Clinical trial NCT03649139: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Seasonal Allergic Rhinitis
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
Collaborators: name: Zhejiang Wolwo Bio-Pharmaceutical Co., Ltd.
First posted: 2018-08-28
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: experiment:placebo=2:1
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: change from baseline symptom scores at Week 16
timeFrame: at baseline, Week 16
Secondary outcomes:
measure: Quality of life
timeFrame: at the pollen season of 2016, baseline, Week 16, Week 32, 6 months after discontinuation of treatment
measure: Medication scores
timeFrame: at the pollen season of 2016, baseline, Week 16, Week 32, 6 months after discontinuation of treatment
measure: Immunologic Changes-IgE
timeFrame: at baseline, Week 16, Week 32
measure: Immunologic Changes-M2 population
timeFrame: at baseline, Week 16, Week 32
measure: Change of symptom scores
timeFrame: at the pollen season of 2016, Week 16 and 6 months after discontinuation of treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital
state: Beijing
Study officials:
References: