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Long-term efficacy and safety evaluation of Artemisia annua allergens sublingual immunotherapy drops in adult patients with allergic rhinitis——Multicenter, open clinical trial

Long-term efficacy and safety evaluation of Artemisia annua allergens sublingual immunotherapy drops in adult patients with allergic rhinitis——Multicenter, open clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200060121
Enrollment
Unknown
Registered
2022-05-19
Start date
2022-03-16
Completion date
Unknown
Last updated
2024-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic rhinitis in adults

Interventions

treatment group :sublingual administration

Sponsors

Beijing Tongren Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) Aged between 18 and 60 (including 18 and 60), male or female; (2) have a history of seasonal (summer and autumn) allergic rhinitis, with or without allergic conjunctivitis; (3) The average daily score of four rhinitis symptoms in the last pollen season peak reached 6 or more points; (4) The sIgE level of artemisia was =3, and the sIgE level of ragweed and humulus scandens was lower than artemisia (5) The subject can understand and sign the informed consent; (6) Subjects can comply with the protocol.

Exclusion criteria

Exclusion criteria: (1) Patients with ulcer, inflammation or trauma in the sublingual area during screening evaluation are not suitable for administration; (2) patients who undergo major surgery within four weeks prior to screening evaluation; (3) continuous use of systemic glucocorticoids within 4 weeks prior to screening evaluation; (4) Patients with any history of severe systemic allergic reaction or eosinophilic esophagitis before screening evaluation; (5) patients with perennial allergic rhinitis; (6) patients with chronic rhinitis or sinusitis or nasal polyps; (7) The subjects reviewed the last pollen season, and the onset of rhinitis could be alleviated without using symptomatic drugs; (8) Those who had been diagnosed with moderate or severe asthma or had evidence of FEV1 < 70% of the estimated value within 2 years before enrollment; (9) those who are taking ß -blockers (including systemic and local drugs) or angiotensin converting enzyme (ACE) inhibitors; (10) Those who have participated in clinical trials of other drugs within one month; (11) those receiving other pollen allergen-specific immunotherapy; (12) pregnant and lactating women; (13) Have a history of immunosuppressive diseases (such as HIV infection), malignant tumors, autoimmune diseases, tuberculosis, cardiovascular insufficiency or other serious diseases of organ systems as judged by the investigator; (14) Any other circumstances that the Investigator deems inappropriate for participation in the study.

Design outcomes

Primary

MeasureTime frame
daily average combined scores of rhinitis symptoms and medication in pollen peak period;

Secondary

MeasureTime frame
daily average total rhinitis symptom score in pollen peak period;daily average medication score in pollen peak period;

Countries

China

Contacts

Public ContactZhang Luo

Beijing Tongren Hospital

dr.luozhang@139.com+86 139 1083 0309

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026