Condition category
Respiratory
Date applied
19/11/2012
Date assigned
19/11/2012
Last edited
19/11/2012
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 Stephen Till

ORCID ID

Contact details

King's College London
Department of Asthma
St. Thomas Street
London
SE1 9RT
United Kingdom
stephen.till@kcl.ac.uk

Additional identifiers

EudraCT number

2012-002193-31

ClinicalTrials.gov number

Protocol/serial number

12950

Study information

Scientific title

A randomised, double-blind, single-centre, controlled trial of low dose intradermal allergen immunotherapy in adults with seasonal allergic rhinitis

Acronym

PollenLITE

Study hypothesis

We are performing a clinical trial of a new vaccine treatment for hay fever, which affects 1 in 4 people in the UK. Injection of small quantities of grass pollen high up in the skin (in an area called the dermis) provokes a local allergic response, visible as a lump lasting a day or two. When these injections are repeated every 2 weeks, a dramatic reduction is seen in the size of this lump, suggesting that the allergic reactions are being switched off. Our aim is now to test if this also switches off grass allergy in the nose and improves hay fever symptoms. A clinical trial will be performed at Guy’s Hospital in 2013, with 90 hay fever sufferers divided into 2 groups to receive between 7 and 8 injections of grass pollen into the dermis, or similar dummy injections, before the grass pollen season. In the summer, participants will score their symptoms and how much hay fever medication they need. We will then compare these scores in the 2 groups. We will also perform experiments to see how this ‘vaccine’ might work: we take blood samples at the beginning and end of the study for experiments. Also, we will collect a small sample of skin, but only from 40 of the participants selected at random, although they will free to decline this. We will also perform tests to examine if the effect of the vaccine is long lasting. We believe that these injections are safe, although we will observe all participants for 1 hour after the first injection and for 30 minutes after subsequent injections. This study also has the potential to define a new scientific and clinical principle that could also be applied to other allergic diseases e.g. asthma and food allergies.

More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=12950

Ethics approval

First MREC, 25 July 2012 ref: 12/LO/0941

Study design

Randomised interventional trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Respiratory disease

Intervention

Intradermal Injecitons, Active: Grass Pollen extract
Control: Histamine; Follow Up Length: 24 months

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Combined symptom/medication score measured at summer 2013

Secondary outcome measures

No secondary outcome measures

Overall trial start date

20/09/2012

Overall trial end date

21/03/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adults aged 18 to 65 years
2. A clinical history of grass pollen-induced allergic rhinoconjunctivitis for at least 2 years with peak symptoms in May, June, or July.
3. A clinical history of moderate-severe persistent rhinoconjunctivitis symptoms interfering with usual daily activities or with sleep.
4. A clinical history of rhinoconjunctivitis that remains troublesome despite treatment with either antihistamines or nasal corticosteroids during the grass pollen season.
5. Positive skin prick test response, defined as wheal diameter greater than or equal to 3 mm, to Phleum pratense.
6. Positive specific IgE, defined as greater than or equal to IgE class 2, against Phleum pratense.
7. For women of childbearing age, a willingness to use an effective form of contraception for the duration of intradermal injections.
8. The ability to give informed consent and comply with study procedures
9. Male or female

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

UK Sample Size: 90; Description: 45 active, 45 control

Participant exclusion criteria

1. Pre-bronchodilator FEV1 less than 70% of predicted value at screening visit
2. A history of seasonal grass pollen-induced asthma requiring regular treatment with salbutamol or inhaled corticosteroids. Patients with mild seasonal grass pollen-induced asthma may be included, provided symptoms are satisfactorily controlled with occasional salbutamol only.
3. A clinical history of symptomatic seasonal allergic rhinitis and/or asthma due to tree pollen or weed pollen near or overlapping the grass pollen season.
4. A clinical history of symptomatic allergic rhinitis and/or asthma caused by a perennial allergen to which the participant is regularly exposed.
5. Emergency department visit or hospital admission for asthma in the previous 12 months.
6. History of chronic obstructive pulmonary disease.
7. History of significant recurrent acute sinusitis, defined as 2 episodes per year for the last 2 years, all of which required antibiotic treatment.
8. History of chronic sinusitis, defined as a sinus symptoms lasting greater than 12 weeks that includes 2 or more major factors or 1 major factor and 2 minor factors. Major factors are defined as facial pain or pressure, nasal obstruction or blockage, nasal discharge or purulence or discoloured postnasal discharge, purulence in nasal cavity, or impaired or loss of smell. Minor factors are defined as headache, fever, halitosis, fatigue, dental pain, cough, and ear pain, pressure, or fullness.
9. At randomisation, current symptoms of, or treatment for, upper respiratory tract infection, acute sinusitis, acute otitis media, or other relevant infectious process; serous otitis media is not an exclusion criterion. Participants may be re-evaluated for eligibility after symptoms resolve
10. Current smokers or a history of greater than or equal to 5 pack years
11. Previous treatment by immunotherapy with grass pollen allergen within the previous 5 years
12. History of life-threatening anaphylaxis or angioedema
13. Ongoing systemic immunosuppressive treatment
14. History of intolerance of grass pollen immunotherapy, rescue medications or their excipients
15. For females of childbearing age a positive serum or urine pregnancy test with sensitivity of less than 50 mIU/mL within 72 hours of first administration of study therapy
16. Lactating females
17. The use of any investigational drug within 30 days of the screening visit
18. Ongoing treatment with beta-blockers, calcium channel blockers, tricyclic antidepressants, monoamine oxidase inhibitors or anti-IgE monoclonal antibody
19. The presence of any medical condition that the investigator deems incompatible with participation in the trial
20. Individuals with insufficient understanding of the trial

Recruitment start date

20/09/2012

Recruitment end date

21/03/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

King's College London
London
SE1 9RT
United Kingdom

Sponsor information

Organisation

King's College London (UK)

Sponsor details

King's College London
Guy's Campus
Hodgkin Building
New Hunts House
London
SE1 1UL
United Kingdom

Sponsor type

University/education

Website

http://www.kcl.ac.uk/

Funders

Funder type

Government

Funder name

NIHR Evaluation, Trials and Studies Coordinating Centre (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

Publication citations

Additional files

Editorial Notes