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A double blind randomised placebo controlled study to evaluate the efficacy of Enzyme Potentiated Desensitisation (EPD) in seasonal rhinitis
ISRCTN ISRCTN60825437
DOI 10.1186/ISRCTN60825437
ClinicalTrials.gov identifier
EudraCT number
Public title A double blind randomised placebo controlled study to evaluate the efficacy of Enzyme Potentiated Desensitisation (EPD) in seasonal rhinitis
Scientific title
Acronym N/A
Serial number at source SEO131
Study hypothesis Is enzyme potentiated desensitisation significantly superior to an identical placebo treatment when administered pre-seasonally to hay fever sufferers?
Lay summary
Ethics approval The study was approved by the Southwest England Multicentre Research Ethics Committee (MREC) and several local research ethics committees.
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Seasonal rhinitis
Participants - inclusion criteria 1. To be recruited from GP lists aged 18 - 64 years
2. Either sex
3. History of seasonal allergic rhinitis extending mid-May to end-July
4. Positive skin prick test to mixed grass pollens
Participants - exclusion criteria 1. Symptoms of sufficient severity to require regular treatment outside usual grass-pollinating season
2. History of predominant seasonal problem not corresponding with usual grass-pollinating season
3. Rhinitis complicated by nasal infection, rhino-sinusitis, nasal polyps, septal deviation, gross turbinate hypertrophy or intranasal mass
4. History of anaphylaxis or laryngeal oedema
5. Undergoing nasal surgery within 2 months
6. Receiving specific immunotherapy (high dose method) within preceeding 12 months
Anticipated start date 14/05/2000
Anticipated end date 14/08/2001
Status of trial Completed
Patient information material
Target number of participants 240
Interventions Patients randomised to receive two injections out of hay fever season, either EPD or placebo.
Primary outcome measure(s) Measured during 12 week hay fever season: number of problem free days and post-treatment symptom scores.
Secondary outcome measure(s) No secondary outcome measures
Sources of funding NHS Executive South East (UK)
Trial website
Publications Results in http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=18056902
Contact name Dr  George  Lewith
  Address Complementary Therapy Centre
Royal South Hants Hospital
Brintons Terrace
  City/town Southampton
  Zip/Postcode SO14 OYG
  Country United Kingdom
Sponsor NHS R&D Regional Programme Register - Department of Health (UK)
  Address The Department of Health
Richmond House
79 Whitehall
  City/town London
  Zip/Postcode SW1A 2NL
  Country United Kingdom
  Tel +44 (0) 20 7307 2622
  Fax +44 (0) 20 7307 2623
  Email dhmail@doh.gsi.org.uk
  Sponsor website: http://www.doh.gov.uk
Date applied 23/01/2004
Last edited 07/12/2007
Date ISRCTN assigned 23/01/2004
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