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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

702 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-20

Study Completion Date

2017-10-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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artemisia annua allergen extract drops

Group Type EXPERIMENTAL

AIT drops

Intervention Type DRUG

once a day

Placebo drops

Group Type PLACEBO_COMPARATOR

placebo drops

Intervention Type DRUG

once a day

Interventions

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AIT drops

once a day

Intervention Type DRUG

placebo drops

once a day

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No