Seasonal Allergic RhinitisPhase 3NCT03649139
Effect and Underlying Immunological Mechanisms of Sublingual Immunotherapy in Allergic Rhinitis
A Phase 3 study testing sublingual immunotherapy drops in people with Seasonal Allergic Rhinitis, run by Beijing Tongren Hospital at 1 site in China.
Trial summary
Allergic rhinitis (AR) is a common Ig-E mediated disease of nasal mucosa, induced by an immunoglobulin E (IgE)-mediated reaction in the allergen-sensitized subjects, affecting 10% to 40% of the world population. AR could be divided into two kinds, perennial AR and seasonal AR (SAR). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- sublingual immunotherapy drops
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2017to 30 Oct 2018
- Phase
- Phase 3
- 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
- Male or female outpatients aged 18 to 60 years (inclusive).
- With history of SAR for at least two years, with/without conjunctivitis and asthma
- Two or more nasal symptoms scores were ≥ 2 points during July - October in the last year.
- Sensitised to artemisia annua (specific IgE level ≥ 3.5 kilounit per liter).
- 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
- Patients whose Humulus- or Artemisiifolia-specific immunoglobulin E (IgE) levels (ImmunoCAP) same as or higher than Artemisia-specific immunoglobulin E (IgE) level.
- Patients with oral diseases/ allergies within the run-in period.
- Patients accepted any kind of operations within 4 weeks of the run-in period.
- Patients applied for systemic glucocorticoids within 4 weeks in the run-in period.
- Patients with perennial AR.
- Patients with any nasal condition that could confound the results of the study (chronic rhinitis, chronic rhinosinusitis with/without polyps).
- Whatever the co-sensitization leading to clinically relevant AR, conjunctivitis or asthma likely to significantly change the symptoms of the patient throughout the study.
- Patients with comorbidity of severe asthma.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect and Underlying Immunological Mechanisms of Sublingual Immunotherapy in Seasonal Allergic Rhinitis: a Randomized, Double Blind, Placebo Controlled Trial
Allergic rhinitis (AR) is a common Ig-E mediated disease of nasal mucosa, induced by an immunoglobulin E (IgE)-mediated reaction in the allergen-sensitized subjects, affecting 10% to 40% of the world population. AR could be divided into two kinds, perennial AR and seasonal AR (SAR). Allergen specific immunotherapy (AIT) is the only etiological treatment available for AR. Traditionally, AIT is divided into 2 types, subcutaneous immunotherapy (SCIT) and sublingual immunotherapy (SLIT), both of which are effective and safe alternatives.
The trial is a randomized, double-blind, placebo-controlled trial. 72 eligible SAR patients, who were sensitized to sweet sagewort (artemisia annua), were enrolled into the trial, followed by either a 32-week SLIT schedule, where the maintenance dose would be reached within 5 weeks, or placebo SLIT schedule. Standardized depot preparations of sweet sagewort (artemisia annua) extract (Zhejiang Wolwo Bio-pharmaceutical Co., Ltd., China ) were administered by means of sublingual drops.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- sublingual immunotherapy drops, Placebo drops
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sublingual immunotherapy dropsDrug
artemisia annua (sweet sagewort) allergen extract drops
Placebo dropsDrug
sublingual placebo drops
| Study group | Role | What they receive |
|---|---|---|
| artemisia annua (sweet sagewort) allergen extract drops | Active comparator | Drug: sublingual immunotherapy drops Receives: Drug: sublingual immunotherapy drops |
| Placebo drops | Placebo comparator | Drug: sublingual placebo drops Receives: Drug: Placebo drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline symptom scores at Week 16
Primary outcome is the assessment data from all patients whom will record on diary cards their symptom scores based on visual analog scales, ranging from 0(asymptomatic) to 3(most severe).
Measured: at baseline, Week 16
Secondary outcomes (5)
Quality of life
Assessment data from all patients whom will record on diary cards their quality-of-life measures for rhinitis(rhinoconjunctivitis quality of life questionnaire,RQLQ), including 28 questions, ranging from 0 (do not affect quality of life) to 6 (severely affect quality of life).
Measured: at the pollen season of 2016, baseline, Week 16, Week 32, 6 months after discontinuation of treatment
Medication scores
Assessment data from all patients whom will record on diary cards their medication usage.
Measured: at the pollen season of 2016, baseline, Week 16, Week 32, 6 months after discontinuation of treatment
Immunologic Changes-IgE
Changes in total serum IgE, specific IgE levels in peripheral blood.
Measured: at baseline, Week 16, Week 32
Immunologic Changes-M2 population
Changes in M2 population in peripheral blood and nasal secretion (Flow cytometry).
Measured: at baseline, Week 16, Week 32
Change of symptom scores
Assessment data from all patients whom will record on diary cards their symptom scores based on visual analog scales.
Measured: at the pollen season of 2016, Week 16 and 6 months after discontinuation of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study start1 Apr 2017
- Primary completion30 Oct 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- experiment:placebo=2:1
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang Wolwo Bio-Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Luo Zhang, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03649139
- Sponsor's protocol ID
- TR-SLIT-IMMUNO
- Status last verified
- Jun 2019
- First submitted
- 2 Aug 2018
- Last updated
- 11 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect and Underlying Immunological Mechanisms of Sublingual Immunotherapy in Seasonal Allergic Rhinitis: a Randomized, Double Blind, Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT03649139
- Acronym / sponsor ID
- TR-SLIT-IMMUNO
- Conditions
- Seasonal Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Collaborators
- Zhejiang Wolwo Bio-Pharmaceutical Co., Ltd.
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 28 Aug 2018 (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 common Ig-E mediated disease of nasal mucosa, induced by an immunoglobulin E (IgE)-mediated reaction in the allergen-sensitized subjects, affecting 10% to 40% of the world population. AR could be divided into two kinds, perennial AR and seasonal AR (SAR). Allergen specific immunotherapy (AIT) is the only etiological treatment available for AR. Traditionally, AIT is divided into 2 types, subcutaneous immunotherapy (SCIT) and sublingual immunotherapy (SLIT), both of which are effective and safe alternatives.
The trial is a randomized, double-blind, placebo-controlled trial. 72 eligible SAR patients, who were sensitized to sweet sagewort (artemisia annua), were enrolled into the trial, followed by either a 32-week SLIT schedule, where the maintenance dose would be reached within 5 weeks, or placebo SLIT schedule. Standardized depot preparations of sweet sagewort (artemisia annua) extract (Zhejiang Wolwo Bio-pharmaceutical Co., Ltd., China ) were administered by means of sublingual drops.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- experiment:placebo=2:1
| Arm | Type | Receives |
|---|---|---|
| artemisia annua (sweet sagewort) allergen extract drops | Active comparator | Drug: sublingual immunotherapy dropsDrug: sublingual immunotherapy drops |
| Placebo drops | Placebo comparator | Drug: Placebo dropsDrug: sublingual placebo drops |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or female outpatients aged 18 to 60 years (inclusive).
- With history of SAR for at least two years, with/without conjunctivitis and asthma
- Two or more nasal symptoms scores were ≥ 2 points during July - October in the last year.
- Sensitised to artemisia annua (specific IgE level ≥ 3.5 kilounit per liter).
- 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.
Key exclusion criteria (8 listed)
- Patients whose Humulus- or Artemisiifolia-specific immunoglobulin E (IgE) levels (ImmunoCAP) same as or higher than Artemisia-specific immunoglobulin E (IgE) level.
- Patients with oral diseases/ allergies within the run-in period.
- Patients accepted any kind of operations within 4 weeks of the run-in period.
- Patients applied for systemic glucocorticoids within 4 weeks in the run-in period.
- Patients with perennial AR.
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 |
|---|---|---|
| sublingual immunotherapy dropsartemisia annua (sweet sagewort) allergen extract drops | Drug | artemisia annua (sweet sagewort) allergen extract drops |
| Placebo dropssublingual placebo drops | Drug | Placebo drops |
Primary outcome
change from baseline symptom scores at Week 16
Time frame: at baseline, Week 16
Primary outcome is the assessment data from all patients whom will record on diary cards their symptom scores based on visual analog scales, ranging from 0(asymptomatic) to 3(most severe).
5 secondary outcomes
Quality of life
Time frame: at the pollen season of 2016, baseline, Week 16, Week 32, 6 months after discontinuation of treatment
Medication scores
Time frame: at the pollen season of 2016, baseline, Week 16, Week 32, 6 months after discontinuation of treatment
Immunologic Changes-IgE
Time frame: at baseline, Week 16, Week 32
Immunologic Changes-M2 population
Time frame: at baseline, Week 16, Week 32
Change of symptom scores
Time frame: at the pollen season of 2016, Week 16 and 6 months after discontinuation of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing sublingual immunotherapy drops in people with Seasonal Allergic Rhinitis, run by Beijing Tongren Hospital at 1 site 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 6 inclusion and 8 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: finished, as of the sponsor's last update on 11 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline symptom scores at Week 16 (time frame: at baseline, Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jun 2019.