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

August 11, 2017 updated by: GlaxoSmithKline
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

540

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Inclusion criteria for physicians:

  • Qualified after 1965
  • See 3 or more AR patients per week
  • Personally responsible for treatment decisions for patients with AR

  • Gave consent to participate to complete all tasks for the study duration

    90 Primary Care Physicians and 45 allergists, each prospectively recruit 4 consecutive patients with SAR who provided consent to participate, for a total of 540 patients. Each physician completed a patient record form for 2 patients on fluticasone furate, 1 patient on mometasone furate and 1 patient on fluticasone propionate.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
FF
Cohort of patients receiving fluticasome furoate
Drug: Fluticasone furoate
cohort of patients receiving fluticasone furate
Other Names:
  • AVAMYS™
MF
cohort of patients on mometasone furoate
Drug: mometasone furoate
cohort receiving mometasone furoate
Other Names:
  • NASONEX™
FP
cohort of patients receiving fluticasone propionate
Drug: fluticasone propionate
cohort of patients on fluticasone propionate
Other Names:
  • FLIXONASE™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluate the differences in Symtom Free Days (SFD) in patients receiving FF, MF or FP
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate the differences in Quality of Life (mini-Rhinoconjunctivitis Quality of Life Questionnaire) in patients receiving FF, MF or FP
Time Frame: 4 weeks
4 weeks
Evaluate the differences in the number of AR treatments used by patients receiving FF, MF or FP
Time Frame: 4 weeks
4 weeks
Evaluate the differences in the number of non-prescribed treatments used by patients receiving FF, MF or FP
Time Frame: 4 weeks
4 weeks
Evaluate the differences in the cost of non-prescribed treatments used by patients receiving FF, MF or FP
Time Frame: 4 weeks
4 weeks
Evaluate the differences in the Pittsburgh Sleep Quality Index in patients receiving FF, MF or FP
Time Frame: 4 weeks
4 weeks
Evaluate the differences in productivitiy (Work Productivity and Activity Impairment Questionnaire) of patients receiving FF, MF or FP
Time Frame: 4 weeks
4 weeks
Evaluate the differences in number of work day lost by patients receiving FF, MF or FP
Time Frame: 4 weeks
4 weeks
Evaluate the differences in the number of physician visits (as reported by patient and doctor) by patients receiving FF, MF or FP
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Collaborators

Adelphi Real World

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2009

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

September 9, 2010

First Submitted That Met QC Criteria

September 9, 2010

First Posted (Estimate)

September 13, 2010

Study Record Updates

Last Update Posted (Actual)

August 14, 2017

Last Update Submitted That Met QC Criteria

August 11, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 114812

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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