Influence of Inhaled Aviptadil on Quality of life in Sarcoidosis (Avisarco II)

结节病是一种慢性疾病，以多个器官的肉芽肿为特征，许多患者(但不是所有患者)的炎症过程是自限性的。持续的炎症和功能器官恶化(如肺功能、心脏或中枢神经系统受累)需要免疫抑制治疗。与器官受累无关，咳嗽是结节病中一个尚未解决的问题。患者支持组织(如德国Sarkoidosevereigung)强调咳嗽对患者生活质量(QOL)的影响。咳嗽通常被认为不需要免疫抑制治疗。然而，为了控制症状，这些患者通常会开始免疫抑制治疗。在吸入血管活性肠肽(VIP，aviptadil)的II期试验中，我们证明了VIP对结节样炎症、咳嗽和生活质量有显著的作用。因此，我们申请了一项随机对照试验，对患有结节病相关性咳嗽但不值得根据实际指南进行免疫抑制治疗的患者使用VIP吸入。研究的主要终点集中在由莱斯特咳嗽问卷(LCQ)测量的咳嗽；其德语翻译已在200名结节病患者队列中得到验证。由另一份新翻译和验证的问卷评估的生活质量将成为次要终点。本研究旨在为结节病患者忽视的症状建立一种新的治疗方法，对他们的生活质量产生负面影响。这项研究将获得必要的知识，以缩小NO和过度治疗宪法申诉之间的治疗差距。

Sarcoidosis is a chronic disease characterized by granulomas in multiple organs and an inflammatory process that is self-limiting in many but not all patients. Ongoing inflammation and functional organ deterioration (e.g. lung function, cardiac or CNS involvement) require an immunosuppressive therapy. Independently of organ involvement cough is an unmet problem in sarcoidosis. Patient support groups (e.g. Deutsche Sarkoidosevereinigung) emphasize the influence of cough on patients’ quality of life (QoL). Cough is generally not considered to require immunosuppressive therapy. Nevertheless, immunosuppressive therapy is often started in these patients for symptom control. In a phase II trial with inhaled vasoactive intestinal peptide (VIP, aviptadil) we demonstrated a striking effect of VIP on sarcoid inflammation, cough and QoL. Therefore we apply for a randomized, controlled trial using inhaled VIP in patients suffering of sarcoidosis-related cough but not meriting immunosuppressive therapy according to actual guidelines. The primary endpoint of the study focusses on cough as measured by the Leicester Cough Questionnaire (LCQ); its German translation has been validated in a cohort of 200 sarcoidosis patients. QoL assessed by another newly translated and validated questionnaire will be a secondary endpoint. This study aims to establish a new therapy for neglected symptoms in sarcoidosis patients negatively influencing their QoL. This study will gain knowledge necessary to close the therapeutical gap between no and overtreatment of constitutional complaints.