A Bridging Study Investigating the Diagnostic Equivalence of the SPT Tape in Comparison With the Conventional SPT Using ALK SoluprickR Allergen Extracts in Patients With Inhalation Allergy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 75
- 主要终点
- Wheal diameters
研究概览
简要总结
Testing of a new ready-to-use Tape in comparison to the currently used skin prick test for the diagnosis of allergies. Assessment of clinical equivalence of the SPT Tape for representative common inhalant allergens to conventional SPT in terms of wheal reaction positivity and overall safety. Tests are performed in patients who have a medical history of relevant allergic rhinitis to any of the tested allergens.
详细描述
An open-label, single site bridging study. Subjects with a history of in-halation allergies will be tested in parallel with the SPT Tape and with the conventional SPT procedure using one forearm each.
In each patient, a panel of 8 allergens with the SPT Tape and with the conventional SPT is applied on the two forearms one time only.
The following Soluprick® allergens and control solutions will be evaluated:
Positive control, negative control, Phleum pratense, birch, Dermatophagoides pteronyssinus, D. farinae, dog dander, cat dander, mugwort, Alternaria sp. The allergens used for the SPT and the SPT Tape are identical Soluprick allergen solutions; allergens will be applied in the same location and order on both arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects will be included only, if
- •they were informed about the nature, meaning, and scope of the study, and if they provided written consent to their participation
- •they are at least 18 years of age,
- •they have a history of allergic rhinitis due to grass and/or birch pollen, house dust mites, mugwort, cat and/or dog dander, and/or Alternaria since 2 years or more
排除标准
- •Subjects may not be included, if
- •they are impaired in understanding nature, meaning, and the scope of the study, or are incapable of giving written informed consent,
- •they suffer from diseases, show other conditions, or take medications, which might impact the skin tests or might contradict the correct conduct and evaluation of the study. In particular this includes the following:
- •acute allergy,
- •history of systemic reactions or hypersensitivity to allergens, abuse of drugs or alcohol
- •severe diseases,
- •impaired reactivity of the skin (e.g. hyperkeratosis, ichthyosis, urticaria factitia) and acute chronic eczema in the skin test areas, skin infections,
- •pregnancy or nursing,
- •treatment with β-blockers,
- •treatment with antihistamines or systemic glucocorticoids during the last 4 weeks, with astemizol during the last 12 weeks,
- •treatment with tricyclic antidepressants benzodiazepines, and neuroleptic drugs which may have histamine-antagonistic effects during the last 2 weeks,
- •participation in any other medication study at the study time
研究组 & 干预措施
Skin Prick Test TAPE
The Skin Prick Test Tape is an innovative sterile "all-in" drug carrying 8 allergens and 2 control solutions including prick needles in one Tape for easy use and standardization. Single use. Reading of wheal reactions after 15 minutes, facilitated by stripes with the allergen names.
干预措施: Skin Prick Test TAPE (Diagnostic Test)
Skin Prick Test
The conventional SPT is the world-wide standard in allergy Type 1 diagnosis for inhalant and food allergens. Drops of allergens are applied to the forearm and, with the help of a lancet, brought into the skin. Reading of wheal reactions after 15 minutes.
干预措施: Skin Prick Test (Diagnostic Test)
结局指标
主要结局
Wheal diameters
时间窗: 15 min
Maximal wheal diameter in millimeter
次要结局
- Visual Analogue Scale on Comfort(30 min)
- Patient' s preference(30 min)