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

Allergic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03990272
• Other study ID #: TR-SLIT-AA-MC
• Status: Completed
• Phase: Phase 3
• Start date: March 20, 2017
• Est. completion date: October 30, 2017

Study information

• Verified date: July 2020
• Source: Beijing Tongren Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 702
• Est. completion date: October 30, 2017
• Est. primary completion date: October 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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 ß-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.

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

Intervention

Drug:
• AIT drops
once a day
• placebo drops
once a day

Locations

Country	Name	City	State
China	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

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Tongren Hospital	Zhejiang Wolwo Bio-Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	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	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.	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	Adverse events	the occurrence and severity of adverse events (AEs) and the casual relationship between AEs and the experimental drug	From the first day of SLIT to Visit 9(week 32)