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

This study has been terminated.
(Insufficient number of patient records met inclusion criteria)
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01337323
First received: April 15, 2011
Last updated: February 15, 2013
Last verified: February 2013
  Purpose

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 Intervention
Rhinitis, Allergic, Seasonal
Seasonal Allergic Rhinitis
Drug: Fluticasone furoate nasal spray

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Observational Study of Concomitant Allergic Rhinitis Treatment Patterns Among Patients Starting on Fluticasone Furoate Nasal Spray in a Retail Pharmacy Setting

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Non-intranasal steroid concomitant medication use [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    change in rate of non-intranasal steroid concomitant medication use (frequency and duration)


Secondary Outcome Measures:
  • Concomitant Medication Cost [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Change in total allergic rhinitis pharmacy expenditures

  • RCAT Score [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Level of control of allergic rhinitis, as measured by score on the Rhinitis Control Assessment Test (RCAT)


Enrollment: 3
Study Start Date: September 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01337323

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01337323     History of Changes
Other Study ID Numbers: 112602
Study First Received: April 15, 2011
Last Updated: February 15, 2013
Health Authority: United States: Food and Drug Administration
United States: No Health Authority

Keywords provided by GlaxoSmithKline:
allergic rhinitis, allergies, concomitant medications, allergy symptoms

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Fluticasone
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 16, 2014