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Completed

NCT Number: NCT01875276

Evaluating the Need for New Rhinitis Treatment

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?

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Key information

Conditions

Rhinitis Infections Nose Diseases Otorhinolaryngologic Diseases Respiratory Tract Diseases Respiratory Tract Infections

Sex eligibility

All sexes

Study type

Observational

Primary location

Research in Real Life Ltd

Cambridge, CB24 3BA, United Kingdom

About this study

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 -

  • Examining and describing current medication requirements
  • Quantifying the extent of co-prescribing of multiple agents
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Co-prescribing

    Time frame: 31.11.12

    The proportion of patients managed at the index prescription date with more than one class of therapy

  2. Treatment Outcomes

    Time frame: 10.12.12

    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

  3. Number of Consultations

    Time frame: 10.12.12

    Defined as a consultation where an allergic rhinitis read code or hay fever code is recorded during the hay fever season.

  4. Asthma Patients - Exacerbations: Clinical

    Time frame: 10.12.12

    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 .

  5. Asthma Patients - Exacerbations: Severe

    Time frame: 10.12.12

    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

  6. Costing Analysis

    Time frame: 15.01.13

    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.

Sponsors and collaborators

Lead sponsor

Research in Real-Life Ltd

Network

Collaborators

  • Meda Pharmaceuticals

Registry information

Official study title

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

Acronym: MEDA

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jun 11, 2013
Registry last updated
Jun 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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