EUCTR2017-004219-37-DE进行中（未招募）1 期
A randomized, prospective, multicenter, controlled and double-blinded Phase II Clinical Trial to evaluate the influence of inhaled Aviptadil on Cough and Quality of Life in Sarcoidosis patients - Avisarco II
niversitätsklinikum Freiburg, Leitender Ärztlicher Direktor0 个研究点目标入组 200 人开始时间: 2020年7月29日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
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.Adult male and female patients = 18 years of age
- •2.Patient with sarcoidosis and associated chronic cough (LCQ score < 16), any Scadding type, any other organ manifestation as long as it does not require prednisolone therapy > 15 mg, see exclusion criteria 3)
- •3.Body mass index (BMI) <30 kg/m2
- •4.Patients supposed to be kept on stable medication for the whole study period
- •5.Written informed consent obtained according to international guidelines and local laws
- •6.Negative results for HIV, hepatitis A, B and C within three months prior to study inclusion
- •7.Ability to understand the nature of the trial and the trial related procedures in German and to comply with them
- •8.Ability to use the nebulizer in a proper manner
- •9.Ability to store the IMP according to requirements
- •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 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •1.Patients suffering from other organic causes of cough (e.g. respiratory tract infections, gastroesophageal reflux disease, heart failure, bronchitis associated with any other disorder but sarcoidosis, thoracic tumors, exposure to inhalable irritants, laryngitis etc)
- •2.Patients treated with ACE-inhibitors or a history of ACE-inhibitor treatment within the last six weeks (ACE-inhibitors are also not allowed to start during the study)
- •3.Corticosteroids doses > 15 mg prednisolone equivalent per day
- •4.Immunosuppressive treatment (except for corticosteroids = 15 mg prednisolone equivalent per day) within 3 months prior randomisation or indications to start or intensify immunosuppressive therapy during the study
- •5. Patients suffering from other chronic or acute severe diseases besides sarcoidosis manifestations that might impair safe participation in the trial according to the treating physician, e.g.:
- •-Chronic kidney disease (CKD) stage 4 and 5
- •-Liver cirrhosis Child-Pugh score B and C
- •-Intended surgery of heart, lung, liver or abdominal disease during the trial period
- •-Active malignancies requiring chemo- and / or radiotherapy
- •-Chronic bowel diseases not sufficiently controlled
- •6.Conditions or medications supposed to influence the primary or secondary outcomes according to the local investigator’s appraisal (e.g. newly diagnosed obstructive sleep apnoea syndrome, newly or recently exacerbated psychiatric disease, modification of psychotic disease)
- •7.Known HIV infection, infectious hepatitis (type A, B or C) or another currently uncontrolled infection
- •8.Known hypersensitivity to the active substance or any of the excipients
- •9.Participation in any other interventional clinical trial during this study or during the last 30 days prior to informed consent; simultaneous participation in registry and diagnostic trials is allowed
- •10.Previous participation in this trial
- •11.Known persistent abuse of medication, drugs or alcohol
- •12.Relationship of dependence/employment with the sponsor or the investigator
- •13.Current or planned pregnancy, nursing period or patients of reproductive potential who are not using effective birth control methods
- •14.Male subjects with reproductive potential who refuse to use adequate means of contraception during and up to 90 days after stopping treatment with Aviptadil
研究者
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