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Whole lung lavage followed by inhaled Sargramostim in the treatment of autoimmune pulmonary alveolar proteinosis. - WLL/inhaled GM-CSF in autoimmune PAP

Whole lung lavage followed by inhaled Sargramostim in the treatment of autoimmune pulmonary alveolar proteinosis. - WLL/inhaled GM-CSF in autoimmune PAP

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-007086-23-IT
Enrollment
Unknown
Registered
2009-01-27
Start date
2008-12-12
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune PAP MedDRA version: 9.1 Level: LLT Classification code 10037316 Term: Pulmonary alveolar proteinosis

Interventions

Trade Name: Leukine Pharmaceutical Form: Solution for injection INN or Proposed INN: Sargramostim Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: .5-

Sponsors

OSPEDALE POLICLINICO S. MATTEO
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: autoimmune PAP diagnosis; age >= 18 years; persistant or progressive respiratory failure (PaO2 5% in Bruce`s test) or persistant pulmonary TC abnormalities (intensity score >=3) (reasidual disease treated group) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: non autoimmune PAP; contraindications to WLL; contraindication to GM-CSF; pregnancy; refusal to the use of contraceptive methods during the study period; contraindications to the use of inhaled medicines.

Design outcomes

Primary

MeasureTime frame
Main Objective: Total resolution of the disease in 100% of patients treated with WLL/inhaled GM-CSF.;Secondary Objective: 1)to avoid recurrence of the disease requiring multiple WWL, 2) to avoid or reduce the number of respiratory infections due to persistant pulmonary abnormalities PAP associated 3) evaluation of outcome determinants in the diverse treated groups, 4) ancillary study to establish whether the addition of inhaled GM-CSF may influence PAP pathophysiology.;Primary end point(s): Primary efficacy endpoint (total resolution of disease in 100% of patients trated with WLL/inhaled GM-CSF) will be documented as follows: a. functional endpoints: measuere of alveolar-arterial oxygen tension gradient (PA-a O2), measure of oxygen saturation during exercise, according to the modified Bruce`s protocol. b. Imaging endpoint: score of the pulmonary CT performed after 3 and 10 months after WLL. c. Severity score: score based on symptoms and PaO2 level at entry. The score will be associated to a quality of life questionnaire (SF36).—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026