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

This study has been completed.
Sponsor:
Collaborator:
Adelphi Real World
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01199757
First received: September 9, 2010
Last updated: April 7, 2011
Last verified: January 2011

September 9, 2010
April 7, 2011
July 2009
August 2009   (final data collection date for primary outcome measure)
Evaluate the differences in Symtom Free Days (SFD) in patients receiving FF, MF or FP [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01199757 on ClinicalTrials.gov Archive Site
  • Evaluate the differences in Quality of Life (mini-Rhinoconjunctivitis Quality of Life Questionnaire) in patients receiving FF, MF or FP [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Evaluate the differences in the number of AR treatments used by patients receiving FF, MF or FP [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Evaluate the differences in the number of non-prescribed treatments used by patients receiving FF, MF or FP [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Evaluate the differences in the cost of non-prescribed treatments used by patients receiving FF, MF or FP [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Evaluate the differences in the Pittsburgh Sleep Quality Index in patients receiving FF, MF or FP [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Evaluate the differences in productivitiy (Work Productivity and Activity Impairment Questionnaire) of patients receiving FF, MF or FP [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Evaluate the differences in number of work day lost by patients receiving FF, MF or FP [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

  • 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.
Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Probability Sample

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.

  • Rhinitis, Allergic, Perennial
  • Rhinitis, Allergic, Seasonal
  • Drug: Fluticasone furoate
    cohort of patients receiving fluticasone furate
    Other Name: AVAMYS™
  • Drug: mometasone furoate
    cohort receiving mometasone furoate
    Other Name: NASONEX™
  • Drug: fluticasone propionate
    cohort of patients on fluticasone propionate
    Other Name: FLIXONASE™
  • FF
    Cohort of patients receiving fluticasome furoate
    Intervention: Drug: Fluticasone furoate
  • MF
    cohort of patients on mometasone furoate
    Intervention: Drug: mometasone furoate
  • FP
    cohort of patients receiving fluticasone propionate
    Intervention: Drug: fluticasone propionate
Higgins V, Kay S, Small M. Physician and patient survey of allergic rhinitis: methodology. Allergy. 2007;62 Suppl 85:6-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
540
August 2009
August 2009   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01199757
114812
No
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Adelphi Real World
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP