NCT03990272

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

Completed Phase 3 Last updated 16 July 2020

What this trial tests

Phase 3 trial testing AIT drops in Allergic Rhinitis in 702 participants. Completed in 30 October 2017.

Timeline

20 March 2017

Primary endpoint
22 October 2017

30 October 2017

Quick facts

Lead sponsor	Beijing Tongren Hospital
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	702
Start date	20 March 2017
Primary completion	22 October 2017
Estimated completion	30 October 2017
Sites	13 locations across China

Drugs / interventions tested

• AIT drops
• placebo drops

Conditions studied

• Allergic Rhinitis — all drugs for Allergic Rhinitis →

Sponsor

Beijing Tongren Hospital

Who can join

Adults 18 to 60, any sex, with Allergic Rhinitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Chinese Guideline on Allergen Immunotherapy for Allergic Rhinitis: The 2022 Update.
   Wang C, Bao Y, Chen J, Chen X, et al · · 2022 · cited 42× · PMID 36426395 · DOI 10.4168/aair.2022.14.6.604
2. Research Advances on Health Effects of Edible <i>Artemisia</i> Species and Some Sesquiterpene Lactones Constituents.
   Trendafilova A, Moujir LM, Sousa PMC, Seca AML. · · 2020 · cited 33× · PMID 33396790 · DOI 10.3390/foods10010065
3. <i>Artemisia Annua</i> sublingual immunotherapy for seasonal allergic rhinitis: A multicenter, randomized trial.
   Lou H, Wang X, Wei Q, Zhao C, et al · · 2020 · cited 22× · PMID 32963688 · DOI 10.1016/j.waojou.2020.100458