Last updated: May 21, 2022
Sponsor: Beijing Tongren Hospital
Overall Status: Active - Recruiting
Phase
4
Condition
Common Cold
Allergy
Acute Rhinitis
Treatment
N/AClinical Study ID
NCT05318157
TR-SAR-AIT
Ages 18-60 All Genders
Study Summary
Eligibility Criteria
Inclusion
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, andhigher than both of ragweed and Humulus IgE levels.
- patients who have been informed of the nature and aims of the study and have giventheir written consent, willing to comply with the protocol.
- patients who are able to understand the information given and the consent and completethe daily record card.
Exclusion
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 screeningevaluation;
- Any history of severe systemic allergic reaction and eosinophilic esophagitis beforescreening 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 severeasthma or FEV1 less than 70% of the estimated value;
- Applying β Treatment with receptor blockers (including systemic and local drugs) orangiotensin converting enzyme (ACE) inhibitors;
- Participated in clinical trials of other drugs within one month; Receiving otherpollen allergen specific immunotherapy;
- Pregnant and lactating women or those who have pregnancy planning within the pastyear;
- history of immunosuppressive disease (such as HIV infection history), history ofmalignancy, history of autoimmune diseases, history of pulmonary tuberculosis,cardiovascular dysfunction, or other serious diseases of other organ systems judged byresearchers.
- received pollen allergen specific immunotherapy or are receiving allergen specificimmunotherapy within three years.
Study Design
Total Participants: 150
Study Start date:
March 31, 2022
Estimated Completion Date:
November 30, 2024
Connect with a study center
Beijing Shijitan Hospital
Beijing,
ChinaSite Not Available
Beijing TongRen hospitial
Beijing,
ChinaActive - Recruiting
Peking University People's hospital
Beijing,
ChinaSite Not Available
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