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Effect and Underlying Immunological Mechanisms of Sublingual Immunotherapy in Allergic Rhinitis

Primary Purpose

Seasonal Allergic Rhinitis

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
sublingual immunotherapy drops
Placebo drops
Sponsored by
Beijing Tongren Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seasonal Allergic Rhinitis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Beijing Tongren Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

artemisia annua (sweet sagewort) allergen extract drops

Placebo drops

Arm Description

Drug: sublingual immunotherapy drops

Drug: sublingual placebo drops

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
Medication scores
Assessment data from all patients whom will record on diary cards their medication usage.
Immunologic Changes-IgE
Changes in total serum IgE, specific IgE levels in peripheral blood.
Immunologic Changes-M2 population
Changes in M2 population in peripheral blood and nasal secretion (Flow cytometry).
Change of symptom scores
Assessment data from all patients whom will record on diary cards their symptom scores based on visual analog scales.

Full Information

First Posted
August 2, 2018
Last Updated
June 7, 2019
Sponsor
Beijing Tongren Hospital
Collaborators
Zhejiang Wolwo Bio-Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03649139
Brief Title
Effect and Underlying Immunological Mechanisms of Sublingual Immunotherapy in Allergic Rhinitis
Official Title
Effect and Underlying Immunological Mechanisms of Sublingual Immunotherapy in Seasonal Allergic Rhinitis: a Randomized, Double Blind, Placebo Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
October 30, 2018 (Actual)
Study Completion Date
October 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tongren Hospital
Collaborators
Zhejiang Wolwo Bio-Pharmaceutical Co., Ltd.

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Rhinitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
experiment:placebo=2:1
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
artemisia annua (sweet sagewort) allergen extract drops
Arm Type
Active Comparator
Arm Description
Drug: sublingual immunotherapy drops
Arm Title
Placebo drops
Arm Type
Placebo Comparator
Arm Description
Drug: sublingual placebo drops
Intervention Type
Drug
Intervention Name(s)
sublingual immunotherapy drops
Intervention Description
artemisia annua (sweet sagewort) allergen extract drops
Intervention Type
Drug
Intervention Name(s)
Placebo drops
Intervention Description
sublingual placebo drops
Primary Outcome Measure Information:
Title
change from baseline symptom scores at Week 16
Description
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).
Time Frame
at baseline, Week 16
Secondary Outcome Measure Information:
Title
Quality of life
Description
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).
Time Frame
at the pollen season of 2016, baseline, Week 16, Week 32, 6 months after discontinuation of treatment
Title
Medication scores
Description
Assessment data from all patients whom will record on diary cards their medication usage.
Time Frame
at the pollen season of 2016, baseline, Week 16, Week 32, 6 months after discontinuation of treatment
Title
Immunologic Changes-IgE
Description
Changes in total serum IgE, specific IgE levels in peripheral blood.
Time Frame
at baseline, Week 16, Week 32
Title
Immunologic Changes-M2 population
Description
Changes in M2 population in peripheral blood and nasal secretion (Flow cytometry).
Time Frame
at baseline, Week 16, Week 32
Title
Change of symptom scores
Description
Assessment data from all patients whom will record on diary cards their symptom scores based on visual analog scales.
Time Frame
at the pollen season of 2016, Week 16 and 6 months after discontinuation of treatment

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: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
Beijing Tongren Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China

12. IPD Sharing Statement

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Effect and Underlying Immunological Mechanisms of Sublingual Immunotherapy in Allergic Rhinitis

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