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

Seasonal Allergic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01337323
• Other study ID #: 112602
• Status: Terminated
• Phase: N/A
• First received: April 15, 2011
• Last updated: May 25, 2017
• Start date: September 2010
• Est. completion date: September 2011

Study information

• Verified date: May 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

Drug:
• Fluticasone furoate nasal spray
fluticasone furorate intranasal steroid spray

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-intranasal steroid concomitant medication use	change in rate of non-intranasal steroid concomitant medication use (frequency and duration)	3 months
Secondary	Concomitant Medication Cost	Change in total allergic rhinitis pharmacy expenditures	3 months
Secondary	RCAT Score	Level of control of allergic rhinitis, as measured by score on the Rhinitis Control Assessment Test (RCAT)	3 months