Evaluating the Need for New Rhinitis Treatment (MEDA)

Evaluating the Need for a New Combination Nasal Spray in the Treatment of Seasonal Rhinitis

The proposed study will evaluate the unmet therapy need in seasonal rhinitis by aiming to answer the following research questions

1. What is the first prescription of the hay-fever season and how many of these patients are on some form of combination therapy?
2. To what extent does initial therapy not meet clinical need (as measured by need for additional medical intervention in terms of consultations and changes in therapy)?
3. Does treatment for allergic rhinitis differ for asthma Vs non-asthma and seasonal Vs perennial patients?

Study Overview

• Status: Completed
• Conditions: Rhinitis

Detailed Description

Allergic rhinitis is a chronic respiratory disease with a major impact on quality of life. In a study looking at the burden of allergic rhinitis amongst UK patients 75% reported some impact of their allergic rhinitis symptoms on health-related quality of life. Allergic rhinitis currently affects 10-30% of the world population with prevalence and impact continuing to increase. This leads to substantial economic costs both of prescription medication and time taken off work by both patients and carers due to the disease. In view of this, there may be a substantial need for improved therapy or management to ensure that patients with allergic rhinitis can carry out a normal lifestyle.

The proposed study will evaluate the unmet therapy need in seasonal rhinitis by examining the current medication requirements of patients who suffer from seasonal grass-pollen hay fever and determining whether current therapies are sufficient for managing rhinitis.

This study aims to evaluate the unmet therapy need in seasonal rhinitis by -

1. Examining and describing current medication requirements
2. Quantifying the extent of co-prescribing of multiple agents
3. Comparing the effectiveness of current prescription drugs for managing and controlling patient's seasonal rhinitis and using changes in treatment during the hay fever season to determine the effectiveness of current therapy options.

for managing and controlling seasonal rhinitis in primary care patients who suffer from seasonal grass-pollen hay fever.

• Study Type: Observational
• Enrollment (Actual): 21203

Contacts and Locations

Study Locations

• United Kingdom
  • Cambridge, United Kingdom, CB24 3BA
    • Research in Real Life Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients will have seasonal rhinitis: defined as hay fever/rhinitis diagnosis during the hay fever season period and will be receiving therapy during the hay fever season

Description

Inclusion Criteria

The analysis will include patients who, at the index date, receive a therapy prescription for allergic rhinitis and have been diagnosed with a hay fever read code during their time at the practice. The following patients will be included within the study population:

(i)Patients receiving therapy: defined as those with a prescription for the increase or initiation of hay fever therapy during the hay fever season

(ii)Hay-fever code recorded ever

Exclusion criteria

(i)Patients taking maintenance oral steroids during the baseline period

(ii)Patients who only received LTRA during the study period and had already been receiving LTRA previously

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Persistent Patients; Defined as those with ≥1 treatment for allergic rhinitis in the six months preceding the IPD (defined as the first script of the hay fever season - May to August)
Seasonal Rhinitis; No treatment for allergic rhinitis in the six months preceding the IPD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Co-prescribing	The proportion of patients managed at the index prescription date with more than one class of therapy	31.11.12
Treatment Outcomes	For those patients who receive a prescription for a diagnosis of seasonal rhinitis/ hay fever. The following outcomes will be measured -; Patients who remain on the same therapy; Patients who change therapy within same therapy group; Patients who add additional therapy from another therapy group	10.12.12
Number of Consultations	Defined as a consultation where an allergic rhinitis read code or hay fever code is recorded during the hay fever season.	10.12.12
Asthma Patients - Exacerbations: Clinical	where exacerbation is defined as an occurrence of the following: a)Lower respiratory related : Hospital attendance/admission OR A & E attendance; OR Out-of-hours attendance; GP consultations for lower respiratory related tract infections;; Acute use of oral steroids .	10.12.12
Asthma Patients - Exacerbations: Severe	b)Asthma related - Hospital attendance/admission OR A & E attendance; OR Out-of-hours attendance; GP consultations for asthma related tract infections; Acute use of oral steroids	10.12.12
Costing Analysis	Descriptive analysis of costs at the first prescription and final prescription of the season. Comparing those who remain on same therapy and those who add therapy during the season.	15.01.13

Collaborators and Investigators

• Sponsor: Research in Real-Life Ltd
• Collaborators: Meda Pharmaceuticals
• Investigators: Principal Investigator: David Price, Prof, MD, University of Aberdeen

Publications and helpful links

General Publications

• Gupta R, Sheikh A, Strachan DP, Anderson HR. Burden of allergic disease in the UK: secondary analyses of national databases. Clin Exp Allergy. 2004 Apr;34(4):520-6. doi: 10.1111/j.1365-2222.2004.1935.x.
• Van Cauwenberge P, Van Hoecke H, Kardos P, Price D, Waserman S. The current burden of allergic rhinitis amongst primary care practitioners and its impact on patient management. Prim Care Respir J. 2009 Mar;18(1):27-33. doi: 10.3132/pcrj.2008.00042.
• Meltzer EO, Bukstein DA. The economic impact of allergic rhinitis and current guidelines for treatment. Ann Allergy Asthma Immunol. 2011 Feb;106(2 Suppl):S12-6. doi: 10.1016/j.anai.2010.10.014.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: June 7, 2013
• First Submitted That Met QC Criteria: June 7, 2013
• First Posted (Estimate): June 11, 2013

Study Record Updates

• Last Update Posted (Estimate): June 11, 2013
• Last Update Submitted That Met QC Criteria: June 7, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Rhinitis; Antihistamine; Nasal Steroid Therapy
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Nose Diseases; Rhinitis
• Other Study ID Numbers: R04412