Sublingual immunotherapy (SLIT) with grass pollen allergen for grasspollen induced rhinoconjunctivitis in children.

Background:

Grass pollen induced rhinoconjunctivitis is common in children. Hayfever interferes with daily activities of these children and their wellbeing is severely affected.

Treatment of allergic rhinoconjunctivitis in children is symptomatic. Immunotherapy is seldom indicated in children because of possible severe, adverse events and a parental way of administration. Sublingual immunotherapy (SLIT) offers an alternative.

Study design:

Children aged 6 to 18 years known in general practice with a documented clinical history of grass pollen allergy with moderate disease intensity and a positive grass pollen specific IgE Rast test, were included in a triple blinded placebo controlled, randomised trial.

- Inclusion criteria were a total symptom score ¡Ý 5; a positive grass pollen specific IgE Rast test ¡Ý 2+; and informed consent.
- Main exclusion criteria were; inhalant therapy with daily steroids during ¡Ý 3 months a year and allergic sensitivity to epithelial in case the domestic animal is present in the family home.

Outcome measures:

Efficacy is measured by patient-assessed symptom scores. The intensity of 5 allergic symptoms: sneezing; itching nose; watery running nose; nasal blockage; itching eyes. was subjectively assessed according to a grading scale: 0 = no complaints; 1 = minor complaints; 2 = moderate complaints; 3 = serious complaints; i. e. the maximal score amounts to a value of 15.
- The periods of measurement were May till August in the years 2002 and 2003; 2003 and 2004. During these periods symptom scores were assessed daily by the patient and recorded in a patient diary.
- Main Secondary outcome measures were number of medication free days, rescue medication used, rhinitis specific quality of life, adverse effects and compliance.

Aim of the study:

To evaluate the efficacy of SLIT in comparison with placebo, on the symptoms of allergic rhinoconjunctivitis in 6 to 18 years old children known to their GP with a rhinoconjunctivitis due to grass pollen allergy.

In comparison with placebo SLIT will lead to a clinical relevant symptom reduction in 6 to 18 years old children with a rhinoconjunctivitis due to grass pollen allergy.

N/A

Active treatment:

Oralgen ® Grass Pollen (9.500 BU/ml), consists of a mixture of aqueous extracts of the pollen of five grass pollen species in a glycerinated isotonic phosphate buffered solution.

The following grass pollen species are included:

¡¤Phleum pratense: Timothy, (Timotheegras)

¡¤Dactylis glomerate: Orchard grass, (Kropaar)

¡¤Anthoxantum odoratum: Vernal grass, Sweet grass, (Reukgras)

¡¤Holcus lanatus: Velvet grass, (Echte witbol)

¡¤Lolium perenne: Ryegrass, Perennial grass, (Engels raaigras)

Other ingredients include sodium chloride, sodium dihydrogen phosphate, disodium hydrogen phosphate, glycerol and water.


Control treatment:

The placebo consists of the non-active excipients, as mentioned above. Placebo treatment group.

The placebo consists of the non?active excipients, as mentioned above. Placebo treatment will be delivered in such a way that neither patients nor investigators or other research personnel can make a distinction between verum and placebo vials.


Dose schedule:

The treatment is divided in two phases: a dose escalation phase of 20 days, and a maintenance phase of 2 years. Treatment starts on day 1 with a single drop (one drop 0,05 ml = 475 BU); the dose is increased with one drop per day until day 20 (20 drops = l ml = 9.500 BU). The maintenance dose is 20 drops (=9500 BU) twice weekly.