Clinical Research Directory

Inclusion Criteria: Eligible patients must: 1. Be ≥18 years of age at the time of signing the informed consent. 2. Agree to use a highly effective form of contraception (see Section 3.5). 3. Have a positive serum anti-granulocyte macrophage colony-stimulating factor (GM CSF) autoantibody test result confirming aPAP. 4. Have a history of pulmonary alveolar proteinosis (PAP), based on examination of a lung biopsy, bronchoalveolar lavage (BAL) cytology, or a high-resolution computed tomogram (HRCT) of the chest. 5. Have at least one symptom of aPAP, including but not limited to dyspnea (at rest or with exertion), cough, or fatigue. 6. Be capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. 7. Be willing and able to comply with the visit schedule and treatment plan specified in the protocol, as judged by the physician. Exclusion Criteria: Eligible patients must not: 1. Have a diagnosis of hereditary or secondary PAP, or a metabolic disorder of surfactant production. 2. Require a whole lung lavage (WLL) at the time of screening (patient may be eligible 1 week post WLL). 3. Have received GM-CSF treatment within 1 month prior to the screening visit. 4. Have been treated with any investigational product within 5 half-lives or 3 months (whichever is longer) prior to the screening visit. 5. Have a history of allergic reactions to GM-CSF or any of the excipients in the nebulizer solution. 6. Be using significant (e.g., more than 10 mg/day systemic prednisolone) immunosuppression. 7. Have a history of severe and unexplained side effects during aerosol delivery of any medicinal product. 8. Have a history or current diagnosis of a myeloproliferative disease or leukemia. 9. Have any other medical condition which in the opinion of the physician would make the patient unsuitable for treatment with molgramostim nebulizer solution. 10. Be pregnant or breastfeeding, or planning to become pregnant during treatment with molgramostim nebulizer solution.