IMPALA -2
Research type
Research Study
Full title
A randomized, double-blind, placebo-controlled clinical trial of once-daily inhaled molgramostim nebulizer solution in adult subjects with autoimmune pulmonary alveolar proteinosis (aPAP)
IRAS ID
289012
Contact name
Maria Kokosi
Contact email
Sponsor organisation
Savara ApS
Eudract number
2020-001263-85
Duration of Study in the UK
4 years, 3 months, 24 days
Research summary
The main purpose of IMPALA-2 is to further investigate the efficacy and safety of the trial drug and whether it improves function of the lungs in patients with aPAP. This will be done by measuring the lungs’ ability to transfer oxygen from inhaled air to the red blood cell. During the study, patients will be asked about their well-being to investigate if molgramostim improves the patients’ quality of life. The ability to perform exercise will be investigated using a treadmill walking test and the safety of inhaled molgramostim will also be investigated.
The trial consists of a 6-week screening period, a 48-week randomized, double-blind treatment period, a 48-week open-label treatment period, and a 2-week safety follow-up period.
The trial drug, Molgramostim is human GM-CSF that has been produced in bacteria. Savara’s molgramostim solution has been designed specifically for inhalation.
Subjects will receive once-daily treatment with either molgramostim 300 µg nebulizer solution (MOL) or placebo nebulizer solution (PBO) during the double-blind period, and trial visits will be conducted at 6-weekly intervals. Subjects who complete the double-blind period will continue to the open label treatment period and will receive a once-daily treatment with molgramostim 300 µg nebulizer solution (MOL) and trial visits will be conducted every 12-weeks.
Participating subjects will be encouraged to contact the clinic between visits if they experience adverse events or worsening of aPAP, or if they have any other concerns.REC name
South West - Central Bristol Research Ethics Committee
REC reference
20/SW/0165
Date of REC Opinion
8 Dec 2020
REC opinion
Further Information Favourable Opinion