Safety and Efficacy of Sublingual Immunotherapy for Allergic Rhinitis Due to Artemisia Annua

Capital Medical University

Status and phase

Completed

Phase 3

Conditions

Allergic Rhinitis

Treatments

Drug: AIT drops

Drug: placebo drops

Study type

Interventional

Funder types

Other

Identifiers

NCT03990272

TR-SLIT-AA-MC

Details and patient eligibility

About

Allergic rhinitis (AR) is a common disease of nasal mucosa, affecting 10% to 40% of the population globally. Allergen specific immunotherapy (AIT) is the only etiological treatment available for AR.Traditionally, AIT is divided into subcutaneous immunotherapy (SCIT) and sublingual immunotherapy (SLIT). Artemisia annua is one of the most important allergen that is responsible for seasonal AR in China during July and October.

The trial is a randomized, double-blind, placebo-controlled, multicentred, phase III trial. 702 subjects with allergic rhinitis caused by Artemisia pollen were recruited and randomized to the immunotherapy group and placebo group.

Enrollment

702 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

presence of seasonal rhinitis symptoms for over 2 years
artemisia-specific immunoglobulin E (IgE) levels (ImmunoCAP) of class 3 or higher
patients who have been informed of the nature and aims of the study and have given their written consent, willing to comply with the protocol.
patients who are able to understand the information given and the consent and complete the daily record card.

Exclusion criteria

patients with severe asthma, perennial allergic rhinitis, cancer or other serious diseases that are unfit to receive allergen immunotherapy
patients who are taking β-antagonists or have taken systemic corticosteroids in last 4 weeks
patients whose Humulus- or Artemisiifolia-specific immunoglobulin E (IgE) levels (ImmunoCAP) same as or higher than Artemisia-specific immunoglobulin E (IgE) level.