Vestibular Versus Sublingual Route of AIT Tablets

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the tolerability of the vestibular administration route of birch pollen, grass pollen, ragweed pollen, and house dust mite (HDM) AIT tablets compared with the sublingual route in adult subjects with allergic rhinitis/conjunctivitis (AR/C)

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clinique Spécialisée en Allergies de la Capitale
• Collaborator: ALK-Abelló A/S

Criteria

Inclusion Criteria:

• Written informed consent obtained before any trial related procedures are performed

• Male or female of any race/ethnicity aged 18-65 years at the time of signing the informed consent

• A clinically relevant history of birch pollen-, grass pollen-, ragweed pollen-, or HDM allergen-induced AR/C with or without asthma requiring treatment during the respective allergen season for birch pollen, grass pollen, or ragweed pollen, or perennial AR/C for HDM.

• Positive SPT (5 mm wheal size or greater) to birch pollen, timothy grass pollen, ragweed pollen, or Dermatophagoides pteronyssinus/farinae within the previous 12 months

• A device with daily access to the internet

Exclusion Criteria:

• • Previous SLIT-tablet treatment

• Subcutaneous AIT treatment for the sensitized allergen within less than 5 years of screening

• Severe acute or chronic oral inflammation. Subjects with acute oral inflammation may be randomised when the condition has been resolved

• A history or diagnosis of eosinophilic oesophagitis

• A relevant history of systemic allergic reaction e.g. anaphylaxis with cardiorespiratory symptoms, generalised urticaria or severe facial angioedema that in the opinion of the investigator may constitute an increased safety concern

• Unstable, severe asthma (FEV1 <70% of predicted value after adequate pharmacologic treatment) at randomisation

• Currently taking beta-blockers