Safety and Efficacy of Sublingual Immunotherapy for Allergic Rhinitis Due to Artemisia Annua
1 other identifier
interventional
702
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2017
Shorter than P25 for phase_3
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 22, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2017
CompletedFirst Submitted
Initial submission to the registry
June 12, 2019
CompletedFirst Posted
Study publicly available on registry
June 18, 2019
CompletedJuly 16, 2020
July 1, 2020
7 months
June 12, 2019
July 14, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
daily combined scores of medication and rhinoconjunctivitis symptoms (CSMRS)
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
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 (3)
daily total nasal symptom score (dTNSS)
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)
daily Rescue Medication Scores (dRMS)
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)
Adverse events
From the first day of SLIT to Visit 9(week 32)
Study Arms (2)
artemisia annua allergen extract drops
EXPERIMENTALPlacebo drops
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Beijing Shijitan Hospital
Beijing, China
Beijing Tongren Hospital
Beijing, China
Peking University People's Hospital
Beijing, China
West China Hospital, Sichuan University
Chendu, China
Qingdao Municipal Hospital
Qingdao, China
No. 202 Hospital of PLA （General Hospital of Northern Theater Command ）
Shenyang, China
First Hospital of Shanxi Medical University
Taiyuan, China
Second Hospital of Shanxi Medical University
Taiyuan, China
Tianjin Medical University General Hospital
Tianjin, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, China
Shaanxi Provincial People's Hospital
Xi'an, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
General Hospital of Ningxia Medical University
Yinchuan, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- vise president of BeijingTongren Hospital
Study Record Dates
First Submitted
June 12, 2019
First Posted
June 18, 2019
Study Start
March 20, 2017
Primary Completion
October 22, 2017
Study Completion
October 30, 2017
Last Updated
July 16, 2020
Record last verified: 2020-07