Clinical trial NCT05318157: Efficacy of Artemisia Pollen Specific Allergen Immunotherapy
Official title: Long Term Efficacy of Artemisia Pollen Specific Allergen Immunotherapy in Patients With Seasonal Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Allergic Rhinitis
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Shijitan Hospital, Capital Medical University
name: Peking University People's Hospital
First posted: 2022-04-08
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change from baseline symptom scores
timeFrame: 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.
measure: the change of rhinoconjunctivitis quality of life questionnaire (RQLQ)
timeFrame: 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:
measure: daily medication score
timeFrame: 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.
measure: combined symptom and medication score, CSMS
timeFrame: 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.
measure: Health economics evaluation
timeFrame: 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.
measure: adverse events
timeFrame: 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.
measure: The change of biomarkers
timeFrame: 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.
measure: The change of cytokine expression
timeFrame: 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.
measure: nasal patency
timeFrame: 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.
measure: The change of IgE level
timeFrame: 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.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Shijitan Hospital
city: Beijing
country: China
facility: Beijing TongRen hospitial
city: Beijing
country: China
facility: Peking University People's hospital
Study officials:
References: