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

Last updated: July 14, 2020
Sponsor: Beijing Tongren Hospital
Overall Status: Completed

Phase

3

Condition

Allergies & Asthma

Allergy (Pediatric)

Allergy

Treatment

N/A

Clinical Study ID

NCT03990272
TR-SLIT-AA-MC
  • Ages 18-60
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 giventheir written consent, willing to comply with the protocol.

  • patients who are able to understand the information given and the consent and completethe daily record card.

Exclusion

Exclusion Criteria:

  • patients with severe asthma, perennial allergic rhinitis, cancer or other seriousdiseases that are unfit to receive allergen immunotherapy

  • patients who are taking β-antagonists or have taken systemic corticosteroids in last 4weeks

  • patients whose Humulus- or Artemisiifolia-specific immunoglobulin E (IgE) levels (ImmunoCAP) same as or higher than Artemisia-specific immunoglobulin E (IgE) level.

Study Design

Total Participants: 702
Study Start date:
March 20, 2017
Estimated Completion Date:
October 30, 2017

Connect with a study center

  • Beijing Shijitan Hospital

    Beijing,
    China

    Site Not Available

  • Beijing Tongren Hospital

    Beijing,
    China

    Site Not Available

  • Peking University People's Hospital

    Beijing,
    China

    Site Not Available

  • West China Hospital, Sichuan University

    Chendu,
    China

    Site Not Available

  • Qingdao Municipal Hospital

    Qingdao,
    China

    Site Not Available

  • No. 202 Hospital of PLA （General Hospital of Northern Theater Command ）

    Shenyang,
    China

    Site Not Available

  • First Hospital of Shanxi Medical University

    Taiyuan,
    China

    Site Not Available

  • Second Hospital of Shanxi Medical University

    Taiyuan,
    China

    Site Not Available

  • Tianjin Medical University General Hospital

    Tianjin,
    China

    Site Not Available

  • Shaanxi Provincial People's Hospital

    Xi'an,
    China

    Site Not Available

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an,
    China

    Site Not Available

  • General Hospital of Ningxia Medical University

    Yinchuan,
    China

    Site Not Available

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi,
    China

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.