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Completed

NCT Number: NCT03649139

Effect and Underlying Immunological Mechanisms of Sublingual Immunotherapy in Allergic Rhinitis

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.

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing Tongren Hospital

Beijing, Beijing Municipality, 100730, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

sublingual immunotherapy drops

Drug

artemisia annua (sweet sagewort) allergen extract drops

Placebo drops

Drug

sublingual placebo drops

Primary outcomes

  1. 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).

Secondary outcomes

  1. Quality of life

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

    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).

  2. Medication scores

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

    Assessment data from all patients whom will record on diary cards their medication usage.

  3. Immunologic Changes-IgE

    Time frame: at baseline, Week 16, Week 32

    Changes in total serum IgE, specific IgE levels in peripheral blood.

  4. Immunologic Changes-M2 population

    Time frame: at baseline, Week 16, Week 32

    Changes in M2 population in peripheral blood and nasal secretion (Flow cytometry).

  5. Change of symptom scores

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

    Assessment data from all patients whom will record on diary cards their symptom scores based on visual analog scales.

Sponsors and collaborators

Lead sponsor

Beijing Tongren Hospital

Other

Collaborators

  • Zhejiang Wolwo Bio-Pharmaceutical Co., Ltd.

Registry information

Official study title

Effect and Underlying Immunological Mechanisms of Sublingual Immunotherapy in Seasonal Allergic Rhinitis: a Randomized, Double Blind, Placebo Controlled Trial

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 28, 2018
Registry last updated
Jun 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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