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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01199757
Enrollment
540
Registered
2010-09-13
Start date
2009-07-10
Completion date
2009-08-01
Last updated
2017-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rhinitis, Allergic, Perennial

Keywords

ocular symptoms, nasal symptoms, Allergic Rhinitis, Symptom Free Days, Quality of Life

Brief summary

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

* 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.

Interventions

DRUGFluticasone furoate

cohort of patients receiving fluticasone furate

DRUGmometasone furoate

cohort receiving mometasone furoate

DRUGfluticasone propionate

cohort of patients on fluticasone propionate

Sponsors

Adelphi Real World
CollaboratorINDUSTRY
GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

Patient 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

Design outcomes

Primary

MeasureTime frame
Evaluate the differences in Symtom Free Days (SFD) in patients receiving FF, MF or FP4 weeks

Secondary

MeasureTime frame
Evaluate the differences in the number of AR treatments used by patients receiving FF, MF or FP4 weeks
Evaluate the differences in the number of non-prescribed treatments used by patients receiving FF, MF or FP4 weeks
Evaluate the differences in the cost of non-prescribed treatments used by patients receiving FF, MF or FP4 weeks
Evaluate the differences in Quality of Life (mini-Rhinoconjunctivitis Quality of Life Questionnaire) in patients receiving FF, MF or FP4 weeks
Evaluate the differences in productivitiy (Work Productivity and Activity Impairment Questionnaire) of patients receiving FF, MF or FP4 weeks
Evaluate the differences in number of work day lost by patients receiving FF, MF or FP4 weeks
Evaluate the differences in the number of physician visits (as reported by patient and doctor) by patients receiving FF, MF or FP4 weeks
Evaluate the differences in the Pittsburgh Sleep Quality Index in patients receiving FF, MF or FP4 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026