A Comparison of Patients on AVAMYS ® Versus NASONEX (A Trade Mark of Schering Corporation) and FLIXONASE ® on Key Health Outcome Measures

NCT ID: NCT01199757

Last Updated: 2017-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

540 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-07-10

Study Completion Date

2009-08-01

Brief Summary

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Previous publications have indicated that Allergic Rhinitis (AR) patients suffering from both ocular and nasal symptoms have a greater burden of illness and lower quality of life than patients suffering from nasal symptoms alone. Fluticasone furoate (FF) acts against both nasal and ocular symptoms. The purpose of this study was to evaluate the differences in symptom control (both perceptually and objectively) and resource use for patients with current seasonal AR.

Detailed Description

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* Allergic rhinitis (AR) is a common inflammatory condition of the upper respiratory tract, nasal cavity and eyes affecting up to 20% of the population in the United States and Europe. The bothersome nature of AR symptoms can severely affect daily activities including ability to work and examination performance and impact on quality of life (QoL) and psychosocial well being.
* This study assesses the impact of Fluticasone furoate (FF) on the QoL of seasonal allergic rhinitis (SAR) patients, including the number of symptom-free days (SFD) and quality of life over the last 4 weeks, and compares this with other inhaled nasal steroids (INS): mometasone furate (MF) and fluticasone proprionate (FP).
* Selected physicians provide information including a range of demographic, symptom and treatment details for a number of their SAR patients. The patient themselves are then invited to provide details about their SAR including symptoms, the impact of AR upon their lifestyles, attitudes to treatment and completion of Health Related Quality of Life (HRQoL) instruments.

Conditions

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Rhinitis, Allergic, Perennial

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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FF

Cohort of patients receiving fluticasome furoate

Fluticasone furoate

Intervention Type DRUG

cohort of patients receiving fluticasone furate

MF

cohort of patients on mometasone furoate

mometasone furoate

Intervention Type DRUG

cohort receiving mometasone furoate

FP

cohort of patients receiving fluticasone propionate

fluticasone propionate

Intervention Type DRUG

cohort of patients on fluticasone propionate

Interventions

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Fluticasone furoate

cohort of patients receiving fluticasone furate

Intervention Type DRUG

mometasone furoate

cohort receiving mometasone furoate

Intervention Type DRUG

fluticasone propionate

cohort of patients on fluticasone propionate

Intervention Type DRUG

Other Intervention Names

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AVAMYS™ NASONEX™ FLIXONASE™

Eligibility Criteria

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Inclusion Criteria

* Current Seasonal Allergic Rhinitis sufferer (based on physician judgement)
* Currently receiving prescribed INS treatment (no other treatment restrictions apply)
* Have consumed at least one full prescription on the specified INS treatment
* No comorbid Asthma or COPD diagnosis
* Informed Consent

Exclusion Criteria

* None specified
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Adelphi Real World

INDUSTRY

Sponsor Role collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

References

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Higgins V, Kay S, Small M. Physician and patient survey of allergic rhinitis: methodology. Allergy. 2007;62 Suppl 85:6-8. doi: 10.1111/j.1398-9995.2007.01547.x.

Reference Type BACKGROUND
PMID: 17927672 (View on PubMed)

Gueron B; Demoly P; Piercy J; Small M. A comparison of patients on Avamys vs Nasonex and Flixonase for Quality of Life and Symptoms Free Days in 3 European countries [Poster 380]. Presented at: XXIXth Congress of the European Academy of Allergy and Clinical Immunology, June 2010, London

Reference Type RESULT

Small M, Piercy J, Demoly P, Marsden H. Burden of illness and quality of life in patients being treated for seasonal allergic rhinitis: a cohort survey. Clin Transl Allergy. 2013 Oct 9;3(1):33. doi: 10.1186/2045-7022-3-33.

Reference Type DERIVED
PMID: 24107462 (View on PubMed)

Other Identifiers

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114812

Identifier Type: -

Identifier Source: org_study_id

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