Clinical trial NCT03990272: Safety and Efficacy of Sublingual Immunotherapy for Allergic Rhinitis Due to Artemisia Annua
Official title: Safety and Efficacy of Sublingual Immunotherapy for Allergic Rhinitis Due to Artemisia Annua: a Randomized, Double Blind,Placebo Controlled, Phase III Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergic Rhinitis
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
Collaborators: name: Zhejiang Wolwo Bio-Pharmaceutical Co., Ltd.
First posted: 2019-06-18
Enrollment: 702
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: daily combined scores of medication and rhinoconjunctivitis symptoms (CSMRS)
timeFrame: 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)
Secondary outcomes:
measure: daily total nasal symptom score (dTNSS)
timeFrame: 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)
measure: daily Rescue Medication Scores (dRMS)
timeFrame: 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)
measure: Adverse events
timeFrame: From the first day of SLIT to Visit 9(week 32)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Shijitan Hospital
city: Beijing
country: China
facility: Beijing Tongren Hospital
city: Beijing
country: China
facility: Peking University People's Hospital
city: Chendu
country: China
facility: West China Hospital, Sichuan University
city: Qingdao
country: China
facility: Qingdao Municipal Hospital
city: Shenyang
country: China
facility: No. 202 Hospital of PLA （General Hospital of Northern Theater Command ）
city: Taiyuan
country: China
facility: First Hospital of Shanxi Medical University
city: Taiyuan
country: China
facility: Second Hospital of Shanxi Medical University
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
city: Xi'an
country: China
facility: Shaanxi Provincial People's Hospital
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
city: Ürümqi
country: China
facility: The First Affiliated Hospital of Xinjiang Medical University
Study officials:
References: