Inhaled GM-CSF Therapy of Autoimmune PAP (NCT00901511) | Clinical Trial Compass
CompletedPhase 2
Inhaled GM-CSF Therapy of Autoimmune PAP
Italy18 participantsStarted 2009-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
What they're measuring
1
Time to Rescue WLL
Timeframe: 30 months
Trial details
NCT IDNCT00901511
SponsorFondazione IRCCS Policlinico San Matteo di Pavia