Stopped: SAV006-03 was initiated before the evaluation of the IMPALA study (NCT02702180) results. Considering these results and authority advice there would not be adequate efficacy and safety data from SAV006-03 and the study was terminated.
SAV006-03 is an open-label extension study for participants who had completed the IMPALA study. At the baseline visit, eligible participants may continue or re-start treatment with 300 µg inhaled molgramostim (recombinant human Granulocyte-Macrophage Colony Stimulating Factor; GM-CSF) administered intermittently in cycles of seven days molgramostim, administered once daily, and seven days off treatment. Participants will be treated with inhaled molgramostim for up to 36 months. During the trial, whole lung lavage will be applied as rescue therapy.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Number of Treatment-emergent Adverse Events (TEAEs)
Timeframe: 139 weeks
Number of Serious TEAEs
Timeframe: 139 weeks
Number of Treatment-emergent Adverse Drug Reactions (ADRs)
Timeframe: 139 weeks
Number of TEAEs Leading to Treatment Discontinuation
Timeframe: 139 weeks