2024-513124-41-00招募中3 期
Influencing Progression of Airway Disease in Primary Antibody Deficiency
Universitair Medisch Centrum Utrecht3 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年7月12日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Difference in mean AD and ILD scores (as measured with CT scanning) between t=0 and t=2 years in patients with standard vs higher Ig replacement therapy dosing.
研究概览
简要总结
To show the protective value and to measure cost effectiveness of higher Ig dosing on progression of lung disease in PAD.
入排标准
- 年龄范围
- 0 years 至 64 years（18-64 Years, 0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Age 8-60 years
- •Diagnosis of Primary Antibody Deficiency / Common Variable Immunodeficiency Disorder (see Appendix I protocol)
- •Indication for immunoglobulin replacement therapy and/or treated with immunoglobulin replacement therapy
- •Current IgG dosing 0.25 - 0.6 gr / kg / 3-4 weeks
- •Receiving treatment and follow-up for PAD by a physician in one of the participating centers
- •Written informed consent
排除标准
- •Diagnosis of Combined Immunodeficiency (CID) disease at onset of study (see Appendix 1). Explanation: Combined Immunodeficiency is featured by the occurrence of more viral infections and reactivations and thus less comparable to PAD.
- •Severe pulmonary disease, determined by an independent radiologist: a. Baseline AD score > 7 and/or ILD score > 5, in combination with: i. Saccular bronchiectasis on CT scan, or; ii. Clinical diagnosis of severe respiratory insufficiency ( (defined as: saturations in room air <92%, and/ or oxygen dependency). b. Baseline pulmonary function (FEV1 and FVC) <70% expected for age and body weight / length)
- •Active smoker
结局指标
主要结局
Difference in mean AD and ILD scores (as measured with CT scanning) between t=0 and t=2 years in patients with standard vs higher Ig replacement therapy dosing.
Difference in mean AD and ILD scores (as measured with CT scanning) between t=0 and t=2 years in patients with standard vs higher Ig replacement therapy dosing.
次要结局
- Number of upper- and lower respiratory tract infections before onset of study and during study, i.e.: Sino pulmonary disease, otitis, pneumonia, collected by study CRF's.
- Pulmonary symptoms will be evaluated on a daily basis (during two periods of 2 months) using a diary that can be directly entered in Castor.
- Days missed from school and work due to infections, measured by the PCQ (productivity cost questionnaire) instrument.
- Quality of life, measured with the EQ-5D questionnaire
- Ig dosing and IgG trough levels in intervention and in control group
- Total health costs (consisting of costs for health care professional visits, medication, hospitalizations, imaging and biochemical investigations) in intervention and control group, collected from electronic patient files.
- Immunological laboratory phenotype, collected from electronic patient files.
- Adverse events: reporting and monitoring of patients and Adverse Events (AEs), Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reaction (SUSARs) will be done by an independent monitor.
研究者
dr. J.M. van Montfrans
Scientific
Universitair Medisch Centrum Utrecht
研究点 (3)
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