Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SEO131
Study information
Scientific title
Acronym
Study hypothesis
Is enzyme potentiated desensitisation significantly superior to an identical placebo treatment when administered pre-seasonally to hay fever sufferers?
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Seasonal rhinitis
Intervention
Patients randomised to receive two injections out of hay fever season, either EPD or placebo.
Intervention type
Drug
Phase
Not Specified
Drug names
Enzyme Potentiated Desensitisation (EPD)
Primary outcome measures
Measured during 12 week hay fever season: number of problem free days and post-treatment symptom scores.
Secondary outcome measures
No secondary outcome measures
Overall trial start date
14/05/2000
Overall trial end date
14/08/2001
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
240
Participant 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
Recruitment start date
14/05/2000
Recruitment end date
14/08/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Complementary Therapy Centre
Southampton
SO14 OYG
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive South East (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
Results in http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=18056902
Publication citations
-
Results
Williamson IG, Rumsby K, Benge S, Moore M, Smith PW, Cross M, Little P, Antibiotics and topical nasal steroid for treatment of acute maxillary sinusitis: a randomized controlled trial., JAMA, 2007, 298, 21, 2487-2496, doi: 10.1001/jama.298.21.2487.