Evaluation of a Novel Questionnaire to Assess Patient Satisfaction With and Preference of Intranasal Corticosteroids for the Treatment of Allergic Rhinitis

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
INCS. Subjects will be randomized to 1 of 2 treatment sequences:

Sequence 1: Treatment Period 1 = ciclesonide hydrofluoroalkane (HFA) nasal aerosol 80 μg
once daily; Treatment Period 2 = mometasone nasal inhalation 200 μg once daily

Sequence 2: Treatment Period 1 = mometasone nasal inhalation 200 μg once daily; Treatment
Period 2 = ciclesonide HFA nasal aerosol 80 μg once daily

Total study participation will be approximately 8 weeks including a 3-week
screening/baseline phase, a 1-week treatment period, a 1- to 2- week washout phase between
treatments, a second 1-week treatment period consisting of the alternate treatment, and an
additional 1-week follow up period after the last dose of study drug to assess safety.
Subjects are required to continue to meet eligibility criteria for the second treatment
period.

Nasal symptoms will be evaluated daily from 7 days prior to the first dose of study drug in
Treatment Period 1 through the last dose of study drug in Treatment Period 2. The Allergic
Rhinitis Satisfaction and Preference (ARTSP) and other Modules from the Phase V® e-Health
Outcomes Information System (Phase V Technologies, Wellesley MA) will be completed two times
during each treatment period (before the first dose and on the day after the last dose) via
the internet at the clinical site. Patient preference will be evaluated at the day after
last dose only.