Status:
COMPLETED
Inhaled GM-CSF Therapy of Autoimmune PAP
Lead Sponsor:
Fondazione IRCCS Policlinico San Matteo di Pavia
Collaborating Sponsors:
Agenzia Italiana del Farmaco
Conditions:
Autoimmune Pulmonary Alveolar Proteinosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a prospective, randomized, open-label, long-term, phase 2 study of inhaled granulocyte/macrophage-colony stimulating factor following whole lung lavage therapy in patients with autoimmune pulm...
Detailed Description
Autoimmune pulmonary alveolar proteinosis (aPAP) is a rare disorder of progressive surfactant accumulation and resulting hypoxemic respiratory failure caused by disruption of granulocyte/macrophage-co...
Eligibility Criteria
Inclusion
- Female of male 18 years of age or older
- Diagnosis of autoimmune PAP
- Able and willing to provide written informed consent
- Eligible for whole lung lavage determined as the presence of persistent or progressive respiratory failure (PaO2 at rest \< 60 mm Hg) or desaturation \< 90% or \> 5 percentage points during standard exercise
Exclusion
- Diagnosis with secondary PAP, congenital PAP, or hereditary PAP
- Contraindication to whole lung lavage
- Contraindication to administration of inhaled GM-CSF
- Chronic lung disease associated with already existing respiratory failure, such as emphysema or pulmonary fibrosis, chronic heart failure, ischemic heart disease, active pulmonary embolism, progressive cancer, and other severe metabolic conditions
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00901511
Start Date
July 1 2009
End Date
June 1 2016
Last Update
July 12 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Fondazione IRCCS Policlinico San Matteo
Pavia, PV, Italy, 27100