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Effect and Underlying Immunological Mechanisms of Sublingual Immunotherapy in Allergic Rhinitis

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ClinicalTrials.gov Identifier: NCT03649139
Recruitment Status : Completed
First Posted : August 28, 2018
Last Update Posted : June 11, 2019
Sponsor:
Collaborator:
Zhejiang Wolwo Bio-Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Luo Zhang, Beijing Tongren Hospital

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.


Condition or disease Intervention/treatment Phase
Seasonal Allergic Rhinitis Drug: sublingual immunotherapy drops Drug: Placebo drops Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: experiment:placebo=2:1
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect and Underlying Immunological Mechanisms of Sublingual Immunotherapy in Seasonal Allergic Rhinitis: a Randomized, Double Blind, Placebo Controlled Trial
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : October 30, 2018
Actual Study Completion Date : October 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hay Fever

Arm Intervention/treatment
Active Comparator: artemisia annua (sweet sagewort) allergen extract drops
Drug: sublingual immunotherapy drops
Drug: sublingual immunotherapy drops
artemisia annua (sweet sagewort) allergen extract drops

Placebo Comparator: Placebo drops
Drug: sublingual placebo drops
Drug: Placebo drops
sublingual placebo drops




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03649139


Locations
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China, Beijing
Beijing Tongren Hospital
Beijing, Beijing, China, 100730
Sponsors and Collaborators
Beijing Tongren Hospital
Zhejiang Wolwo Bio-Pharmaceutical Co., Ltd.

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Responsible Party: Luo Zhang, President, Beijing TongRen Hospital, Beijing Tongren Hospital
ClinicalTrials.gov Identifier: NCT03649139     History of Changes
Other Study ID Numbers: TR-SLIT-IMMUNO
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Immunologic Factors
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Physiological Effects of Drugs