Grass Pollen Allergen Immunotherapy Tablet (AIT) Time Course Study

• Status: Completed
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: All

Summary

About 45 million people in Europe have allergic rhinitis (hay fever) - inflammation of the nasal passages causing sneezing, runny nose, nasal congestion, itching and tearing of the eyes. In the United Kingdom (UK), seasonal hay fever due to grass pollen allergy accounts for approximately 7 times more doctors' appointments than asthma. The standard treatment for hay fever consists of treating the symptoms with a nasal spray and an antihistamine. However, in a survey taken in a UK general practice less than 40% of patients with hay fever reported good symptom control with this standard treatment. For those patients with hay fever whose symptoms are not well controlled by treatment with antihistamines and nasal sprays, subcutaneous immunotherapy (SCIT) - (monthly injections of a grass allergen extract for a period of 3-5 years) is an effective alternative, and is approved in the UK on a named patient basis. More recently, allergen immunotherapy tablets (AITs) have been developed, including grass pollen allergen tablets. These have been shown to be highly effective in the treatment of hay fever, with the additional benefit of being convenient for patients, given that they may be taken at home. Grazax® (manufactured by Allergologisk Laboratorium København (ALK)-Abello, Denmark) has UK and European Union (EU) license for use in the treatment of troublesome grass pollen induced hay fever. The aim of this research is to investigate the effects of the AIT treatment on the immune system over time - which changes are taking place and when in the course of treatment. This will provide insight into the complexities of the development of allergen-specific immune tolerance - how harmful allergic responses against innocuous substances such as grass pollen can be overridden.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Imperial College London
• Collaborators: ALK-Abelló A/S; King's College London; Wellcome Trust
• Treatments: Immunologic Factors

Criteria

Atopic Participants:

Inclusion Criteria:

• age 18 to 65

• grass pollen-induced allergic rhinoconjunctivitis for at least 2 years with peak symptoms in May-July.

• moderate to severe rhinoconjunctivitis symptoms with or without mild seasonal asthma interfering with usual daily activities/sleep.

• rhinoconjunctivitis that remains troublesome despite treatment with either antihistamines or nasal corticosteroids during the grass pollen season.

• Positive skin prick test response (wheal diameter ≥ 3 mm) to timothy grass pollen.

• Positive specific immunoglobulin E (IgE), defined as IgE immunoCAP ≥ 0.7 Immuno Solid Phase Allergenchip (ISAC) standardized units (ISU), against timothy grass pollen.

• if applicable a negative urine pregnancy test and willingness to use an effective form of contraception for the duration of involvement in the study.

• The ability to give informed consent and comply with study procedures.

• A positive grass pollen nasal allergen challenge test as defined by a total nasal symptom score (TNSS) of at least 7/12 after 5 minutes with an allergen dose of 5,000 bioequivalent units (BU)/ml.

Exclusion Criteria:

• Previous grass pollen allergen immunotherapy.

• Prebronchodilator forced expiratory volume at one second (FEV1) < 70% of predicted value out of grass-pollen season.

• A clinical history of symptomatic allergic rhinitis and/or asthma caused by an allergen to which the participant is regularly exposed.

• Perennial asthma requiring regular inhaled corticosteroids.

• Seasonal symptoms outside the grass-pollen season.

• History of emergency visit or hospital admission for asthma in the previous 12 months.

• History of chronic obstructive pulmonary disease.

• History of significant recurrent acute sinusitis.

• History of chronic sinusitis.

• At screening visit evidence for upper respiratory tract infection.Participants may be re-evaluated for eligibility after symptoms resolve.

• Current smokers or a history of ≥ 5 pack years.

• History of life-threatening anaphylaxis or angioedema.

• Ongoing systemic immunosuppressive treatment.

• The use of any investigational drug within 30 days of the screening visit.

• The presence of any medical condition that the investigator deems incompatible with participation in the study.

• History of fish allergy with positive skin test and/or positive specific IgE test to vertebrate/finned fish.

• Contraindications taking Grazax.

Non-Atopic:

Inclusion Criteria:

• age 18 to 65.

• Negative skin prick test response to timothy grass pollen and panel of aeroallergens.

• Negative specific IgE, defined as IgE immunoCAP < 0.35 ISU, against timothy grass pollen.

• If applicable a negative urine pregnancy test at the time of screening and willingness to use an effective form of contraception for the duration of involvement in the study.

• The ability to give informed consent and comply with study procedures.

Exclusion criteria:

• Previous grass pollen allergen immunotherapy.

• Prebronchodilator FEV1 < 70% of predicted value out of grass-pollen season.

• symptomatic allergic rhinitis and/or asthma caused by an allergen to which the participant is regularly and perennially exposed (e.g. cat dander).

• Perennial asthma requiring regular inhaled corticosteroids.

• Seasonal symptoms outside or during the grass-pollen season.

• History of emergency visit or hospital admission for asthma in the previous 12 months.

• History of chronic obstructive pulmonary disease.

• History of significant recurrent acute sinusitis.

• History of chronic sinusitis.

• At screening visit, current symptoms of upper respiratory tract infection. Participants may be re-evaluated for eligibility after symptoms resolve.

• Current smokers or a history of ≥ 5 pack years.

• History of life-threatening anaphylaxis or angioedema.

• Ongoing systemic immunosuppressive treatment.

• The use of any investigational drug within 30 days of the screening visit.

• The presence of any medical condition that the investigator deems incompatible with participation in the study.