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Cytokine
Inhaled Molgramostim for Autoimmune Pulmonary Alveolar Proteinosis (IMPALA-2 Trial)
Phase 3
Waitlist Available
Led By Bruce Trapnell, Prof
Research Sponsored by Savara Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female
History of PAP, based on examination of a lung biopsy, bronchoalveolar lavage (BAL) cytology, or a high-resolution computed tomogram (HRCT) of the chest.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening (6-week) until follow-up visit (week 100)
Awards & highlights
IMPALA-2 Trial Summary
This trial will study whether a daily inhaled drug can improve aPAP, and will last for 96 weeks total.
Who is the study for?
Adults diagnosed with autoimmune pulmonary alveolar proteinosis (aPAP) who can perform certain physical tests without supplemental oxygen, have a history of PAP confirmed by specific lung tests, and are not on recent treatments like WLL or GM-CSF. They must be able to consent and follow trial procedures. Pregnant women, those with severe medical conditions or allergies to the treatment components, and individuals with other serious lung diseases are excluded.Check my eligibility
What is being tested?
The study is testing an inhaled solution called Molgramostim against a placebo in people with aPAP. Participants will use their assigned treatment daily for 48 weeks; afterwards, all subjects receive Molgramostim for another 96 weeks. The goal is to see if this drug helps improve lung function compared to no active treatment.See study design
What are the potential side effects?
Potential side effects of Molgramostim may include reactions at the site of inhalation such as coughing or throat irritation, general body discomforts like fatigue or headaches, possible immune system responses including allergic reactions, and respiratory symptoms.
IMPALA-2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am either male or female.
Select...
I have a history of PAP confirmed by lung tests or scans.
Select...
I am at least 18 years old, or 20 if I am in Japan.
Select...
I can stop using extra oxygen for tests like treadmill exercise, DLCO, and blood gas sampling.
IMPALA-2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from screening (6-week) until follow-up visit (week 100)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening (6-week) until follow-up visit (week 100)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline in percentage (%) predicted diffusing capacity of the lung for carbon monoxide (DLCO) to Week 24
Secondary outcome measures
Change from baseline in EC, expressed as peak METs to Week 48
Change from baseline in SGRQ Activity component score to Week 24
Change from baseline in SGRQ Activity from baseline to Week 48
+10 moreSide effects data
From 2019 Phase 2 trial • 139 Patients • NCT0270218033%
Cough
22%
Chest pain
15%
Nasopharyngitis
13%
Headache
11%
Dyspnoea
9%
Productive cough
7%
Alveolar proteinosis
7%
Weight increased
4%
Pyrexia
4%
Respiratory tract infection
4%
Back pain
4%
Arthralgia
4%
Dizziness
2%
Pneumonia bacterial
2%
Respiratory failure
2%
Pneumonia
2%
Aphasia
2%
Epilepsy
2%
Laryngeal oedema
100%
80%
60%
40%
20%
0%
Study treatment Arm
Double-blind Molgramostim Once Daily
Double-blind Molgramostim Intermittent
Double-blind Placebo
Open-label Molgramostim Intermittent
IMPALA-2 Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MolgramostimExperimental Treatment1 Intervention
Double-blind treatment with molgramostim nebulizer solution 300 µg once daily for 48 weeks, followed by open-label treatment with molgramostim nebulizer solution 300 µg once daily for 96 weeks
Group II: PlaceboPlacebo Group2 Interventions
Double-blind treatment with placebo nebulizer solution once daily for 48 weeks, followed by open-label treatment with molgramostim nebulizer solution 300 µg once daily for 96 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Molgramostim
2015
Completed Phase 2
~190
Find a Location
Who is running the clinical trial?
Savara Inc.Lead Sponsor
8 Previous Clinical Trials
589 Total Patients Enrolled
Bruce Trapnell, ProfPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati
Bruce Trapnell, MDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati
5 Previous Clinical Trials
243 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken any experimental drugs recently.Your lung function test shows that your ability to transfer oxygen is 70% or lower than expected.I need strong medication (more than 10 mg/day of prednisolone) for my autoimmune disease.I have not had plasmapheresis in the last 6 weeks.I have lung scarring not related to my current condition.Your oxygen level is above 85% when measured without using extra oxygen for 15 minutes.I am either male or female.I have a history of PAP confirmed by lung tests or scans.I am at least 18 years old, or 20 if I am in Japan.I have or had a blood disorder or leukemia.I have been treated with rituximab in the last 6 months.Your lung function, measured as % predicted DLCO, has changed by less than 15% during the screening period.I need a whole lung lavage.I have not received GM-CSF treatment in the last 6 months.I had a whole lung lavage within the last 3 months.I can stop using extra oxygen for tests like treadmill exercise, DLCO, and blood gas sampling.I have had severe reactions to any medicine given through inhalation.I cannot safely perform exercise tests due to a physical condition.I do not have heart or lung conditions worsened by exercise.You have a blood test showing you have a specific type of autoimmune lung disease called autoimmune PAP.I have been diagnosed with a rare lung condition related to surfactant production.I do not have any active infections that could interfere with the trial.You have shown a reduced ability to exercise on a treadmill test.
Research Study Groups:
This trial has the following groups:- Group 1: Molgramostim
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you please share other examples of research using Molgramostim?
"Currently, there are 46 clinical trials underway for Molgramostim with 6 in Phase 3. Most of these research studies are situated in Seattle, Washington; although, there are a total of 1896 locations running Molgramostim clinical trials."
Answered by AI
Is this test being conducted in numerous locations across Canada?
"There are 24 sites conducting this trial, including University Of Arkansas in Little Rock, University Institute of Cardiology and Respirology of Quebec in Québec, Washington U. in St. Louis in Saint Louis."
Answered by AI
How many participants are being allowed into this trial?
"In order to properly conduct this trial, we need 160 volunteers that fit the given criteria. Luckily, patients can choose to participate from University Of Arkansas in Little Rock, Arkansas or University Institute of Cardiology and Respirology of Quebec in Québec, Missouri."
Answered by AI
Has Molgramostim been given the okay by the FDA?
"Molgramostim falls into the category of a Phase 3 trial, which means that there is efficacy data as well as multiple rounds of safety data. Therefore, it received a score of 3 from our team at Power."
Answered by AI
Are patients being enrolled in this experiment at the moment?
"That is correct. The clinical trial, which began recruiting on May 10th, 2021, is still looking for patients. Last updated on September 22nd, the study needs 160 participants from 24 different medical sites."
Answered by AI
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