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.
Change from baseline in subject-reported AM and PM instantaneous TNSS averaged over the two-week treatment period.Change from baseline in subject-reported AM and PM reflective TOSS averaged over the two-week treatment period in subjects.
Change from baseline in subject-reported AM reflective TNSS, PM reflective TNSS, AM and PM reflective TNSS at each day, averaged over each week, and averaged over the two-week treatment period.
Change from baseline in subject-reported AM instantaneous TNSS, PM instantaneous TNSS, AM and PM instantaneous TNSS at each day, averaged over each week, and averaged over the two-week treatment period.
Change from baseline in subject-reported AM reflective TOSS, PM reflective TOSS, AM and PM reflective TOSS at each day, averaged over each week, and averaged over the two-week treatment period in subjects.
Change from baseline in subject-reported AM instantaneous TOSS, PM instantaneous TOSS, AM and PM instantaneous TOSS at each day, averaged over each week, and averaged over the two-week treatment period in subjects.
Change from baseline in subject-reported individual AM reflective NSS, individual PM reflective NSS, individual AM and PM reflective NSS at each day, averaged over each week, and averaged over the two-week treatment period.
Change from baseline in subject-reported individual AM reflective OSS, individual PM reflective OSS, individual AM and PM reflective OSS at each day, averaged over each week, and averaged over the two-week treatment period in subjects.
Change from baseline in subject-reported individual AM instantaneous OSS, individual PM instantaneous OSS, individual AM and PM instantaneous OSS at each day, averaged over each week, and averaged over the two-week treatment period in subjects.
Change from baseline in Rhinoconjunctivitis Quality of Life Questionnaire with Standardised Activities (RQLQ(S)) total and individual items at each day, averaged over each week, and averaged over the two-week treatment period in impaired patients.
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 judgement of the investigator, would preclude the subject
from completing the protocol with capture of the assessments as written.
