Safety Extension Trial of Inhaled Molgramostim in Autoimmune Pulmonary Alveolar Proteinosis

Exclusion Criteria

• •Treatment with GM-CSF products other than molgramostim nebuliser solution within three months of Baseline.
• •Treatment with any investigational medicinal product other than inhaled molgramostim within four weeks of Baseline.
• •History of allergic reactions to GM-CSF.
• •Connective tissue disease, inflammatory bowel disease or other autoimmune disorder requiring treatment associated with significant immunosuppression, e.g. more than 10 mg/day systemic prednisolone.
• •Previous experience of severe and unexplained side effects during aerosol delivery of any kind of medicinal product.
• •History of, or present, myeloproliferative disease or leukaemia.
• •Apparent pre-existing concurrent pulmonary fibrosis.
• •Any other serious medical condition which in the opinion of the investigator would make the subject unsuitable for the trial.