Condition category
Respiratory
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
11/10/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof David Price

ORCID ID

Contact details

Department of General Practice & Primary Care
University of Aberdeen
Foresterhill Health Centre
Westburn Road
Aberdeen
AB25 2AY
United Kingdom
+44 (0)1224 554588
david@respiratoryresearch.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 98/34/05

Study information

Scientific title

Acronym

ELEVATE

Study hypothesis

This study will evaluate the relative clinical effectiveness and costs at time points over a two year follow-up (short-term specifically at two months and long-term over two years) of Leukotriene Receptor Antagonist (LTRA) prescription in primary care.

PRIMARY: To compare quality of life with LTRAs against alternative treatments at steps two and three of the guidelines, comparing resource use over a two year period to the NHS and patients (on an intention to treat basis), using either a cost-minimisation or cost-effectiveness approach. The choice will depend on whether differences emerge between the groups over two years with particular emphasis on two months and two years (i.e. short and long-term).

SECONDARY: To compare other clinically relevant asthma outcomes between two treatment groups at two months and throughout the two year study (see Primary outcomes).

The design enables this to be compared at step two with inhaled steroid prescription and at step three with add-on of a long-acting beta agonist prescription. Its pragmatic design coupled with clinical trial rigour:
1. Concealed randomised allocation of patients,
2. Blinded procedures for recording and collection of outcomes data (by a non-clinician) and blinded data analysis should produce results that are both valid and applicable to primary care as a whole.

Please note that, as of 25 January 2008, the start and end dates of this trial were updated from 1 January 2000 and 30 April 2003 to 1 October 2001 and 28 February 2007, respectively.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Asthma

Intervention

LTRAs versus alternative treatment

Intervention type

Drug

Phase

Not Specified

Drug names

Leukotriene receptor antagonist

Primary outcome measures

1. Need for further treatment intervention
2. Frequency of exacerbations
3. Short-acting beta agonist use
4. Hospitalisations
5. Time off work
6. Daily inhaled steroid dose (step three)
7. Asthma symptoms
8. Morning and diurnal variation in peak flow
9. Those with eczema/rhinitis comparative change in disease assessment

Secondary outcome measures

Not provided at time of registration.

Overall trial start date

01/10/2001

Overall trial end date

28/02/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration.

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

720

Participant exclusion criteria

Not provided at time of registration.

Recruitment start date

01/10/2001

Recruitment end date

28/02/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of General Practice & Primary Care
Aberdeen
AB25 2AY
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/en/index.htm

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2010 Corticosteroid results in http://www.ncbi.nlm.nih.gov/pubmed/20550224
2. 2010 Beta-2 results in http://www.ncbi.nlm.nih.gov/pubmed/20446755
3. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21542741
4. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21554855

Publication citations

  1. Corticosteroid results

    Wilson EC, Sims EJ, Musgrave SD, Shepstone L, Blyth A, Murdoch J, Mugford HM, Juniper EF, Ayres JG, Wolfe S, Freeman D, Gilbert RF, Harvey I, Hillyer EV, Price D, Cost effectiveness of leukotriene receptor antagonists versus inhaled corticosteroids for initial asthma controller therapy: a pragmatic trial., Pharmacoeconomics, 2010, 28, 7, 585-595, doi: 10.2165/11537560-000000000-00000.

  2. Results

    Price D, Musgrave SD, Shepstone L, Hillyer EV, Sims EJ, Gilbert RF, Juniper EF, Ayres JG, Kemp L, Blyth A, Wilson EC, Wolfe S, Freeman D, Mugford HM, Murdoch J, Harvey I, Leukotriene antagonists as first-line or add-on asthma-controller therapy., N. Engl. J. Med., 2011, 364, 18, 1695-1707, doi: 10.1056/NEJMoa1010846.

  3. Results

    Price D, Musgrave S, Wilson E, Sims E, Shepstone L, Blyth A, Murdoch J, Mugford M, Juniper E, Ayres J, Wolfe S, Freeman D, Lipp A, Gilbert R, Harvey I, A pragmatic single-blind randomised controlled trial and economic evaluation of the use of leukotriene receptor antagonists in primary care at steps 2 and 3 of the national asthma guidelines (ELEVATE study)., Health Technol Assess, 2011, 15, 21, 1-132, doi: 10.3310/hta15210.

  4. Wilson EC, Price D, Musgrave SD, Sims EJ, Shepstone L, Murdoch J, Mugford HM, Blyth A, Juniper EF, Ayres JG, Wolfe S, Freeman D, Gilbert RF, Hillyer EV, Harvey I, Cost effectiveness of leukotriene receptor antagonists versus long-acting beta-2 agonists as add-on therapy to inhaled corticosteroids for asthma: a pragmatic trial., Pharmacoeconomics, 2010, 28, 7, 597-608, doi: 10.2165/11537550-000000000-00000.

Additional files

Editorial Notes