Study To Evaluate Patient Preference, Satisfaction And Efficacy Of a Nasal Aerosol Versus an Aqueous Nasal Spray
Condition: Perennial Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Intervention: ciclesonide; mometasone
Intervention description: 74 mcg ciclesonide nasal aerosol once daily; 200 mcg mometasone aqueous nasal spray once daily
Intervention MeSH terms: Mometasone Furoate; Ciclesonide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 327.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: perennial allergic rhinitis; PAR

Summary:

      This is a randomized, multicenter, 2-way crossover study in subjects 12 years or older with
      perennial allergic rhinitis (PAR) to evaluate patient preference, satisfaction and efficacy
      of ciclesonide nasal aerosol versus mometasone aqueous nasal spray. A novel
      patient-administered assessment, developed and validated to measure patient satisfaction with
      and preference of intranasal corticosteroids (INCS) for the treatment of allergic rhinitis
      (AR), is utilized in this study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Give written informed consent and/or assent (as appropriate), including privacy
             authorization as well as adherence to concomitant medication withholding periods,
             prior to participation.

          -  Male or female 12 years and older prior to screening

          -  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, clinical laboratory results, and medical history.

          -  A documented history of PAR to a relevant perennial allergen (house dust mites,
             cockroach, molds, animal dander) for a minimum of two years immediately preceding
             screening. The PAR must have been of sufficient severity to have required treatment
             (either continuous or intermittent) in the past, and require treatment with an INCS
             throughout the entire study period.

          -  At least one treatment for PAR during the 6 months prior to expected randomization, 14
             days, with a nasal spray.

          -  A demonstrated sensitivity to at least 1 allergen known to induce PAR (house dust
             mites, animal dander, cockroach, and molds) based on a documented result with a
             standard skin-prick test either within 90 days prior to screening or performed at
             screening. A positive test is defined as a wheal diameter at least 3 mm larger than
             the negative control wheal for the skin-prick test. The subject's positive test for
             the allergen must be consistent with the medical history of PAR and the allergen 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 allergy exacerbation during the study.

          -  Subject, if female ≤ 65 years of age, must have a negative serum pregnancy test prior
             to 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:
             An oral contraceptive, an intrauterine device (IUD), implantable contraceptive,
             transdermal or injectable contraceptive for at least 1 month prior to entering the
             study with continued use throughout the study and for 30 days following completion of
             the study; Barrier method of contraception, eg, condom and/or diaphragm with
             spermicide while participating in the study; Abstinence.

          -  The subject must possess a degree of understanding of written English, in the opinion
             of the investigator, that enables them to complete study participation

        Exclusion Criteria:

          -  Female subject who is pregnant or lactating.

          -  History of physical findings of clinically significant nasal pathology, including
             nasal polyps or other respiratory tract malformations; recent nasal biopsy; nasal
             trauma; or nasal ulcers or perforations. Clinically insignificant findings may be
             allowed if, in the investigator's judgment, the findings are unlikely to impact on:
             the safety or efficacy of an INCS: the subject's perception of treatment with an INCS.

          -  Surgery and atrophic rhinitis or rhinitis medicamentosa within the last 60 days prior
             to screening

          -  Presently has nasal jewelry, has had a nasal piercing, or a history of nasal surgery
             (eg, rhinoplasty, septoplasty) or trauma to the nasal cavity.

          -  Subject is, in the investigator's judgment, having a seasonal exacerbation prior to
             screening

          -  Participation in any investigational drug trial within the 30 days prior to screening,
             participation in a previous study involving the ARTSP instrument, or planned
             participation in another investigational drug trial at any time during this study.

          -  A known hypersensitivity to any corticosteroid or any of the components in the
             formulations of ciclesonide or mometasone.

          -  History of a respiratory infection or disorder (including, but not limited to,
             bronchitis, pneumonia, influenza, severe acute respiratory syndrome [SARS]) within the
             14 days prior to screening

          -  History of alcohol or drug abuse within 2 years prior to screening

          -  History of a positive test for human immunodeficiency virus (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 three uses per week) of
             inhaled short-acting beta-agonists is acceptable. Use of short-acting beta-agonists
             for exercise-induced bronchospasm is allowed.

          -  Expected use of any disallowed medications during the study period.

          -  Expected initiation of immunotherapy during the study period or planned dose
             escalation during the study period. However, initiation of immunotherapy 90 days or
             more prior to screening and use of a stable (maintenance) dose (30 days or more) may
             be considered for inclusion.

          -  Non-vaccinated exposure to or active infection with chickenpox or measles within the
             21 days prior to screening

          -  Expected 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 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) disease,
             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 completion of the assessments as written.

          -  Any use of mometasone nasal spray within 3 months prior to screening

          -  Any prior use of ciclesonide nasal aerosol.