Prospective Observational Study of Concomitant Allergic Rhinitis Treatment Patterns Among Patients Starting on Fluticasone Furoate Nasal Spray in a Retail Pharmacy Setting

NCT ID: NCT01337323

Last Updated: 2017-05-30

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 3 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2011-09-30

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.

Conditions

Rhinitis, Allergic, Seasonal; Seasonal Allergic Rhinitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

New prescription for fluticasone furoate nasal spray

patients receiving their first prescription for fluticasone furoate nasal spray and who have active seasonal allergic rhinitis with a history of using another intranasal steriod (INS) and other concomitant allergic rhinitis medications to treat their seasonal allergy symptoms.

Fluticasone furoate nasal spray

Intervention Type: DRUG

fluticasone furorate intranasal steroid spray

Interventions

Fluticasone furoate nasal spray

fluticasone furorate intranasal steroid spray

Intervention Type: DRUG

Other Intervention Names

Flonase® is a registered trademark of GlaxoSmithKline

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

112602

Identifier Type: -

Identifier Source: org_study_id