EUCTR2014-001662-94-LT进行中（未招募）1 期
A Double-Blind, Randomised, Placebo-Controlled, Multi-Centre Field Study to Assess the Efficacy and Safety of HDM-SPIRE in Subjects with a History of House Dust Mite-Induced Rhinoconjunctivitis - Phase II HDM-SPIRE safety and efficacy study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 660
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
- •- Male or female, aged 18-70 years.
- •- A reliable history consistent with moderate to severe rhinoconjunctivitis (sneezing, rhinorrhoea, itchy nose, nasal blockage and/or itchy eyes, red eyes, watering eyes and/or itchy ear/palate) on exposure to HDM for at least 1 year and which has required symptomatic treatment on at least one occasion during the last year.
- •- Mean TRSS =10 from 4 nasal and 4 non-nasal symptoms over a consecutive 7 day period before the Screening Visit 1B/C.
- •- Either Der p or Der f specific IgE =0.35 kU/L measured by ImmunoCAP®.
- •- Positive skin prick test (preferably using the ALK-Abello Allergen Extract test) to either Der p or Der f with a wheal diameter at least 5 mm (average of longest and orthogonal) larger than that produced by the negative control. The negative control must be <2 mm for the test to be valid.
- •- Provide written informed consent.
- •Additional Inclusion Criteria at End of BAE
- •- Mean TRSS =12 from 4 nasal and 4 non-nasal symptoms during the BAE period (3-week period before randomisation).
- •- Completed the eDiary during the BAE on at least 16 days (>75% of occasions).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 640
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •- Diagnosis of asthma requiring GINA Step 3 or higher treatment.
- •- If asthmatic, experienced a deterioration of asthma that resulted in emergency treatment or hospitalisation in the 12 months before randomisation, or experienced a lifethreatening asthma attack (e.g. one requiring intubation and mechanical ventilation) at any time in the past.
- •- Used any oral or parenteral corticosteroids at any time within 1 month prior to Screening Visit 1B/C.
- •- Asthma requiring high-dose inhaled corticosteroids (ICS) or anti-IgE therapy within 6 months prior to Screening Visit 1B/C.
- •- Forced expiratory volume in 1 second (FEV1) <80% of predicted, or other evidence of partly controlled or uncontrolled asthma.
- •- Clinically significant confounding symptoms of allergy to relevant local seasonal allergens (e.g. ragweed, mugwort, tree, grass or mould) and cannot complete the BAE and the final PAC period at 50-52 weeks (PAC3) outside the respective allergy seasons.
- •- IgE =0.35 kU/l to other perennial allergens (e.g. animal dander, cockroach, mould) which cannot be avoided during the study or where sampling for these allergens demonstrates significant levels within the subject’s home from dust and/or vacuum cleaner samples, analysed using Indoor Biotechnologies Allergen Analysis Service.
- •- Intends to be away for 7 days or more during the final PAC period at 50-52 weeks (PAC3), or whose lifestyle means that there is a high likelihood of them
- •being away from home for more than 7 days during the PAC3 period.
- •- Received an immunosuppressive treatment within 3 months prior to screening (except steroids for allergic and asthma symptoms).
- •- Previous immunotherapy treatment with any HDM allergen for more than 1 month within 5 years prior to screening.
- •- History of significant recurrent acute sinusitis, defined as 2 episodes per year for the last 2 years, all of which required antibiotic treatment, or a history of chronic sinusitis, defined as sinus symptoms lasting greater than 12 weeks that include 2 or more major factors or 1
- •major factor and 2 minor factors. Major factors are defined as facial pain or pressure, nasal obstruction or blockage, nasal discharge or purulence or discoloured postnasal discharge, purulence in nasal cavity, or impaired or loss of smell. Minor factors are defined as headache, fever, halitosis, fatigue, dental pain, cough, and ear pain, pressure, or fullness.
- •Additional Exclusion Criteria at end of BAE
- •- Used any oral or parenteral corticosteroid during the BAE period.
研究者
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