Clinical trial NCT00953147: A 6 Month Safety and Efficacy Study of Once Daily Ciclesonide Hydrofluoroalkane (HFA) in the Treatment of Perennial Allergic Rhinitis (PAR) in Subjects 12 Years and Older
Official title: A 6-Month Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Efficacy and Safety Study of Once Daily Ciclesonide HFA Nasal Aerosol (80 and 160 μg) in The Treatment of Perennial Allergic Rhinitis (PAR) in Subjects 12 Years and Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergic Rhinitis
Perennial Allergic Rhinitis
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2009-08-06
Enrollment: 1110
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a 6-month multi-center, randomized, double-blind, placebo-controlled, parallel group, efficacy and safety study of ciclesonide HFA nasal aerosol administered once-daily to male and female subjects 12 years or older diagnosed with perennial allergic rhinitis (PAR).

Detailed description: This study will investigate the efficacy and safety of once daily ciclesonide HFA Nasal Aerosol for 26 weeks. The primary objective is to evaluate the efficacy of ciclesonide HFA (80 mcg and 160 mcg) over 6 weeks, compared to placebo in subjects with PAR. Secondary objectives are to evaluate safety and tolerability and quality of life after treatment with ciclesonide HFA (80 mcg and 160 mcg), over 6 weeks and over 6 months.

The study will consist of a Screening period (7 to 21 (±3) days) from Visit 1 to Visit 2, followed by a Single-blind Placebo Run-in period (7 to 10 days) from Visit 2 to Visit 3, followed by a 6-month (26 weeks) double-blind treatment period (Visit 3 through Visit 11). Subjects who complete this study will be allowed to participate in a 6-month open-label extension study (Study 060-635).

This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Eligibility criteria: Inclusion Criteria:

* Give written informed consent and assent, including privacy authorization as well as adherence to concomitant medication withholding periods, prior to participation.
* Subject must be in general good health based on screening physical examination, medical history, and clinical laboratory values.
* If any of the Screening visit Hematology, Chemistries, or Urinalysis are not within the clinical laboratory's reference range, then the subject can be included only if the Investigator judges the deviations to be not clinically significant.
* A history of PAR to a relevant perennial allergen (house dust mites, cockroach, molds, animal dander) for a minimum of two years 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.
* A demonstrated sensitivity at the Screening visit to at least one allergen known to induce PAR (house dust mite, animal dander, cockroach, and molds) using a standard skin-prick test. The subject's positive allergen test must be consistent with the medical history of PAR and must be present in the subject's environment throughout the study.
* Based upon subject's medical history, in the Investigator's judgment, the subject is unlikely to have a seasonal exacerbation during the first 6 weeks of double-blind treatment.
* Subject, if female ≤65 years of age, must have a negative serum pregnancy test at screening. Females of childbearing potential must be instructed to and agree to avoid pregnancy during the study and must use an acceptable method of birth control.

Exclusion Criteria:

* Female subject who is pregnant or lactating.
* 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 last 60 days prior to the Screening visit.
* Subject is, in the investigator's judgement, having a seasonal exacerbation at the time of screening.
* Participation in any investigational drug trial within the 30 days preceding the Screening visit or planned participation in another investigational drug trial at any time during this trial.
* A known hypersensitivity to any corticosteroid or any of the excipients in the formulation of ciclesonide.
* History of a respiratory infection or disorder \[including, but not limited to bronchitis, pneumonia, influenza, severe acute respiratory syndrome (SARS)\] within the 14 days preceding the Screening visit.
* History of alcohol or drug abuse within 2 years preceding the Screening visit .
* History of a positive test for HIV, hepatitis B or hepatitis C.
* Active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of beta agonists and any controller drugs (eg, theophylline, leukotriene antagonists, etc.); intermittent use (less than or equal to 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.
* Expected use of any disallowed concomitant medications during the treatment period.
* 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.
* Previous participation in an intranasal ciclesonide HFA nasal aerosol study.
* Non-vaccinated exposure to or active infection with, chickenpox or measles within the 21 days preceding the Screening Visit.
* Initiation of pimecrolimus cream 1% or greater or tacrolimus ointment 0.03% or greater during the study period or planned dose escalation during the study period.
* Study participation by clinical investigator site employees and/or their immediate relatives who reside in the same household.
* Study participation by more than one subject from the same household.
* Have any of the following conditions that are judged by the investigator to be clinically significant and/or affect the subject's ability to participate in the clinical trial:

  * impaired hepatic function including alcohol related liver disease or cirrhosis
  * history of ocular disturbances, eg, glaucoma or posterior subcapsular cataracts
  * any systemic infection
  * hematological, hepatic, renal, endocrine (except for controlled diabetes mellitus or postmenopausal symptoms or hypothyroidism)
  * gastrointestinal disease
  * malignancy (excluding basal cell carcinoma)
  * current neuropsychological condition with or without drug therapy • Any condition that, in the judgment of the investigator, would preclude the subject from completing the protocol with capture of the assessments as written.

Primary outcomes:
measure: Change From Baseline in Daily Subject-reported AM and PM Reflective TNSS (rTNSS) Averaged Over the First 6 Weeks of Double-blind Treatment
timeFrame: Weeks 0-6
Secondary outcomes:
measure: Change From Baseline in Daily Subject-reported AM and PM Instantaneous TNSS (iTNSS) Averaged Over the First 6 Weeks of Double-blind Treatment
timeFrame: Weeks 0-6
measure: Change From Baseline in Daily Subject-reported AM rTNSS Averaged Over the First 6 Weeks of Double-blind Treatment.
timeFrame: Weeks 0-6
measure: Change From Baseline in Daily Subject-reported PM rTNSS Averaged Over the First 6 Weeks of Double-blind Treatment.
timeFrame: Weeks 0-6
measure: Change From Baseline in Daily Subject-reported AM iTNSS Averaged Over the First 6 Weeks of Double-blind Treatment.
timeFrame: Weeks 0-6
measure: Change From Baseline in Daily Subject-reported PM iTNSS Averaged Over the First 6 Weeks of Double-blind Treatment.
timeFrame: Weeks 0-6
measure: Change From Baseline in Daily Subject-reported AM rNSS Averaged Over the First 6 Weeks of the Double-blind Treatment
timeFrame: Weeks 0 - 6
measure: Change From Baseline in Daily Subject-reported PM rNSS Averaged Over the First 6 Weeks of the Double-blind Treatment
timeFrame: Weeks 0-6
measure: Change From Baseline in Daily Subject-reported AM & PM rNSS Averaged Over the First 6 Weeks of Double-blind Treatment Period.
timeFrame: Weeks 0-6
measure: Change From Baseline in Daily Subject-reported AM iNSS Averaged the First 6 Weeks of the Double-blind Treatment
timeFrame: Weeks 0-6
measure: Change From Baseline in Daily Subject-reported PM iNSS Averaged the First 6 Weeks of the Double-blind Treatment
timeFrame: Weeks 0-6
measure: Change From Baseline in Daily Subject-reported AM and PM iNSS Averaged Over the First 6 Weeks of Double-blind Treatment Period
timeFrame: Weeks 0-6
measure: Change From Baseline to Week 6 in Rhinoconjunctivitis Quality of Life Questionnaire With Standardized [RQLQ(S)] Overall Score in Impaired Patients With Baseline RQLQ(S) Score ≥3.0
timeFrame: Baseline and Week 6
measure: Change From Baseline to Month 6 (Week 26) in RQLQ(S) Overall Score in Impaired Patients With Baseline RQLQ(S) Score ≥3.0.
timeFrame: Baseline and Week 26
Other outcomes:
Locations:
city: Huntington Beach
country: United States
facility: Asthma and Allergy Specialists Medical Group
state: California
city: Los Angeles
country: United States
facility: California Allergy and Asthma Medical Group
state: California
city: Mission Viejo
country: United States
facility: Southern California Research
state: California
city: Orange
country: United States
facility: CHOC PSF, AMC, Division of Allergy Asthma & Immunology
state: California
city: Palmdale
country: United States
facility: California Allerga and Asthma Medical Group
state: California
city: San Diego
country: United States
facility: Allergy Associates Medical Group
state: California
city: San Diego
country: United States
facility: Allergy and Asthma Medical Group and Research Center
state: California
city: Stockton
country: United States
facility: Bensch Research Associates
state: California
city: Colorado Springs
country: United States
facility: Asthma and Allergy Associates, P.C.
state: Colorado
city: Colorado Springs
country: United States
facility: Storms Clinical Research Institute
state: Colorado
city: Denver
country: United States
facility: Colorado Allergy and Asthma Centers
state: Colorado
city: Atlanta
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Lawrenceville
country: United States
facility: DataQuest Medical Research, LLC
state: Georgia
city: Lilburn
country: United States
facility: Allergy and Asthma Consultants, PC
state: Georgia
city: Stockbridge
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Indianapolis
country: United States
facility: Clinical Research Center of Indiana
state: Indiana
city: Bethesda
country: United States
facility: Gordon D. Raphael, MD
state: Maryland
city: North Dartmouth
country: United States
facility: Northeast Medical Research Associates, Inc.
state: Massachusetts
city: St. Louis
country: United States
facility: The Clinical Research Center, LLC
state: Missouri
city: Bozeman
country: United States
facility: Clinical Research Group of Montana
state: Montana
city: Skillman
country: United States
facility: Princeton Center for Clinical Research
state: New Jersey
city: High Point
country: United States
facility: Allergy and Asthma Center of NC
state: North Carolina
city: Raleigh
country: United States
facility: North Carolina Clinical Research
state: North Carolina
city: Sylvania
country: United States
facility: Toledo Center for Clinical Research
state: Ohio
city: Eugene
country: United States
facility: Allergy and Asthma Research Group
state: Oregon
city: Lake Oswego
country: United States
facility: Baker Allergy, Asthma and Dermatology Research Center, LLC
state: Oregon
city: Portland
country: United States
facility: Allergy Associates Research Center
state: Oregon
city: Bethlehem
country: United States
facility: Valley Clinical Research Center
state: Pennsylvania
city: Upland
country: United States
facility: Asthma and Allergy Research Associates
state: Pennsylvania
city: Providence
country: United States
facility: Asthma, Nasal Disease and Allergy Research Center of New England
state: Rhode Island
city: Charleston
country: United States
facility: National Allergy, Asthma, and Urticaria
state: South Carolina
city: Austin
country: United States
facility: Allergy and Asthma Associates
state: Texas
city: Austin
country: United States
facility: Sirius Clinical Research
state: Texas
city: Boerne
country: United States
facility: Hill Country Family Medical Center
state: Texas
city: Dallas
country: United States
facility: Pharmaceutical Research and Consulting
state: Texas
city: El Paso
country: United States
facility: Western Sky Medical Research
state: Texas
city: Fort Worth
country: United States
facility: North Texas Institute for Clinical Trials
state: Texas
city: Houston
country: United States
facility: Allergy and Asthma Associates
state: Texas
city: Kerrville
country: United States
facility: Kerrville Research Associates, PA
state: Texas
city: Kerrville
country: United States
facility: Kerrville Research Associates
state: Texas
city: New Braunfels
country: United States
facility: Central Texas Health Research
state: Texas
city: San Antonio
country: United States
facility: Biogenics Research Institute
state: Texas
city: San Antonio
country: United States
facility: Southwest Allergy and Asthma Center
state: Texas
city: San Antonio
country: United States
facility: Sylvana Research Associates
state: Texas
city: Seattle
country: United States
facility: ASTHMA, Inc.
state: Washington
Study officials:
References:
citation: Mohar D, Berger WE, Laforce C, Raphael G, Desai SY, Huang H, Hinkle J. Efficacy and tolerability study of ciclesonide nasal aerosol in patients with perennial allergic rhinitis. Allergy Asthma Proc. 2012 Jan-Feb;33(1):19-26. doi: 10.2500/aap.2012.33.3522.