Pulmonary Fibrosis categorized as UIP or NSIP
Conditions
Interventions
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 microgr
Sponsors
Mondobiotech Laboratories Anstalt
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: ?Lack of consent ?Pregnancy and lactation ?Presumed non-cooperativeness ?Malignant diseases in anamnesis ?Legal incapacity ?Parallel participation in another clinical trial or participation in any other trial within the previous 30 days ?Clinical instability in form of general symptoms of fibrosis such as fever (= 38oC), fatigue or weakness or hypoxemia under oxygen supplementation (= 60 mmHg oxygen, international standards exclude patients with =55mmHg). ?Respiratory insufficiency identified by hypoxemia (PaO2 = 50 mmHg breathing room air) and/or reduction of vital capacity to less or equal of 40% predicted ?Allergy or hypersensitivity against Aviptadil or any other compound present in the aerosol to be inhaled
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Influence of inhaled Aviptadil on CCL18 serum concentrations 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 ;Primary end point(s): Decrease of the plasma concentration of CCL-18 in patients with Pulmonary Fibrosis | — |
Countries
Germany
Outcome results
None listed