Longterm effects of grass tablet sublingual immunotherapy

• Research type

  Research Study

• Full title

  A Randomised, Double-blind, Single-centre, Placebo controlled Study of Sublingual Immunotherapy and Subcutaneous Immunotherapy in Adults with Seasonal Allergic Rhinitis (ITN043AD)

• IRAS ID

  64477

• Sponsor organisation

  University of California, San Francisco, Immune Tolerance Network

• Eudract number

  2010-023536-16

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Seasonal allergic rhinitis (hay fever) affects one in four of the population of UK and is a major cause of impaired quality of life. Antihistamines and nasal steroid sprays are the mainstay of treatment although recent community surveys show that less than 40% of sufferers report good control of symptoms with these medications. Grass pollen allergen immunotherapy involves repeated administration of an allergen extract in order to induce a state of clinical and immunological tolerance. Studies have shown that 2-3 years injection (subcutaneous) immunotherapy is effective in controlling symptoms and the need for antiallergic drugs and may induce long-term disease remission for at least 3 years after its discontinuation. However these benefits must be weighed against possible risk of allergic side effects of this form of immunotherapy which has to be performed in a specialist clinic. This long-term benefit has recently been confirmed in a study of grass pollen tablet sublingual (under the tongue) immunotherapy. The sublingual route is safer and allows home administration, thereby potentially broadening the indication for this form of treatment. We propose a double - blind placebo controlled trial (n=90) in order to test whether sublingual immunotherapy does indeed induce tolerance and to explore the underlying mechanism in comparison with the standard subcutaneous route. Participants will receive subcutaneous or sublingual immunotherapy or placebo in a “double dummy” design for 2 years followed by one year of follow up. The primary outcome will be the response to a nasal provocation test with grass pollen extract. Seasonal symptoms and medication use will be recorded. Nasaflud and blood samples will be collected at baseline and annually, with at the end of year 3 a nasal biopsy (a painless procedure to remove a 2mm sample of nasal lining) for laboratory studies to understand more clearly the mechanism of immunotherapy.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  11/H0406/1

• Date of REC Opinion

  25 Feb 2011

• REC opinion

  Further Information Favourable Opinion