Clinical trial NCT01875276: Evaluating the Need for New Rhinitis Treatment
Official title: Evaluating the Need for a New Combination Nasal Spray in the Treatment of Seasonal Rhinitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rhinitis
Keywords: Rhinitis
Antihistamine
Nasal Steroid Therapy
Lead sponsor: Research in Real-Life Ltd
Sponsor class: NETWORK
Collaborators: name: Meda Pharmaceuticals
First posted: 2013-06-11
Enrollment: 21203
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Co-prescribing
timeFrame: 31.11.12
measure: Treatment Outcomes
timeFrame: 10.12.12
measure: Number of Consultations
timeFrame: 10.12.12
measure: Asthma Patients - Exacerbations: Clinical
timeFrame: 10.12.12
measure: Asthma Patients - Exacerbations: Severe
timeFrame: 10.12.12
measure: Costing Analysis
timeFrame: 15.01.13
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Research in Real Life Ltd
Study officials:
affiliation: University of Aberdeen
name: David Price, Prof, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.