Clinical trial NCT00790023: Clinical Trial to Assess the Efficacy and Safety of Ciclesonide Hydrofluoroalkane (HFA) Nasal Aerosol for the Treatment of Seasonal Allergic Rhinitis
Official title: A Randomized, Multicenter, Double Blind, Placebo Controlled, Parallel Group, Phase III Clinical Trial to Assess the Efficacy and Safety of Ciclesonide HFA Nasal Aerosol (160 μg Once Daily and 80 μg Once Daily) for the Treatment of Seasonal Allergic Rhinitis (SAR) to Mountain Cedar in Subjects 12 Years and Older.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Seasonal Allergic Rhinitis
Keywords: SAR
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2008-11-13
Enrollment: 707
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: To demonstrate the efficacy of ciclesonide HFA applied as a nasal aerosol (160 μg and 80 μg) once daily compared to placebo in subjects with SAR.

Detailed description: This is a randomized, double blind, placebo controlled, parallel group, multicenter study to demonstrate the efficacy of ciclesonide HFA applied as a nasal aerosol (160 μg and 80 μg) once daily compared to placebo in subjects with SAR. 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, including privacy authorization as well as adherence to concomitant medication withholding periods, prior to participation.
* Male or female 12 years and older, as of the Screening Visit (Visit 1).
* Subject must be in general good health (defined as the absence of any clinically relevant abnormalities as determined by the Investigator) based on screening physical examination, medical history, and clinical laboratory values (Hematology, Chemistries and Urinalysis).
* A history of SAR to Mountain Cedar for a minimum of two years immediately preceding the study Screening Visit (Visit 1). The SAR must have been of sufficient severity to have required treatment (either continuous or intermittent) in the past and in the Investigator's judgment (through exposure to allergen) is expected to require treatment throughout the entire study period.
* A demonstrated sensitivity to Mountain Cedar known to induce SAR through a standard skin prick test administered at Visit 1 (screening). A positive test is defined as a wheal diameter at least 5 mm larger than the control wheal (normal saline) for the skin prick test.
* Subject, if female 65 years of age or younger, must have a negative serum pregnancy test (performed at Visit 1) prior to randomization at Visit 2. Women of childbearing potential (excluding females at least two years postmenopausal or surgically sterile) must sign the Women of Childbearing Potential Addendum to the informed consent form. 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:

  1. An oral contraceptive, an intrauterine device (IUD), implantable contraceptive, transdermal or injectable contraceptive for at least 1 month prior to entering the study and will continue its use throughout the study and for thirty days following study participation.
  2. Barrier method of contraception, eg, condom and/or diaphragm with spermicide while participating in the study.
  3. Abstinence.
* 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 RQLQ(S).

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; nasal ulcers or perforations; or surgery and atrophic rhinitis or rhinitis medicamentosa (all within the last 60 days prior to the Screening Visit).
* Participation in any investigational drug trial within the 30 days preceding the Screening Visit (Visit 1) 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 \[including, but not limited to bronchitis, pneumonia, chronic sinusitis, influenza, severe acute respiratory syndrome (SARS)\] within the 14 days preceding the Screening Visit (Visit 1).
* History of alcohol or drug abuse (or a positive urine drug screen at Visit 1) within two years preceding the Screening Visit.
* History of a positive test for HIV, hepatitis B or hepatitis C.
* Plans to travel outside the study area (the known pollen area for the investigative site) for more than 24 hours during the Run in period.
* Plans to travel outside the study area (the known pollen area for the investigative site) for 2 or more consecutive days between Randomization Visit (Visit 3) and the final Treatment Visit (Visit 5).
* Active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of beta agonists and any controller drugs (e.g., 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 any prohibited concomitant medications within the prescribed (per protocol) time period prior to the Screening Visit and expected use during treatment period.
* Use of antibiotic therapy for acute conditions within 14 days prior to the Screening Visit. Low doses of antibiotics taken for prophylaxis are permitted if the therapy was started prior to the Screening Visit and is expected to continue throughout the trial.
* 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.
* Use of topical corticosteroids in concentrations in excess of 1% hydrocortisone or equivalent within 30 days prior to Visit 2; use of a topical hydrocortisone or equivalent in any concentration covering greater than 20% of the body surface; or presence of an underlying condition (as judged by the investigator) that can reasonably be expected to require treatment with such preparations during the course of the study.
* 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. However, initiation of these creams/ointments 30 days or more prior to the Visit 1 and use of a stable (maintenance) dose during the study period may be considered for inclusion.
* Study participation by clinical investigator site employees and/or their immediate relatives.
* Study participation by more than one subject from the same household at the same time.
* 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 e.g. 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 Total Nasal Symptom Score (rTNSS) Averaged Over the Two-week Treatment Period.
timeFrame: Week 0-2
Secondary outcomes:
measure: Change From Baseline in Daily Subject-reported AM and PM iTNSS Averaged Over the Two-week Treatment Period.
timeFrame: Week 0-2
measure: Change From Baseline in Daily Subject-reported AM and PM rTOSS Averaged Over the Two-week Treatment Period in Participants With a Baseline rTOSS >= 5.0
timeFrame: Week 0-2
measure: Change From Baseline in Daily Subject-reported AM rTNSS Averaged Over the Two Week Treatment Period
timeFrame: Week 0-2
measure: Change From Baseline in Daily Subject-reported PM rTNSS Averaged Over the Two Week Treatment Period
timeFrame: Week 0-2
measure: Change From Baseline in Daily Subject-reported AM iTNSS Averaged Over the Two Week Treatment Period
timeFrame: Week 0-2
measure: Change From Baseline in Daily Subject-reported PM iTNSS Averaged Over the Two Week Treatment Period
timeFrame: Week 0-2
measure: Change From Baseline in Daily Subject-reported AM rTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0
timeFrame: Week 0-2
measure: Change From Baseline in Daily Subject-reported PM rTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0
timeFrame: Week 0-2
measure: Change From Baseline in Daily Subject-reported AM iTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0
timeFrame: Week 0-2
measure: Change From Baseline in Daily Subject-reported PM iTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0
timeFrame: Week 0-2
measure: Change From Baseline in Daily Subject Reported AM and PM iTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0
timeFrame: Week 0-2
measure: Change From Baseline in Daily Subject-reported AM rNSS Averaged Over the Two Week Treatment Period
timeFrame: Week 0-2
measure: Change From Baseline in Daily Subject-reported PM rNSS Averaged Over the Two Week Treatment Period
timeFrame: Week 0-2
measure: Change From Baseline in Daily Subject-reported AM and PM rNSS Averaged Over the Two Week Treatment Period
timeFrame: Week 0-2
measure: Change From Baseline in Daily Subject-reported AM iNSS Averaged Over the Two Week Treatment Period
timeFrame: Week 0-2
measure: Change From Baseline in Daily Subject-reported PM iNSS Averaged Over the Two Week Treatment Period
timeFrame: Week 0-2
measure: Change From Baseline in Daily Subject-reported AM and PM iNSS Averaged Over the Two Week Treatment Period
timeFrame: Week 0-2
measure: Change From Baseline in Daily Subject-reported AM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0
timeFrame: Week 0-2
measure: Change From Baseline in Daily Subject-reported PM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0
timeFrame: Week 0-2
measure: Change From Baseline in Daily Subject-reported and AM and PM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0
timeFrame: Week 0-2
measure: Change From Baseline in Daily Subject-reported AM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0
timeFrame: Week 0-2
measure: Change From Baseline in Daily Subject-reported PM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0
timeFrame: Week 0-2
measure: Change From Baseline in Daily Subject-reported AM and PM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0
timeFrame: Week 0-2
measure: Change From Baseline in Overall Score of the Rhinoconjunctivitis Quality of Life Questionnaire With Standard Activities (RQLQ(S)) in Participants With a Baseline Overall Score >= 3.0
timeFrame: Week 0-2
measure: Onset of Improvement in Instantaneous Total Nasal Symptoms Scores (iTNSS)
timeFrame: Baseline and up to 36 hours
measure: Onset of Improvement in Instantaneous Total Ocular Symptoms Scores (iTOSS) in Subjects With Baseline iTOSS ≥5.0
timeFrame: Baseline and up to 48 hours
measure: Time to Maximal Effect as Measured by Change From Baseline in the Average AM and PM Reflective Total Nasal Symptoms Scores (rTNSS)
timeFrame: Week 0-2
Other outcomes:
Locations:
city: Austin
country: United States
state: Texas
city: Kerrville
country: United States
state: Texas
city: New Braunfels
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
Study officials:
References:
citation: Ratner P, Jacobs R, Mohar D, Huang H, Desai SY, Hinkle J. Evaluation of the efficacy and safety of ciclesonide hydrofluoroalkane nasal aerosol, 80 or 160 mug once daily, for the treatment of seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2010 Dec;105(6):471-9. doi: 10.1016/j.anai.2010.09.024.