Efficacy of Artemisia Pollen Specific Allergen Immunotherapy
Long Term Efficacy of Artemisia Pollen Specific Allergen Immunotherapy in Patients With Seasonal Allergic Rhinitis
1 other identifier
interventional
150
1 country
3
Brief Summary
Allergic rhinitis (AR) is a noninfectious inflammatory disease of the nasal mucosa mediated by immunoglobulin E (IgE) after exposure to allergens. Artemisia annua is one of the most important allergen that is responsible for seasonal AR in China during July and October. Allergen specific immunotherapy (AIT) is the only etiological treatment available for AR. The trial is a randomized, Open label, multicentred trial. A total of 150 subjects with allergic rhinitis caused by Artemisia pollen were recruited and randomized to the immunotherapy group and conversation drugs group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 2022
Typical duration for phase_4
3 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
First Submitted
Initial submission to the registry
March 22, 2022
CompletedStudy Start
First participant enrolled
March 31, 2022
CompletedFirst Posted
Study publicly available on registry
April 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2024
CompletedMay 26, 2022
March 1, 2022
2.5 years
March 22, 2022
May 21, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Change from baseline symptom scores
Symptom change before and after treatment was estimated by Visual analogue scale(VAS) symptom score. The VAS symptom scores ranged from 0 (asymptomatic) to 10 (very severe). Four nasal symptoms (itching, sneezing, rhinorrhoea and nasal obstruction) and two ocular symptoms (ocular itch and watery eyes) were included.
Visit 0: at baseline; Visit 1: at the first year of the high pollen stage; Visit 2: at the second year of the high pollen stage; Visit 3: at ending of 2 years treatment; Visit 4: at the third year of the high pollen stage.
the change of rhinoconjunctivitis quality of life questionnaire (RQLQ)
RQLQ score includes 7 aspects and 28 items: nasal symptoms, eye symptoms, non nasal and eye symptoms, behavior problems, sleep, daily activities and emotional reactions. It adopts a 0-6 point design. Among the emotional reactions, 0 point: none at any time; 1 point, not at any time; 2 points, occasionally; 3 points, sometimes; 4 points, often; 5 points, most of the time; 6 points, all the time; In other items: 0 point, not troubled; 1 point, hardly disturbed; 2 points, occasionally troubled; 3 points, moderate distress; 4 points, quite troubled; 5 points, very troubled; 6 points, extremely troubled.
Visit 0: at baseline; Visit 1: at the first year of the high pollen stage; Visit 2: at the second year of the high pollen stage; Visit 3: at ending of 2 years treatment; Visit 4: at the third year of the high pollen stage.
Secondary Outcomes (8)
daily medication score
Visit 0: at baseline; Visit 1: at the first year of the high pollen stage; Visit 2: at the second year of the high pollen stage; Visit 3: at ending of 2 years treatment; Visit 4: at the third year of the high pollen stage.
combined symptom and medication score, CSMS
Visit 0: at baseline; Visit 1: at the first year of the high pollen stage; Visit 2: at the second year of the high pollen stage; Visit 3: at ending of 2 years treatment; Visit 4: at the third year of the high pollen stage.
Health economics evaluation
Visit 0: at baseline; Visit 1: at the first year of the high pollen stage; Visit 2: at the second year of the high pollen stage; Visit 3: at ending of 2 years treatment; Visit 4: at the third year of the high pollen stage.
adverse events
Visit 0: at baseline; Visit 1: at the first year of the high pollen stage; Visit 2: at the second year of the high pollen stage; Visit 3: at ending of 2 years treatment; Visit 4: at the third year of the high pollen stage.
The change of biomarkers
Visit 0: at baseline; Visit 1: at the first year of the high pollen stage; Visit 2: at the second year of the high pollen stage; Visit 3: at ending of 2 years treatment; Visit 4: at the third year of the high pollen stage.
- +3 more secondary outcomes
Study Arms (2)
Sublingual Immunotherapy group
EXPERIMENTALDrugs treatment group
EXPERIMENTALInterventions
The following drugs were permitted as allergy symptoms-relieving medications according to the actual needs in groups: Clarityne, Rhinocort and Emedastine Difumarate Eye Drops, Once a day
Eligibility Criteria
You may qualify if:
- presence of seasonal rhinitis symptoms.
- the TNSS was higher than 6 scores in last autumn pollen season.
- artemisia-specific immunoglobulin E (IgE) levels (ImmunoCAP) at least class 3, and higher than both of ragweed and Humulus IgE levels.
- 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:
- ulcers, inflammation or trauma in the sublingual part;
- oral diseases / oral allergies;
- had surgery within four weeks before screening evaluation;
- Continuous use of systemic glucocorticoids within four weeks before screening evaluation;
- Any history of severe systemic allergic reaction and eosinophilic esophagitis before screening evaluation;
- Suffering from perennial allergic rhinitis;
- Complicated with chronic rhinitis or sinusitis, nasal polyps;
- In the recent pollen season, rhinitis can be relieved without symptomatic treatment;
- Within 2 years before enrollment, diagnosed with a history of moderate and severe asthma or FEV1 less than 70% of the estimated value;
- Applying β Treatment with receptor blockers (including systemic and local drugs) or angiotensin converting enzyme (ACE) inhibitors;
- Participated in clinical trials of other drugs within one month; Receiving other pollen allergen specific immunotherapy;
- Pregnant and lactating women or those who have pregnancy planning within the past year;
- history of immunosuppressive disease (such as HIV infection history), history of malignancy, history of autoimmune diseases, history of pulmonary tuberculosis, cardiovascular dysfunction, or other serious diseases of other organ systems judged by researchers.
- received pollen allergen specific immunotherapy or are receiving allergen specific immunotherapy within three years.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beijing Tongren Hospitallead
- Beijing Shijitan Hospital, Capital Medical Universitycollaborator
- Peking University People's Hospitalcollaborator
Study Sites (3)
Beijing Shijitan Hospital
Beijing, China
Beijing TongRen hospitial
Beijing, China
Peking University People's hospital
Beijing, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Yuan Zhang
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2022
First Posted
April 8, 2022
Study Start
March 31, 2022
Primary Completion
October 15, 2024
Study Completion
November 30, 2024
Last Updated
May 26, 2022
Record last verified: 2022-03