Effect and Underlying Immunological Mechanisms of Sublingual Immunotherapy in Allergic Rhinitis

NCT03649139 | Completed Phase 3

• 1 other identifier: TR-SLIT-IMMUNO
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Seasonal Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• 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).

  at baseline, Week 16

Secondary Outcomes (5)

• Quality of life

  at the pollen season of 2016, baseline, Week 16, Week 32, 6 months after discontinuation of treatment

• Medication scores

  at the pollen season of 2016, baseline, Week 16, Week 32, 6 months after discontinuation of treatment

• Immunologic Changes-IgE

  at baseline, Week 16, Week 32

• Immunologic Changes-M2 population

  at baseline, Week 16, Week 32

• Change of symptom scores

  at the pollen season of 2016, Week 16 and 6 months after discontinuation of treatment

Study Arms (2)

artemisia annua (sweet sagewort) allergen extract drops

ACTIVE COMPARATOR

Drug: sublingual immunotherapy drops

Drug: sublingual immunotherapy drops

Placebo drops

PLACEBO COMPARATOR

Drug: sublingual placebo drops

Drug: Placebo drops

Interventions

sublingual immunotherapy drops DRUG

artemisia annua (sweet sagewort) allergen extract drops

artemisia annua (sweet sagewort) allergen extract drops

Placebo drops DRUG

sublingual placebo drops

Placebo drops

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tongren Hospital: lead
• Zhejiang Wolwo Bio-Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Beijing Tongren Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President, Beijing TongRen Hospital

Model Details: experiment:placebo=2:1

Study Record Dates

• First Submitted: August 2, 2018
• First Posted: August 28, 2018
• Study Start: April 1, 2017
• Primary Completion: October 30, 2018
• Study Completion: October 30, 2018
• Last Updated: June 11, 2019

Record last verified: 2019-06

Locations

CN (1)