Status:
UNKNOWN
Efficacy of Artemisia Pollen Specific Allergen Immunotherapy
Lead Sponsor:
Beijing Tongren Hospital
Collaborating Sponsors:
Beijing Shijitan Hospital, Capital Medical University
Peking University People's Hospital
Conditions:
Allergic Rhinitis
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2024
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05318157
Start Date
March 31 2022
End Date
November 30 2024
Last Update
May 26 2022
Active Locations (3)
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1
Beijing Shijitan Hospital
Beijing, China
2
Beijing TongRen hospitial
Beijing, China
3
Peking University People's hospital
Beijing, China