Protocol Summary for 112602
| Protocol Id: | 112602 |
| Secondary Ids: |
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| Title: | Prospective Observational Study of Concomitant Allergic Rhinitis Treatment Patterns among Patients Starting on Fluticasone Furoate Nasal Spray in a Retail Pharmacy Setting |
| Phase: | phase 4 |
| Acronym: | |
| FDA Regulated Intervention?: | No |
| Section 801 Clinical Trial?: | |
| Delayed Posting: | |
| IND/IDE Protocol?: | no |
| Study Type: | Observational |
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| 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 furoate 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. |
| Detailed Description: | |
| Record Verification Date: | September 2011 |
| Status: | Terminated |
| Why Study Stopped: | Insufficient number of patient records met inclusion criteria |
| Study Start Date: | September 2010 |
| Study Completion Date: | September 2011 |
| Study Completion Date Type: | Actual |
| Primary Completion Date: | September 2011 |
| Primary Completion Date Type: | Actual |
| Study Design: | Cohort |
| Time Perspective: | Prospective |
| Biospecimen Retention: | None retained |
| Biospecimen Description: | |
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| Study Population: | Adult patients filling a new fluticasone furoate 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 intranasal 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. |
| Sampling Method: | Non probability |
| Eligibility Criteria: | 
Click to view inclusion/exclusion criteria
Inclusion Criteria: |
| Gender: | Both |
| Minimum Age: | 18 Year |
| Maximum Age: | |
| Enrollment: | 3 |
| Enrollment Type: | Actual |
| Healthy Volunteers?: | none |
| Central Contact: | Call Center |
| Central Contact Phone: | 877-379-3718 |
| Central Contact Email: | GSKClinicalSupportHD@gsk.com |
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| Overall Study Official: | GSK Clinical Trials |
| Overall Study Official Affiliation: | GlaxoSmithKline |
| Overall Study Official Role: | Study Director |
| Responsible Party Name/Official Title: | Cheri Hudson; Clinical Disclosure Advisor |
| Responsible Party Organization: | GSK Clinical Disclosure |
| Location and Contact Information: | No locations currently recruiting for this study. |