Back to resultsEfficacy of Artemisia Pollen Specific Allergen Immunotherapy
Primary Purpose
Allergic Rhinitis
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
AIT drops
Clarityne, Rhinocort and Emedastine Difumarate Eye Drops
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Rhinitis
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.
Sites / Locations
- Beijing Shijitan Hospital
- Beijing TongRen hospitialRecruiting
- Peking University People's hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Sublingual Immunotherapy group
Drugs treatment group
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
daily medication score
medication score in each day during the peak pollen season (ranging from 0 to 3). 0 = no rescue medication uses, 1 = Oral and/or topical non-sedative H1 antihistamines, 2 = Intranasal corticosteroids (Rhinocort) with/without H1 antihistamines, and 3 = Oral corticosteroids with/without intranasal corticosteroids, with/without H1 antihistamines.
combined symptom and medication score, CSMS
the daily combined scores of medication and rhinoconjunctivitis symptoms (CSMRS) (ranging from 0 to 6); which was calculated as the combined score of daily average scores of 6 rhinoconjunctivitis symptoms (rhinorrhea, nasal congestion, nasal itching, sneezing, ocular pruritus, and watery eyes) and the daily rescue medication score.
Health economics evaluation
Record the treatment cost of patients with allergy related diseases in the period.
adverse events
Any adverse event following acupuncture was assessed by physicians and patients. Patients were instructed to record any unexpected signs, symptoms, and feelings during the entire trial period.
The change of biomarkers
The levels of neuropeptides; including substance P, vasoactive intestinal peptide (VIP) , neuropeptide Y (NPY)) will be analysed using ELISA. The unit of all these parameters is ng/ml.
The change of cytokine expression
Quantitative real-time reverse transcription PCR (qRT-PCR) was used to analyze the mRNA expression levels of the cytokines interleukin-4, interleukin-5, interleukin-13, leukotriene C4, RANTES, tumor necrosis factor-α, thymic stromal lymphopoietin, and EOTAXIN in the nasal mucosa before and after treatment. The qRT-PCR data were processed using the 2-△△CT method.
nasal patency
Eccovision acoustic rhinometry was used to measure the nasal cavity volume (NCV) according to standardized recommendations. Measurements of nasal volume were made from the first 2 cm (V2), the first 4 cm (V4), from the first 6 cm (V6), from the segment between 0 and 5 cm (V0-5), and the segment between 0 and 7 cm (V0-7) of the nose. All measurements were performed three times by the same operator, and nasal volumes were calculated as the sum of both nostrils24. In the current study, the change in the nasal cavity volume was measured at 2-5 cm, as this seems to be an important variable for mucosal changes.24 Nasal airway resistance (NAR) was measured by anterior active rhinomanometry in a quiet room at temperature of 25°C and humidity of 70%. NAR was measured at 75 Pa point (R75T).
The change of IgE level
The levels of sIgE and sIgG will be analysed using Unicap250. The unit of all these parameters is kU/ml.
Full Information
NCT ID
NCT05318157
First Posted
March 22, 2022
Last Updated
May 21, 2022
Sponsor
Beijing Tongren Hospital
Collaborators
Beijing Shijitan Hospital, Capital Medical University, Peking University People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05318157
Brief Title
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
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 31, 2022 (Actual)
Primary Completion Date
October 15, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Tongren Hospital
Collaborators
Beijing Shijitan Hospital, Capital Medical University, Peking University People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sublingual Immunotherapy group
Arm Type
Experimental
Arm Title
Drugs treatment group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
AIT drops
Intervention Description
Once a day
Intervention Type
Drug
Intervention Name(s)
Clarityne, Rhinocort and Emedastine Difumarate Eye Drops
Intervention Description
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
Primary Outcome Measure Information:
Title
Change from baseline symptom scores
Description
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.
Time Frame
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.
Title
the change of rhinoconjunctivitis quality of life questionnaire (RQLQ)
Description
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.
Time Frame
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 Outcome Measure Information:
Title
daily medication score
Description
medication score in each day during the peak pollen season (ranging from 0 to 3). 0 = no rescue medication uses, 1 = Oral and/or topical non-sedative H1 antihistamines, 2 = Intranasal corticosteroids (Rhinocort) with/without H1 antihistamines, and 3 = Oral corticosteroids with/without intranasal corticosteroids, with/without H1 antihistamines.
Time Frame
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.
Title
combined symptom and medication score, CSMS
Description
the daily combined scores of medication and rhinoconjunctivitis symptoms (CSMRS) (ranging from 0 to 6); which was calculated as the combined score of daily average scores of 6 rhinoconjunctivitis symptoms (rhinorrhea, nasal congestion, nasal itching, sneezing, ocular pruritus, and watery eyes) and the daily rescue medication score.
Time Frame
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.
Title
Health economics evaluation
Description
Record the treatment cost of patients with allergy related diseases in the period.
Time Frame
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.
Title
adverse events
Description
Any adverse event following acupuncture was assessed by physicians and patients. Patients were instructed to record any unexpected signs, symptoms, and feelings during the entire trial period.
Time Frame
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.
Title
The change of biomarkers
Description
The levels of neuropeptides; including substance P, vasoactive intestinal peptide (VIP) , neuropeptide Y (NPY)) will be analysed using ELISA. The unit of all these parameters is ng/ml.
Time Frame
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.
Title
The change of cytokine expression
Description
Quantitative real-time reverse transcription PCR (qRT-PCR) was used to analyze the mRNA expression levels of the cytokines interleukin-4, interleukin-5, interleukin-13, leukotriene C4, RANTES, tumor necrosis factor-α, thymic stromal lymphopoietin, and EOTAXIN in the nasal mucosa before and after treatment. The qRT-PCR data were processed using the 2-△△CT method.
Time Frame
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.
Title
nasal patency
Description
Eccovision acoustic rhinometry was used to measure the nasal cavity volume (NCV) according to standardized recommendations. Measurements of nasal volume were made from the first 2 cm (V2), the first 4 cm (V4), from the first 6 cm (V6), from the segment between 0 and 5 cm (V0-5), and the segment between 0 and 7 cm (V0-7) of the nose. All measurements were performed three times by the same operator, and nasal volumes were calculated as the sum of both nostrils24. In the current study, the change in the nasal cavity volume was measured at 2-5 cm, as this seems to be an important variable for mucosal changes.24 Nasal airway resistance (NAR) was measured by anterior active rhinomanometry in a quiet room at temperature of 25°C and humidity of 70%. NAR was measured at 75 Pa point (R75T).
Time Frame
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.
Title
The change of IgE level
Description
The levels of sIgE and sIgG will be analysed using Unicap250. The unit of all these parameters is kU/ml.
Time Frame
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chengshuo Wang
Phone
58265806
Email
wangcs@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yuan Zhang
Facility Information:
Facility Name
Beijing Shijitan Hospital
City
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xueyan Wang
Facility Name
Beijing TongRen hospitial
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuan Zhang
Facility Name
Peking University People's hospital
City
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xing Zhimin
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Artemisia Pollen Specific Allergen Immunotherapy
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