The IMPALA-2 autoimmune pulmonary alveolar proteinosis (aPAP) trial
Breathing new life into aPAP research
Thank you for your interest in this clinical trial.
Or email patientinfo@savarapharma.com
or call 512-614-1847
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.
Can you participate?
You may be able to take part in the IMPALA-2 trial if you have aPAP and you:
- Are at least 18 years of age (must be at least 20 years of age if participating in Japan)
- Have not had whole lung lavage therapy within the last 3 months
Participants must meet additional criteria to participate in the trial.
Interested in the trial?
The trial is being conducted at locations within North America, Japan, Australia, South Korea and approximately 15 countries across Europe. Find a site near you below and talk with your doctor about this aPAP clinical trial.
Or email patientinfo@savarapharma.com
or call 512-614-1847
- Canada
- United States
- Ireland
- United Kingdom
- Portugal
- Spain
- France
- Belgium
- Netherlands
- Germany
- Italy
- Poland
- Romania
- Greece
- Turkey
- South Korea
- Japan
- Australia
Or email patientinfo@savarapharma.com
or call 512-614-1847
IMPALA-2 aPAP Clinical Trial FAQs
Where is the trial being conducted?
The trial is being conducted within North America, Japan, Australia, South Korea and approximately 15 countries across Europe. To find a clinical site near you, click here, email patientinfo@savarapharma.com, or call 512-614-1847.
How is the investigational treatment taken during this clinical trial?
The investigational treatment is taken by inhalation once per day via a nebulizer.
Has the potential treatment that is being studied been studied in aPAP patients before?
Yes, two other previous clinical trials have been conducted. There has been a trial in healthy volunteers, as well as a trial in patients with aPAP (138 patients) which demonstrated improvement in clinical outcomes in patients with aPAP.
What is the goal of this trial?
The IMPALA-2 clinical trial is looking at whether the investigational drug, molgramostim nebulizer solution (molgramostim), is safe and effective in adults living with aPAP.
Do I need health insurance to participate in this clinical trial?
No. Health insurance is not required to participate in this trial. Trial-related treatment, and comprehensive health checks specific to the trial, will be provided at no cost if you qualify for IMPALA-2.
How long will the trial last?
The trial will last up to 96 weeks. For the first 48 weeks of the trial (Period 1), trial participants will be randomly assigned by a computer to receive either molgramostim or placebo. During the second 48 weeks of the trial (Period 2) all participants will receive molgramostim.
Is there any cost for me to participate in the clinical trial?
There is no charge for your participation in this trial and trial-related travel reimbursement may be available for eligible patients.
What do I do if I’m interested in the clinical trial?
If you are interested in the trial, please view the map to see if the trial is open in your country then click find a clinical trial site near you and speak with your doctor about potential next steps.
How do I know if I am eligible for the clinical trial?
The trial has specific guidelines (eligibility criteria) spelling out who can participate. For this trial, you must be at least 18 years of age (must be at least 20 years of age if participating in Japan) and not had whole lung lavage therapy within the last 3 months. To understand if you meet eligibility requirements, reach out to your healthcare provider.
