Efficacy of Artemisia Pollen Specific Allergen Immunotherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-31

Study Completion Date

2024-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sublingual Immunotherapy group

Group Type EXPERIMENTAL

AIT drops

Intervention Type DRUG

Once a day

Drugs treatment group

Group Type EXPERIMENTAL

Clarityne, Rhinocort and Emedastine Difumarate Eye Drops

Intervention Type DRUG

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

Interventions

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AIT drops

Once a day

Intervention Type DRUG

Clarityne, Rhinocort and Emedastine Difumarate Eye Drops

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No