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
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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01171664 -
Clinical Trial of STAHIST in Seasonal Allergic Rhinitis (SAR) Subjects
|
Phase 2 | |
| Completed |
NCT00784732 -
A Study to Compare the Efficacy of QAV680 Against Placebo in Treating Seasonal Allergic Rhinitis in an Environmental Exposure Chamber
|
Phase 2 | |
| Completed |
NCT00619827 -
Efficacy and Safety of Sublingual Tablets of Grass Pollen Allergen Extract
|
Phase 1 | |
| Completed |
NCT00578929 -
Safety and Efficacy of Olopatadine HCl Nasal Spray in 6-11 Year Old Patients
|
Phase 3 | |
| Completed |
NCT00209365 -
The Role of Pollen Starch Granules in Pollen Challenge Studies in the Fraunhofer Environmental Exposure Unit
|
N/A | |
| Terminated |
NCT00223587 -
Seasonal Allergic Rhinitis and Driving Ability
|
Phase 4 | |
| Completed |
NCT00637455 -
Single Center, Randomized, Double-Blind,Crossover Study Comparing Effects Of Single-Dose Fexofenadine HCl 180 mg, Cetirizine 10 mg, and Placebo on Cognitive Performance in Naval Flight Personnel
|
Phase 4 | |
| Completed |
NCT00963599 -
Montelukast in Seasonal Allergic Rhinitis - Fall 1999 Study (0476A-117)
|
Phase 3 | |
| Recruiting |
NCT05346718 -
Threshold Concentrations for Ragweed and Birch Pollen in Seasonal Allergic Rhinitis
|
N/A | |
| Completed |
NCT06126952 -
Azelastine Allergen Chamber - Onset of Action Study
|
Phase 2 | |
| Completed |
NCT02245360 -
Study Immunology and Safety of 60-day Treatment of SQ Grass SLIT (Sublingual Immunotherapy)-Tablet in Adult Subjects With Grass Pollen-induced Allergic Rhinoconjunctivitis
|
Phase 3 | |
| Completed |
NCT01940146 -
Efficacy and Safety of SPARC1310 in Seasonal Allergic Rhinitis
|
Phase 2 | |
| Completed |
NCT01230619 -
Vienna Challenge Chamber Study Using RV658 in Subjects With Allergic Rhinitis
|
Phase 2 | |
| Completed |
NCT00561717 -
A Randomized, Placebo Controlled Study to Determine the Efficacy and Speed of a Nasal Spray in Allergen Induced Seasonal Allergic Rhinitis
|
Phase 4 | |
| Completed |
NCT00574210 -
PK/PD and Steady State Efficacy Study of Bilastine Compared With Placebo Given Orally in the Treatment of the Symptoms of SAR in an EEC Model (5-arm)
|
Phase 2 | |
| Completed |
NCT00420082 -
A Randomized, Double-Blind, 4-way Crossover Study to Evaluate the Efficacy of Bilastine in the Vienna Challenge Chamber
|
Phase 2 | |
| Completed |
NCT00405899 -
Pilot Study of Allergy Immunotherapy and Prevention of Viral Respiratory Infections
|
N/A | |
| Completed |
NCT00443495 -
Phase I/IIa Study on Chitin Microparticles in Subjects Suffering From Allergic Rhinitis
|
Phase 1/Phase 2 | |
| Completed |
NCT03097432 -
Non-interventional Study to Assess the Tolerability, the Safety Profile and the Adherence of Different Up-dosing Schemes for a Sublingual Immunotherapy Treatment
|
N/A | |
| Completed |
NCT05540717 -
Efficacy and Safety of PQ Grass in Subjects With Seasonal Allergic Rhinitis and/or Rhinoconjunctivitis Induced by Grass Pollen
|
Phase 3 |