Prospective Observational Study of Concomitant Allergic Rhinitis Treatment Patterns Among Patients Starting on Fluticasone Furoate Nasal Spray in a Retail Pharmacy Setting
|ClinicalTrials.gov Identifier: NCT01337323|
Recruitment Status : Terminated (Insufficient number of patient records met inclusion criteria)
First Posted : April 18, 2011
Last Update Posted : May 30, 2017
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.
|Condition or disease||Intervention/treatment|
|Rhinitis, Allergic, Seasonal Seasonal Allergic Rhinitis||Drug: Fluticasone furoate nasal spray|
|Study Type :||Observational|
|Actual Enrollment :||3 participants|
|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 Start Date :||September 2010|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||September 2011|
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.
Drug: Fluticasone furoate nasal spray
fluticasone furorate intranasal steroid spray
Other Name: Flonase® is a registered trademark of GlaxoSmithKline
- Non-intranasal steroid concomitant medication use [ Time Frame: 3 months ]change in rate of non-intranasal steroid concomitant medication use (frequency and duration)
- Concomitant Medication Cost [ Time Frame: 3 months ]Change in total allergic rhinitis pharmacy expenditures
- RCAT Score [ Time Frame: 3 months ]Level of control of allergic rhinitis, as measured by score on the Rhinitis Control Assessment Test (RCAT)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01337323
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|