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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

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
History of Changes
  Purpose

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.


Condition Intervention
Rhinitis, Allergic, Perennial
Rhinitis, Allergic, Seasonal
 Drug: Fluticasone furoate
Drug: mometasone furoate
Drug: fluticasone propionate

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: A Comparison of Patients on AVAMYS ® Versus NASONEX (A Trade Mark of Schering Corporation) and FLIXONASE ® on Key Health Outcome Measures

Resource links provided by NLM:

MedlinePlus related topics: Hay Fever
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Evaluate the differences in Symtom Free Days (SFD) in patients receiving FF, MF or FP [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 540
Study Start Date: July 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
FF
Cohort of patients receiving fluticasome furoate
 Drug: Fluticasone furoate
cohort of patients receiving fluticasone furate
Other Name: AVAMYS™
MF
cohort of patients on mometasone furoate
 Drug: mometasone furoate
cohort receiving mometasone furoate
Other Name: NASONEX™
FP
cohort of patients receiving fluticasone propionate
 Drug: fluticasone propionate
cohort of patients on fluticasone propionate
Other Name: FLIXONASE™

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.
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01199757

Sponsors and Collaborators
GlaxoSmithKline
Adelphi Real World
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01199757     History of Changes
Other Study ID Numbers: 114812
Study First Received: September 9, 2010
Last Updated: April 7, 2011
Health Authority: Europe: European Pharmaceutical Market Research Association

Keywords provided by GlaxoSmithKline:
ocular symptoms
nasal symptoms
Allergic Rhinitis
Symptom Free Days
Quality of Life

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Mometasone furoate
 Fluticasone
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on May 19, 2013