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 |
| Protocol serial number | SEO131 |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive South East (UK) |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 07/12/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Ear, Nose and Throat
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr George Lewith
Scientific
Scientific
Complementary Therapy Centre
Royal South Hants Hospital
Brintons Terrace
Southampton
SO14 OYG
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Enzyme Potentiated Desensitisation (EPD) |
| Primary outcome measure(s) |
Measured during 12 week hay fever season: number of problem free days and post-treatment symptom scores. |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 14/08/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- United Kingdom
Study participating centre
Complementary Therapy Centre
Southampton
SO14 OYG
United Kingdom
SO14 OYG
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 05/12/2007 | Yes | No |
