The IMPALA-2 autoimmune pulmonary alveolar proteinosis (aPAP) trial
Breathing new life into aPAP research
Thank you for your interest in this clinical trial.
A clinical research trial is an important step towards finding potential future treatments for people with aPAP. If you decide to take part, you’ll be helping researchers and physicians understand this rare disease better and could, potentially, play an important role in improving healthcare for other people living with aPAP.
Why we’re doing this research
Autoimmune pulmonary alveolar proteinosis (aPAP) is a rare lung disease with no approved pharmacologic treatment options. The disease is characterized by the build-up of surfactant in the alveoli (air sacs) of the lungs leading to impaired oxygen transfer from the lungs to the blood.
People with aPAP may experience symptoms like shortness of breath and a decreased ability to exercise. Typically, shortness of breath is first observed upon exertion, but as the disease progresses, shortness of breath can be experienced even when a person is at rest. Cough, as well as episodes of fever, can also be experienced especially if secondary lung infection develops. In the long-term, the disease can lead to serious complications, including lung fibrosis and the need for lung transplant.
Details on the IMPALA-2 aPAP clinical trial
This clinical research trial is being carried out to discover whether molgramostim nebulizer solution:
- Is safe to take
- Can help to reduce the symptoms of aPAP
Clinical trial design
The IMPALA-2 trial is looking at whether the investigational drug, molgramostim nebulizer solution (molgramostim), is safe and effective for improving lung function in adults living with aPAP.
For the first 48 weeks of the trial (Period 1), molgramostim will be compared with placebo (which looks like molgramostim but does not contain the active ingredient). During the second 48 weeks of the trial (Period 2) all participants will receive molgramostim. Both molgramostim and placebo will be given on top of the current standard of care, which includes supplemental oxygen when required and rescue treatment with whole lung lavage, if needed.
During Period 1, trial participants will be randomly assigned by a computer to receive either molgramostim or placebo.
Trial-related treatment, and comprehensive health checks specific to the trial, will be provided at no cost if you qualify for IMPALA-2. Trial-related travel reimbursement may be available for eligible patients.
Approximately 160 people with aPAP will take part in IMPALA-2 trial centers across the globe.
Still have questions? Read our FAQs.
- United States
- United Kingdom
- South Korea