At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 18 enrolled
Drug / intervention
Sargramostim +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Inhaled GM-CSF Reduces the Need for Whole Lung Lavage and Improves Gas Exchange in Autoimmune PAP Patients
Fondazione IRCCS Policlinico San Matteo di Pavia·interventional·Posted May 13, 2009·Updated Jul 12, 2024
In Brief
A Phase 2 clinical trial evaluating Baseline WLL, Sargramostim, and 1 other intervention for Autoimmune Pulmonary Alveolar Proteinosis. Completed, enrolled 18 participants across 1 site.
Detailed 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 pulmonary alveolar proteinosis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
CollaboratorsAgenzia Italiana del Farmaco
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 2009
Enrollment StartJul 2009
Primary CompletionJun 2016
TodayJul 2026
First PostedMay 13, 2009
Enrollment StartJul 1, 2009
Primary CompletionJun 1, 2016
TodayJul 2, 2026
Enrollment to primary: 6.9 yearsPosted 17.1 years ago
Interventions
Baseline WLLprocedure
Scheduled bilateral WLL
Sargramostimdrug
Inhaled GM-CSF
Rescue WLLprocedure
Unscheduled bilateral WLL