Back to resultsSafety and Efficacy of Sublingual Immunotherapy for Allergic Rhinitis Due to Artemisia Annua
Primary Purpose
Allergic Rhinitis
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
AIT drops
placebo drops
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Rhinitis
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.
Sites / Locations
- Beijing Shijitan Hospital
- Beijing Tongren Hospital
- Peking University People's Hospital
- West China Hospital, Sichuan University
- Qingdao Municipal Hospital
- No. 202 Hospital of PLA （General Hospital of Northern Theater Command ）
- First Hospital of Shanxi Medical University
- Second Hospital of Shanxi Medical University
- Tianjin Medical University General Hospital
- Shaanxi Provincial People's Hospital
- The First Affiliated Hospital of Xi'an Jiaotong University
- General Hospital of Ningxia Medical University
- The First Affiliated Hospital of Xinjiang Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
artemisia annua allergen extract drops
Placebo drops
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
daily total nasal symptom score (dTNSS)
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)
daily Rescue Medication Scores (dRMS)
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.
Adverse events
the occurrence and severity of adverse events (AEs) and the casual relationship between AEs and the experimental drug
Full Information
NCT ID
NCT03990272
First Posted
June 12, 2019
Last Updated
July 14, 2020
Sponsor
Beijing Tongren Hospital
Collaborators
Zhejiang Wolwo Bio-Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03990272
Brief Title
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
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
March 20, 2017 (Actual)
Primary Completion Date
October 22, 2017 (Actual)
Study Completion Date
October 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tongren Hospital
Collaborators
Zhejiang Wolwo Bio-Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
702 (Actual)
8. Arms, Groups, and Interventions
Arm Title
artemisia annua allergen extract drops
Arm Type
Experimental
Arm Title
Placebo drops
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
AIT drops
Intervention Description
once a day
Intervention Type
Drug
Intervention Name(s)
placebo drops
Intervention Description
once a day
Primary Outcome Measure Information:
Title
daily combined scores of medication and rhinoconjunctivitis symptoms (CSMRS)
Description
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
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)
Secondary Outcome Measure Information:
Title
daily total nasal symptom score (dTNSS)
Description
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)
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)
Title
daily Rescue Medication Scores (dRMS)
Description
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.
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)
Title
Adverse events
Description
the occurrence and severity of adverse events (AEs) and the casual relationship between AEs and the experimental drug
Time Frame
From the first day of SLIT to Visit 9(week 32)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Beijing Shijitan Hospital
City
Beijing
Country
China
Facility Name
Beijing Tongren Hospital
City
Beijing
Country
China
Facility Name
Peking University People's Hospital
City
Beijing
Country
China
Facility Name
West China Hospital, Sichuan University
City
Chendu
Country
China
Facility Name
Qingdao Municipal Hospital
City
Qingdao
Country
China
Facility Name
No. 202 Hospital of PLA （General Hospital of Northern Theater Command ）
City
Shenyang
Country
China
Facility Name
First Hospital of Shanxi Medical University
City
Taiyuan
Country
China
Facility Name
Second Hospital of Shanxi Medical University
City
Taiyuan
Country
China
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
Country
China
Facility Name
Shaanxi Provincial People's Hospital
City
Xi'an
Country
China
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
Country
China
Facility Name
General Hospital of Ningxia Medical University
City
Yinchuan
Country
China
Facility Name
The First Affiliated Hospital of Xinjiang Medical University
City
Ürümqi
Country
China
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of Sublingual Immunotherapy for Allergic Rhinitis Due to Artemisia Annua
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