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NCT Number: NCT03990272

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

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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Key information

Conditions

Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing Shijitan Hospital, Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AIT drops

Drug

once a day

Placebo drops

Drug

once a day

Primary outcomes

  1. daily combined scores of medication and rhinoconjunctivitis symptoms (CSMRS)

    Time frame: at the peak pollen season(The start was defined as the first of 3 consecutive days with a pollen count of 50 pollen/m3 or greater each day. The end was defined as the last occurrence of 3 consecutive days with ≥50 pollen/m3 each day)

    the daily combined scores of medication and rhinoconjunctivitis symptoms (CSMRS) (ranging from 0 to 6); which was calculated as the combined score of daily average scores of 6 rhinoconjunctivitis symptoms (rhinorrhea, nasal congestion, nasal itching, sneezing, ocular pruritus, and watery eyes) and the daily rescue medication score

Secondary outcomes

  1. daily total nasal symptom score (dTNSS)

    Time frame: at the peak pollen season(The start was defined as the first of 3 consecutive days with a pollen count of 50 pollen/m3 or greater each day. The end was defined as the last occurrence of 3 consecutive days with ≥50 pollen/m3 each day)

    dTNSS was the sum of four nasal symptom scores for nasal congestion, discharge, itching and sneezing (ranging from 0 to 12). Nasal symptoms during the pollen season were rated on a 4-point scale, while 0 = no symptoms, 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), and 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping)

  2. daily Rescue Medication Scores (dRMS)

    Time frame: at the peak pollen season(The start was defined as the first of 3 consecutive days with a pollen count of 50 pollen/m3 or greater each day. The end was defined as the last occurrence of 3 consecutive days with ≥50 pollen/m3 each day)

    dRMS is the rescue medication score in each day during the peak pollen season (ranging from 0 to 3). 0 = no rescue medication uses, 1 = Oral and/or topical non-sedative H1 antihistamines, 2 = Intranasal corticosteroids (Rhinocort) with/without H1 antihistamines, and 3 = Oral corticosteroids with/without intranasal corticosteroids, with/without H1 antihistamines.

  3. Adverse events

    Time frame: From the first day of SLIT to Visit 9(week 32)

    the occurrence and severity of adverse events (AEs) and the casual relationship between AEs and the experimental drug

Sponsors and collaborators

Lead sponsor

Beijing Tongren Hospital

Other

Collaborators

  • Zhejiang Wolwo Bio-Pharmaceutical Co., Ltd.

Registry information

Official study title

Safety and Efficacy of Sublingual Immunotherapy for Allergic Rhinitis Due to Artemisia Annua: a Randomized, Double Blind,Placebo Controlled, Phase III Trial

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 18, 2019
Registry last updated
Jul 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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