EUCTR2014-004223-46-ES进行中（未招募）1 期
A randomized, double-blind, placebo-controlled, multi-center study of the efficacy and safety of STG320 sublingual tablets of house dust mite (HDM) allergen extracts in adults and adolescents with HDM-associated allergic rhinitis
Stallergenes S.A.0 个研究点目标入组 990 人开始时间: 2015年8月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 990
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Have house dust mite (HDM)-associated allergic rhinitis (AR) (with or without asthma) for at least 1 year based on the presence of:
- •? Symptoms for 4 or more consecutive weeks in the previous year and for at least 4 days per week during those weeks.
- •? Symptoms requiring regular intake of symptomatic treatment(s).
- •? Symptoms evaluated as ?troublesome? by the patients or impairing their daily activities, leisure or sport, school or work or involving sleep disturbance.
- •2. Have given signed informed consent to participate, after having been informed of the nature and aims of the study, in accordance with local regulation and requirements.
- •3. Male or female outpatients 12 to 65 years of age.
- •4. Sensitized to D. pteronyssinus (D. pte) and/or D. farinae (D. far) defined as skin prick test wheal diameter at least 5 mm greater than the negative control and HDM-specific serum IgE ?3.5 kU/L.
- •5. Willing to and capable of completing the e-diary, study questionnaires and scales.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 100
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 890
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. A history of rhinitis, rhino-conjunctivitis or asthma to allergens other than HDM, likely to result in rhinitis symptoms during the baseline and primary evaluation periods (i.e., 4 weeks of evaluation between September and January).
- •Specifically, when the following are present:
- •? documented sensitization (positive Skin Prick Test or allergen specific serum IgE >3.5kU/L) and history of clinically relevant symptoms to allergen(s) other than HDM
- •? anticipated exposure to such allergen(s) during the baseline and primary evaluation periods (i.e., the 4 weeks of evaluation between September and January)
- •For example, the following patients are to be excluded:
- •- patients sensitized to cat or dog allergens and regularly exposed to these animals
- •- patients sensitized to perennial allergens, such as aspergillus, cladosporium, alternaria, cockroach
- •- patients sensitized to seasonal allergens such as parietaria, ragweed or mugwort, if these allergens are endemic in the region during the baseline and primary evaluation periods.
- •2. Any diagnosed nasal (other than HDM allergic rhinitis) or oral disease that could interfere with the efficacy or safety assessments, such as nasal polyposis, recurrent chronic rhino-sinusitis (at least 2 isolated episodes per year in the 2 previous years, each episode lasting more than 8 weeks) or a history of chronic oral inflammation or current active oral inflammation from any etiology (e.g., oral lichen planus, oral ulceration or oral mycosis) and/or oral wounds.
- •3. Recent nasal surgery (i.e., within the previous 6 months).
- •4. Partially controlled or uncontrolled asthma defined in the Global Initiative for Asthma 2014 guidelines (GINA 2014) as the presence of daytime asthma symptoms more than twice/week or nocturnal symptoms/awakening or need for reliever/rescue treatment more than twice/week or FEV1 <80% of predicted or personal best value.
- •5. Asthma therapies consistent with GINA treatment Step 3, Step 4 and Step 5 i.e., the preferred controller medication consists of inhaled corticosteroid (ICS) combined with long-acting beta (?)-2 agonist (LABA) according to GINA classification 2014 (refer to Appendix II for the full details of other controller options).
- •6. Experienced a life-threatening asthma attack or an asthma exacerbation that resulted in Intensive Care Unit (ICU) hospitalization.
- •7. Requiring continuous treatment with systemic corticosteroids for any indication.
- •8. Requiring continuous treatment with ?-blockers or with Monoamine Oxidase Inhibitors (MAOIs).
- •9. Received an immunosuppressive treatment within 3 months prior to screening.
- •10. Received allergen specific immunotherapy (AIT) by any route:
- •- for house dust mites: AIT for more than 1 month within the 5 years before screening
- •- for other allergen(s): ongoing or recently stopped (within 6 months) AIT.
- •11. Any history of anaphylaxis after previous allergen immunotherapy, exposure to allergen(s) or of unknown cause.
- •12. Any history of hypersensitivity to STG320 or its excipients or contraindication to the use of rescue medications
- •13. Female with positive urine pregnancy test or lactating or expecting to conceive within the duration of the study.
- •14. Sexually active female of child-bearing potential without medically accepted contraceptive method
- •15. Unable or unwilling to comply with the study protocol requirements, including those who anticipate significant changes in their daily environment in relation to HDM exposure or who are likely to travel
研究者
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