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
• First Posted: April 18, 2011
• Last Update Posted: May 30, 2017
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

Tracking Information

• First Submitted Date: April 15, 2011
• First Posted Date: April 18, 2011
• Last Update Posted Date: May 30, 2017
• Study Start Date: September 2010
• Actual Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 15, 2013)

Non-intranasal steroid concomitant medication use [ Time Frame: 3 months ]

change in rate of non-intranasal steroid concomitant medication use (frequency and duration)

Original Primary Outcome Measures (submitted: April 15, 2011)

Concomitant medication Use [ Time Frame: 3 months ]

Rate of use of non-INS concomitant medications (frequency and duration) and change in rate of use of non-INS concomitant medications

Current Secondary Outcome Measures (submitted: April 15, 2011)

• 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)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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

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.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.

Condition

• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

Drug: Fluticasone furoate nasal spray

fluticasone furorate intranasal steroid spray

Other Name: Flonase® is a registered trademark of GlaxoSmithKline

Study Groups/Cohorts

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.

Intervention: Drug: Fluticasone furoate nasal spray

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: February 15, 2013): 3
• Original Estimated Enrollment (submitted: April 15, 2011): 1
• Actual Study Completion Date: September 2011
• Actual Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT01337323
• Other Study ID Numbers: 112602
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: GlaxoSmithKline
• Original Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
• Current Study Sponsor: GlaxoSmithKline
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

• PRS Account: GlaxoSmithKline
• Verification Date: May 2017