Evaluating the Need for New Rhinitis Treatment

NCT01875276 | Completed

• 1 other identifier: R04412
• Study Type: observational
• Target: 21,203
• Locations: 1 country
• Sites: 1

Brief Summary

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

1. 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. 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. 3.Does treatment for allergic rhinitis differ for asthma Vs non-asthma and seasonal Vs perennial patients?

Conditions

Rhinitis

Keywords

Rhinitis; Antihistamine; Nasal Steroid Therapy

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• (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

Sponsors & Collaborators

• Research in Real-Life Ltd: lead
• Meda Pharmaceuticals: collaborator

Study Sites (1)

Research in Real Life Ltd

Cambridge, CB24 3BA, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 15080802 BACKGROUND

• 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.

  PMID: 18622524 RESULT

• 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.

  PMID: 21277528 RESULT

MeSH Terms

Conditions

Rhinitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• David Price, Prof, MD

  University of Aberdeen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor David Price

Study Record Dates

• First Submitted: June 7, 2013
• First Posted: June 11, 2013
• Study Start: January 1, 2013
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: June 11, 2013

Record last verified: 2013-06

Locations

GB (1)