Evaluation of a Novel Questionnaire to Assess Patient Satisfaction With and Preference of Intranasal Corticosteroids for the Treatment of Allergic Rhinitis
Condition: Perennial Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Intervention: ciclesonide hydrofluoroalkane (HFA) nasal aerosol; mometasone nasal inhalation
Intervention description: ciclesonide hydrofluoroalkane (HFA) nasal aerosol 80 μg once daily for one week.; mometasone nasal inhalation 200 μg once daily for one week
Intervention MeSH terms: Mometasone Furoate; Ciclesonide
Phase: Phase 3
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 185.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: perennial allergic rhinitis; PAR

Summary:

      This is an open-label, randomized, multicenter, 2-way crossover study in subjects 12 years or
      older with perennial allergic rhinitis (PAR) to evaluate the psychometric properties of a
      novel-patient administered assessment of treatment satisfaction with and preference of an
      Internasal Corticosteroid (INCS)
    

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.

          -  Male or female 12 years and older at 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 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 was
             a nasal spray.

          -  A demonstrated sensitivity to at least one 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 or 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 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: a. 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
             study participation. b.Barrier method of contraception, e.g., condom and/or diaphragm
             with spermicide while participating in the study. c.Abstinence.

          -  The subject must possess a degree of understanding of written English, in the opinion
             of the investigator that enables them to complete the Phase V® Technologies Inc. (PVT)
             Modules.

        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 screening.

          -  Presently has nasal jewelry, has had a nasal piercing, or a history of nasal surgery
             (e.g., rhinoplasty, septoplasty) or trauma to the nasal cavity.

          -  Subject is, in the investigator's judgment, having a seasonal exacerbation at
             screening.

          -  Participation in any investigational drug trial within the 30 days preceding screening
             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 Nasonex.

          -  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 screening.

          -  History of alcohol or drug abuse within 2 years preceding 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 (e.g., 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 preceding 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, e.g., 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.