Influence of inhaled Aviptadil on CCL18 serum concentrations in patients with pulmonary fibrosis

INTERVENTION: Product Name: Aviptadil, 66 microgram/mL Pharmaceutical Form: Inhalation vapour, solution CAS Number: 40077‐57‐4 Other descriptive name: Vasoactive intestinal peptide Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 66.6‐ Pharmaceutical form of the placebo: Inhalation vapour, solution Route of administration of the placebo: Inhalation use CONDITION: Pulmonary Fibrosis categorized as UIP or NSIP PRIMARY OUTCOME: Main Objective: Influence of inhaled Aviptadil on CCL18 serum concentrations in patients with pulmonary fibrosis Primary end point(s): Decrease of the plasma concentration of CCL‐18 in patients with Pulmonary Fibrosis Secondary Objective: Influence of inhaled Aviptadil on TNF‐a concentration in BAL‐ cell culture supernatant; Influence of inhaled Aviptadil on pulmonary compliance.; Influence of inhaled Aviptadil on volumes of bodyplethysmography (residual volume, vital capacity, total lung capacity); Influence of inhaled Aviptadil on the quality of life as recorded in appropriate questionnaire forms (SF36, St. George’s Respiratory Questionnaire); 6‐minutes walking test; INCLUSION CRITERIA: ?Diagnosis: clinically active pulmonary fibrosis, based on clinical history, and lung biopsy, consistent with a histologic pattern of UIP or NSIP or a mixture of both. In addtion, the diagnosis IPF/UIP will also be accepted on the basis of the diagnostic criteria of the ATS/ERS consensus statement. ?Aged above 18 years ?Written consent ?Highly effective contraception in female patients of childbearing age ?Negative pregnancy test 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range