Allergic RhinitisPhase 4NCT05318157
Efficacy of Artemisia Pollen Specific Allergen Immunotherapy
A Phase 4 study testing AIT drops and Clarityne, Rhinocort and Emedastine Difumarate Eye Drops in people with Allergic Rhinitis, run by Beijing Tongren Hospital at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- AIT drops and Clarityne, Rhinocort and Emedastine Difumarate Eye Drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 3 sitesChina
- Study dates
- 31 Mar 2022to 30 Nov 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 14Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
Yuan Zhang contact
China3 sites, 3 recruiting
- Not yet recruiting
Beijing Shijitan Hospital
Beijing
Xueyan Wang
- Recruiting
Beijing TongRen hospitial
Beijing
Yuan Zhang
- Not yet recruiting
Peking University People's hospital
Beijing
Xing Zhimin
About this study
Official title: Long Term Efficacy of Artemisia Pollen Specific Allergen Immunotherapy in Patients With Seasonal Allergic Rhinitis
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.
- Conditions
- Allergic Rhinitis
- Being tested
- AIT drops, Clarityne, Rhinocort and Emedastine Difumarate Eye Drops
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIT dropsDrug
Once a day
Clarityne, Rhinocort and Emedastine Difumarate Eye DropsDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Sublingual Immunotherapy group | Experimental | Not described Receives: Drug: AIT drops |
| Drugs treatment group | Experimental | Not described Receives: Drug: Clarityne, Rhinocort and Emedastine Difumarate Eye Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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 (8)
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.
Measured: 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.
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.
Measured: 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.
Health economics evaluation
Record the treatment cost of patients with allergy related diseases in the period.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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).
Measured: 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.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start31 Mar 2022
- Primary completion15 Oct 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Shijitan Hospital, Capital Medical University, Peking University People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05318157
- Sponsor's protocol ID
- TR-SAR-AIT
- Status last verified
- Mar 2022
- First submitted
- 22 Mar 2022
- Last updated
- 26 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li J, Fang D, Ma T, Liu Y, Zhang X, Liu S, Wang C, Zhang L, Zhang Y. Effect of initiation treatment timing on efficacy of Artemisia Annua sublingual immunotherapy in patients with allergic rhinitis. World Allergy Organ J. 2026 Apr 8;19(4):101381. doi: 10.1016/j.waojou.2026.101381. eCollection 2026 Apr.
PubMed 42006631
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Efficacy of Artemisia Pollen Specific Allergen Immunotherapy in Patients With Seasonal Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT05318157
- Acronym / sponsor ID
- TR-SAR-AIT
- Conditions
- Allergic Rhinitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Collaborators
- Beijing Shijitan Hospital, Capital Medical University, Peking University People's Hospital
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 15 Oct 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 8 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sublingual Immunotherapy group | Experimental | Drug: AIT drops |
| Drugs treatment group | Experimental | Drug: Clarityne, Rhinocort and Emedastine Difumarate Eye Drops |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AIT dropsOnce a day | Drug | Sublingual Immunotherapy group |
| Clarityne, Rhinocort and Emedastine Difumarate Eye DropsThe 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 | Drug | Drugs treatment group |
Primary outcome
Change from baseline symptom scores
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.
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)
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.
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.
8 secondary outcomes
daily 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.
combined symptom and medication score, CSMS
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.
Health economics evaluation
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.
adverse events
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.
The change of biomarkers
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.
The change of cytokine expression
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.
nasal patency
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.
The change of IgE level
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
- Derived from this study: PubMed 42006631Li J, Fang D, Ma T, Liu Y, Zhang X, Liu S, Wang C, Zhang L, Zhang Y. Effect of initiation treatment timing on efficacy of Artemisia Annua sublingual immunotherapy in patients with allergic rhinitis. World Allergy Organ J. 2026 Apr 8;19(4):101381. doi: 10.1016/j.waojou.2026.101381. eCollection 2026 Apr.
Related trials for Allergic Rhinitis
Not yet recruitingPhase 1
Safety and Tolerability of Fluticasone Propionate 10% Nasal Insert in Participants With Chronic Allergic Rhinitis
Chronic Allergic Rhinitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
Not yet recruitingObservational study
Prevelance of Bronchial Asthma and Allergic Rhinitis Among Children With Nephrotic Syndrom at Sohag University Hospital
Allergic Diseases in Nephrotic Children, Nephrotic Syndrom
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuan Zhang contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing AIT drops and Clarityne, Rhinocort and Emedastine Difumarate Eye Drops in people with Allergic Rhinitis, run by Beijing Tongren Hospital at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chengshuo Wang (58265806, wangcs@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline symptom scores (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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05318157, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2022.