Evaluating the Need for New Rhinitis Treatment

NCT ID: NCT01875276

Last Updated: 2013-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

21203 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-03-31

Brief Summary

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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?

Detailed Description

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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.

Conditions

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Rhinitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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)

No interventions assigned to this group

Seasonal Rhinitis

No treatment for allergic rhinitis in the six months preceding the IPD

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meda Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Research in Real-Life Ltd

NETWORK

Sponsor Role lead

Responsible Party

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David Price, Prof., MD

Professor David Price

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Price, Prof, MD

Role: PRINCIPAL_INVESTIGATOR

University of Aberdeen

Locations

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Research in Real Life Ltd

Cambridge, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 15080802 (View on PubMed)

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.

Reference Type RESULT
PMID: 18622524 (View on PubMed)

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.

Reference Type RESULT
PMID: 21277528 (View on PubMed)

Other Identifiers

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R04412

Identifier Type: -

Identifier Source: org_study_id

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