secondary 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. TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TOSS symptom scores assess symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Weeks 0 - 2 No
Secondary Change From Baseline in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Overall Score at the End of the Double-blind Treatment Period. PRQLQ was developed to measure the functional problems (physical, emotional, and social) that are most troublesome to children with rhinoconjunctivitis. The PRQLQ has 23 questions in 5 domains (nose symptoms, eye symptoms, practical problems, activity limitation, and other symptoms). Children recalled how they were during the previous week and responded to each question on a 7-point scale (0 = not bothered to 6 = extremely bothered or 0 = none of the time to 6 = all of the time) for a total possible score of 138. The overall PRQLQ score is the mean of all 23 responses and the individual domain scores are the means of the items in those domains. Weeks 0 - 2 No
Secondary Change From Baseline in Average Daily Subject Reported AM Instantaneous Total Nasal Symptom Scores (iTNSS) Over the 2-week Double-blind Treatment Period TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions assessed in the AM. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe in the AM. Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. Weeks 0 - 2 No
Secondary 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. TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement
Weeks 0 - 2 No
Secondary Time to Maximal Effect in the AM and PM Reflective Total Nasal Symptom Scores (rTNSS) Over the 2-week Double-blind Treatment Period The time to maximal effect, defined as the number of days until the first treatment day on which the estimated difference between ciclesonide nasal aerosol and placebo was at least 90% of the largest estimated difference, was based on the analyses of change from baseline in the average of AM and PM rTNSS scores for each day. The time to achieve at least 90% of these estimated differences is presented. Weeks 0 - 2 No
Secondary Number of Subjects Experiencing Treatment-emergent AEs Treatment-Emergent Adverse Events Occurring in = 2% of Subjects in Any Treatment Group (ITT Population) Weeks 0 - 3 No
Secondary Percentage of Subjects Experiencing Treatment-emergent AEs Treatment-Emergent Adverse Events Occurring in = 2% of Subjects in Any Treatment Group (ITT Population) Weeks 0 - 3 No
Secondary Treatment-emergent AEs Causing Study Medication Discontinuation Weeks 0 - 3 No
Secondary Number of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation Weeks 0 - 3 No
Secondary Percentage of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation Weeks 0 - 3 No
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