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

NCT01199757 | Completed

• 1 other identifier: 114812
• Study Type: observational
• Target: 540
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rhinitis, Allergic, Perennial

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  4 weeks

Secondary Outcomes (8)

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

  4 weeks

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

  4 weeks

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

  4 weeks

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

  4 weeks

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

  4 weeks

Study Arms (3)

FF

Cohort of patients receiving fluticasome furoate

Drug: Fluticasone furoate

MF

cohort of patients on mometasone furoate

Drug: mometasone furoate

FP

cohort of patients receiving fluticasone propionate

Drug: fluticasone propionate

Interventions

Fluticasone furoate DRUG

cohort of patients receiving fluticasone furate

Also known as: AVAMYS™

FF

mometasone furoate DRUG

cohort receiving mometasone furoate

Also known as: NASONEX™

MF

fluticasone propionate DRUG

cohort of patients on fluticasone propionate

Also known as: FLIXONASE™

FP

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• None specified

Sponsors & Collaborators

• GlaxoSmithKline: lead
• Adelphi Real World: collaborator

Related Publications (3)

• Higgins V, Kay S, Small M. Physician and patient survey of allergic rhinitis: methodology. Allergy. 2007;62 Suppl 85:6-8. doi: 10.1111/j.1398-9995.2007.01547.x.

  PMID: 17927672 BACKGROUND

• Gueron B; Demoly P; Piercy J; Small M. A comparison of patients on Avamys vs Nasonex and Flixonase for Quality of Life and Symptoms Free Days in 3 European countries [Poster 380]. Presented at: XXIXth Congress of the European Academy of Allergy and Clinical Immunology, June 2010, London

  RESULT

• Small M, Piercy J, Demoly P, Marsden H. Burden of illness and quality of life in patients being treated for seasonal allergic rhinitis: a cohort survey. Clin Transl Allergy. 2013 Oct 9;3(1):33. doi: 10.1186/2045-7022-3-33.

  PMID: 24107462 DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial; Rhinitis, Allergic

Interventions

fluticasone furoate; Mometasone Furoate; Fluticasone

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Androstadienes; Androstenes; Androstanes

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2010
• First Posted: September 13, 2010
• Study Start: July 10, 2009
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: August 14, 2017

Record last verified: 2017-08