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OpenTrials
Completed

NCT Number: NCT01199757

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

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.

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Key information

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluticasone Furoate

Drug

cohort of patients receiving fluticasone furate

Other names: AVAMYS™

Mometasone furoate

Drug

cohort receiving mometasone furoate

Other names: NASONEX™

Fluticasone propionate

Drug

cohort of patients on fluticasone propionate

Other names: FLIXONASE™

Primary outcomes

  1. Evaluate the differences in Symtom Free Days (SFD) in patients receiving FF, MF or FP

    Time frame: 4 weeks

Secondary outcomes

  1. Evaluate the differences in Quality of Life (mini-Rhinoconjunctivitis Quality of Life Questionnaire) in patients receiving FF, MF or FP

    Time frame: 4 weeks

  2. Evaluate the differences in the number of AR treatments used by patients receiving FF, MF or FP

    Time frame: 4 weeks

  3. Evaluate the differences in the number of non-prescribed treatments used by patients receiving FF, MF or FP

    Time frame: 4 weeks

  4. Evaluate the differences in the cost of non-prescribed treatments used by patients receiving FF, MF or FP

    Time frame: 4 weeks

  5. Evaluate the differences in the Pittsburgh Sleep Quality Index in patients receiving FF, MF or FP

    Time frame: 4 weeks

  6. Evaluate the differences in productivitiy (Work Productivity and Activity Impairment Questionnaire) of patients receiving FF, MF or FP

    Time frame: 4 weeks

  7. Evaluate the differences in number of work day lost by patients receiving FF, MF or FP

    Time frame: 4 weeks

  8. 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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Collaborators

  • Adelphi Real World

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Sep 13, 2010
Registry last updated
Aug 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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