Seasonal Allergic Rhinitis Clinical Trial
Official title:
Prospective Observational Study of Concomitant Allergic Rhinitis Treatment Patterns Among Patients Starting on Fluticasone Furoate Nasal Spray in a Retail Pharmacy Setting
This study is a prospective observational cohort study with 3-month follow-up among a cohort
of intranasal steroid (INS) -experienced patients newly starting fluticasone furorate nasal
spray (FFNS). The primary aim is to examine the effect of FFNS on the use and associated
cost of concomitant allergic rhinitis medications in INS-experienced patients starting
treatment with FFNS who have a history of prior concomitant medication use. The secondary
aim will be to determine the effect of FFNS on control of allergic rhinitis, as assessed by
the Rhinitis Control Assessment Test (RCAT).
Adult patients filling a new FFNS prescription will be recruited (within 4 days of starting
their FFNS) across 50 branches of a retail pharmacy chain with co-located convenient care
clinics. Approximately 350 patients who have active seasonal rhinitis and have used an INS
other than FFNS and another prescription or over-the-counter allergy medication in the
previous allergy season will be eligible for the study. A baseline questionnaire will be
administered to collect information on patient demographics, a brief medical history of the
patient's rhinitis, prior use of INS and other prescription and over-the-counter medications
taken for allergic rhinitis, total out of pocket costs for the prior allergy season, number
of office visits due to allergic rhinitis, and level of control of symptoms of allergic
rhinitis.
At 1, 2, and 3 months post-enrollment, a follow-up questionnaire will be administered to
collect information on medications taken for allergic rhinitis, office visits due to
rhinitis, and level of control of symptoms of allergic rhinitis. In addition, pharmacy
claims data will be abstracted for patients 1 year prior to enrollment and 4 months after
enrollment to verify and supplement patient reported data as needed.
The primary outcomes will be rate of use of non-INS concomitant medications (frequency and
duration) at baseline, and 1, 2, and 3 months follow-up and change in rate of use of non-INS
concomitant medications (post vs. pre and from baseline to 3 months follow-up). Secondary
outcomes will be change in total allergic rhinitis pharmacy expenditures (post vs. pre and
from baseline to follow-up) and change in the level of control of allergic rhinitis, as
measured by score on the Rhinitis Control Assessment Test (RCAT), from baseline to
follow-up.
n/a
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