Effect and Underlying Immunological Mechanisms of Sublingual Immunotherapy in Allergic Rhinitis

NCT ID: NCT03649139

Last Updated: 2019-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-01
• Study Completion Date: 2018-10-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

artemisia annua (sweet sagewort) allergen extract drops

Drug: sublingual immunotherapy drops

Group Type: ACTIVE_COMPARATOR

sublingual immunotherapy drops

Intervention Type: DRUG

artemisia annua (sweet sagewort) allergen extract drops

Placebo drops

Drug: sublingual placebo drops

Group Type: PLACEBO_COMPARATOR

Placebo drops

Intervention Type: DRUG

sublingual placebo drops

Interventions

sublingual immunotherapy drops

artemisia annua (sweet sagewort) allergen extract drops

Intervention Type: DRUG

Placebo drops

sublingual placebo drops

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Wolwo Bio-Pharmaceutical Co., Ltd.

UNKNOWN

Sponsor Role: collaborator

Beijing Tongren Hospital

OTHER

Sponsor Role: lead

Responsible Party

Luo Zhang

President, Beijing TongRen Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Tongren Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

TR-SLIT-IMMUNO

Identifier Type: -

Identifier Source: org_study_id