Condition category
Ear, Nose and Throat
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
07/12/2007
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

Dr George Lewith

ORCID ID

Contact details

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

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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes