Clinical Trial to Assess the Efficacy and Safety of Ciclesonide Hydrofluoroalkane (HFA) Nasal Aerosol for the Treatment of Seasonal Allergic Rhinitis (SAR) to Mountain Cedar in Subjects 12 Years and Older
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: Ciclesonide HFA 160 μg; Ciclesonide HFA 80 μg; Placebo
Intervention description: Ciclesonide HFA Nasal Aerosol 160 μg once daily; Ciclesonide HFA Nasal Aerosol 80 μg once daily; Placebo HFA Nasal Aerosol once daily
Intervention MeSH terms: Ciclesonide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 671.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Mountain Cedar

Summary:

      This clinical research study will evaluate the safety and effectiveness of two doses of an
      investigational medication (ciclesonide nasal aerosol) for the treatment of subjects with of
      seasonal allergic rhinitis (SAR). The study will consist of a Screening Period to confirm
      study eligibility, followed by a Single-Blind Placebo Run-in period to acclimate subjects to
      the proper use of the study medication and to assess the subject's severity of SAR symptoms,
      followed by a 2-week double-blind treatment period to assess the safety and effectiveness of
      the study medication when given to eligible subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Give written informed consent, including privacy authorization as well as adherence to
             concomitant medication withholding periods, prior to participation.

          -  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). If any of the 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 SAR to Mountain Cedar for a minimum of 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 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 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. 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: 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; Barrier method of contraception, eg, condom and/or diaphragm with
             spermicide while participating in the study; 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 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 .

          -  History of alcohol or drug abuse 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 and the final
             Treatment Visit.

          -  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 any disallowed 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.

          -  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 screening 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 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 judgement of the investigator, would preclude the subject
             from completing the protocol with capture of the assessments as written.