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

Rhinitis, Allergic, Perennial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01199757
• Other study ID #: 114812
• Status: Completed
• Phase: N/A
• First received: September 9, 2010
• Last updated: August 11, 2017
• Start date: July 10, 2009
• Est. completion date: August 1, 2009

Study information

• Verified date: August 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 540
• Est. completion date: August 1, 2009
• Est. primary completion date: August 1, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Perennial

Intervention

Drug:
• Fluticasone furoate
cohort of patients receiving fluticasone furate
• mometasone furoate
cohort receiving mometasone furoate
• fluticasone propionate
cohort of patients on fluticasone propionate

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
GlaxoSmithKline	Adelphi Real World

References & Publications (2)

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 Clinic

Higgins V, Kay S, Small M. Physician and patient survey of allergic rhinitis: methodology. Allergy. 2007;62 Suppl 85:6-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the differences in Symtom Free Days (SFD) in patients receiving FF, MF or FP		4 weeks
Secondary	Evaluate the differences in Quality of Life (mini-Rhinoconjunctivitis Quality of Life Questionnaire) in patients receiving FF, MF or FP		4 weeks
Secondary	Evaluate the differences in the number of AR treatments used by patients receiving FF, MF or FP		4 weeks
Secondary	Evaluate the differences in the number of non-prescribed treatments used by patients receiving FF, MF or FP		4 weeks
Secondary	Evaluate the differences in the cost of non-prescribed treatments used by patients receiving FF, MF or FP		4 weeks
Secondary	Evaluate the differences in the Pittsburgh Sleep Quality Index in patients receiving FF, MF or FP		4 weeks
Secondary	Evaluate the differences in productivitiy (Work Productivity and Activity Impairment Questionnaire) of patients receiving FF, MF or FP		4 weeks
Secondary	Evaluate the differences in number of work day lost by patients receiving FF, MF or FP		4 weeks
Secondary	Evaluate the differences in the number of physician visits (as reported by patient and doctor) by patients receiving FF, MF or FP		4 weeks