A double blind randomised placebo controlled study to evaluate the efficacy of Enzyme Potentiated Desensitisation (EPD) in seasonal rhinitis

ISRCTN	ISRCTN60825437
DOI	https://doi.org/10.1186/ISRCTN60825437
Secondary identifying numbers	SEO131

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr George Lewith
Scientific

Complementary Therapy Centre
Royal South Hants Hospital
Brintons Terrace
Southampton
SO14 OYG
United Kingdom

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study objectives	Is enzyme potentiated desensitisation significantly superior to an identical placebo treatment when administered pre-seasonally to hay fever sufferers?
Ethics approval(s)	The study was approved by the Southwest England Multicentre Research Ethics Committee (MREC) and several local research ethics committees.
Health condition(s) or problem(s) studied	Seasonal rhinitis
Intervention	Patients randomised to receive two injections out of hay fever season, either EPD or placebo.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Enzyme Potentiated Desensitisation (EPD)
Primary outcome measure	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 study start date	14/05/2000
Completion date	14/08/2001

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	240
Key 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
Key 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
Date of first enrolment	14/05/2000
Date of final enrolment	14/08/2001

Complementary Therapy Centre

Southampton
SO14 OYG
United Kingdom

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Government

NHS Executive South East (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	05/12/2007		Yes	No