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ISRCTN
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ISRCTN60825437
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ClinicalTrials.gov identifier
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Public title
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A double blind randomised placebo controlled study to evaluate the efficacy of Enzyme Potentiated Desensitisation (EPD) in seasonal rhinitis
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Scientific title
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Acronym
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N/A
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Serial number at source
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SEO131
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Study hypothesis
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Is enzyme potentiated desensitisation significantly superior to an identical placebo treatment when administered pre-seasonally to hay fever sufferers?
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Ethics approval
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The study was approved by the Southwest England Multicentre Research Ethics Committee (MREC) and several local research ethics committees.
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Seasonal rhinitis
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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14/05/2000
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Anticipated end date
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14/08/2001
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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240
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Interventions
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Patients randomised to receive two injections out of hay fever season, either EPD or placebo.
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Primary outcome measure(s)
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Measured during 12 week hay fever season: number of problem free days and post-treatment symptom scores.
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Secondary outcome measure(s)
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No secondary outcome measures
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Sources of funding
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NHS Executive South East (UK)
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Trial website
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Publications
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Results in http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=18056902
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Contact name
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Dr
George
Lewith
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Address
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Complementary Therapy Centre
Royal South Hants Hospital
Brintons Terrace
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City/town
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Southampton
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Zip/Postcode
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SO14 OYG
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Country
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United Kingdom
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Sponsor
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NHS R&D Regional Programme Register - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.doh.gov.uk
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Date applied
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23/01/2004
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Last edited
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07/12/2007
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Date ISRCTN assigned
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23/01/2004
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