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

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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.