Efficacy of Artemisia Pollen Specific Allergen Immunotherapy

Last updated: May 21, 2022
Sponsor: Beijing Tongren Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Common Cold

Allergy

Acute Rhinitis

Treatment

N/A

Clinical Study ID

NCT05318157
TR-SAR-AIT
  • Ages 18-60
  • All Genders

Study Summary

Allergic rhinitis (AR) is a noninfectious inflammatory disease of the nasal mucosa mediated by immunoglobulin E (IgE) after exposure to allergens. Artemisia annua is one of the most important allergen that is responsible for seasonal AR in China during July and October. Allergen specific immunotherapy (AIT) is the only etiological treatment available for AR.

The trial is a randomized, Open label, multicentred trial. A total of 150 subjects with allergic rhinitis caused by Artemisia pollen were recruited and randomized to the immunotherapy group and conversation drugs group.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • presence of seasonal rhinitis symptoms.
  • the TNSS was higher than 6 scores in last autumn pollen season.
  • artemisia-specific immunoglobulin E (IgE) levels (ImmunoCAP) at least class 3, andhigher than both of ragweed and Humulus IgE levels.
  • 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:

  • ulcers, inflammation or trauma in the sublingual part;
  • oral diseases / oral allergies;
  • had surgery within four weeks before screening evaluation;
  • Continuous use of systemic glucocorticoids within four weeks before screeningevaluation;
  • Any history of severe systemic allergic reaction and eosinophilic esophagitis beforescreening evaluation;
  • Suffering from perennial allergic rhinitis;
  • Complicated with chronic rhinitis or sinusitis, nasal polyps;
  • In the recent pollen season, rhinitis can be relieved without symptomatic treatment;
  • Within 2 years before enrollment, diagnosed with a history of moderate and severeasthma or FEV1 less than 70% of the estimated value;
  • Applying β Treatment with receptor blockers (including systemic and local drugs) orangiotensin converting enzyme (ACE) inhibitors;
  • Participated in clinical trials of other drugs within one month; Receiving otherpollen allergen specific immunotherapy;
  • Pregnant and lactating women or those who have pregnancy planning within the pastyear;
  • history of immunosuppressive disease (such as HIV infection history), history ofmalignancy, history of autoimmune diseases, history of pulmonary tuberculosis,cardiovascular dysfunction, or other serious diseases of other organ systems judged byresearchers.
  • received pollen allergen specific immunotherapy or are receiving allergen specificimmunotherapy within three years.

Study Design

Total Participants: 150
Study Start date:
March 31, 2022
Estimated Completion Date:
November 30, 2024

Connect with a study center

  • Beijing Shijitan Hospital

    Beijing,
    China

    Site Not Available

  • Beijing TongRen hospitial

    Beijing,
    China

    Active - Recruiting

  • Peking University People's hospital

    Beijing,
    China

    Site Not Available

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