Clinical trial NCT01337323: Prospective Observational Study of Concomitant Allergic Rhinitis Treatment Patterns Among Patients Starting on Fluticasone Furoate Nasal Spray in a Retail Pharmacy Setting
Official title: Prospective Observational Study of Concomitant Allergic Rhinitis Treatment Patterns Among Patients Starting on Fluticasone Furoate Nasal Spray in a Retail Pharmacy Setting
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Rhinitis, Allergic, Seasonal
Seasonal Allergic Rhinitis
Keywords: allergic rhinitis, allergies, concomitant medications, allergy symptoms
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-04-18
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients filling a new fluticasone furorate nasal spray (FFNS) prescription will be recruited across 50 branches of a retail pharmacy chain with co-located convenient care clinic located throughout the United States. Approximately 350 patients who have active seasonal rhinitis and have used an intra-nasal steroid (INS) other than FFNS and another prescription or over-the-counter allergy medication in the previous allergy season will be enrolled in the study.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Active seasonal allergic rhinitis
* Initiating first-time treatment with fluticasone furoate nasal spray (FFNS)
* Received treatment with at least one intra-nasal steroid (INS) other than FFNS during the last allergy season
* Received treatment with one or more antihistamines, leukotriene receptor atagonists (LTRA), topical ocular medications, or any over the counter (OTC) medication for allergic rhinitis symptoms during the last allergy season
* At least 18 years of age at the time of study enrollment
* Able to read, comprehend, and record information in English
* Have provided an appropriately signed and dated informed consent

Exclusion Criteria:

* Received prior treatment with FFNS
* Pregnant
* Employee or family members of an employee of the study sponsor, retail pharmacy chain, or convenient care clinic implementing the study

Primary outcomes:
measure: Non-intranasal steroid concomitant medication use
timeFrame: 3 months
Secondary outcomes:
measure: Concomitant Medication Cost
timeFrame: 3 months
measure: RCAT Score
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: