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The MIST Study

A Phase 2b study for people living with Progressive Pulmonary Fibrosis (PPF)

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About the MIST Study

This is a Phase 2b study, or clinical trial, for people living with PPF. The goal of the MIST Study is to learn more about the investigational study medicine: an inhaled version of pirfenidone called AP01.

What is PPF?

Progressive Pulmonary Fibrosis (PPF) is a rare lung disease that causes lung scarring. This makes it hard to breathe.

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What to Expect

52 weeks long (or more for participants who choose to continue on an extension study)

The study medicine or a placebo will be inhaled by nebulizer twice a day

Medical exams and tests at most appointments

Study exams, tests and treatments are provided at no charge to participants

Frequent appointments with study doctors

Many study sites across the U.S.

Who Can Join the MIST Study?

Adults ages 18 and over diagnosed with PPF (not Idiopathic Pulmonary Fibrosis)
Meets spirometry test requirements
Able to meet other study requirements explained by the study doctor

Why a Placebo?

Some study participants will be randomly selected to take a placebo. A placebo is a substance that looks like the study medicine but has no active ingredients. Study participants and staff will not know who is taking the placebo. This is done to prevent bias and to understand if the investigative medicine is working.

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Why Join This Clinical Study?

Joining a study is an important, personal decision. There are many reasons to consider joining:

Researchers want to know if an inhaled form of pirfenidone (AP01) may improve lung function and have fewer side effects. There is no cure for PPF. Current treatments in pill form can slow the disease in some people. However, high doses are needed for the swallowed medicine to reach the lungs, which may cause side effects.
By volunteering to join a study, you can help researchers learn more about PPF. Clinical research studies are how new treatments are developed.

What is Informed Consent?

With any clinical research study there are benefits and risks to participation. The study team will explain them to you as part of informed consent.
If you have any questions about the informed consent process, the study, the study medicine, or any of the study requirements, ask the study team so you can make a confident decision.
You do not have to join the study, and you may discontinue your involvement at any time.

What Happens After the Study?

All study participants who complete this study will have the chance to join an ongoing extension study to take the investigative medicine (not the placebo) at no charge.

The MIST Study: What the Official Study Title Means

A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study Evaluating the Safety and Efficacy of Pirfenidone Solution for Inhalation (AP01) in People with Progressive Pulmonary Fibrosis (PPF)

Randomized: to ensure there is no bias or unfairness in the study results, study participants are assigned by chance to receive the investigative medicine or placebo

Double-Blind: to prevent bias, no one in the study (patients) and no one running the study (doctors or nurses) will know if the study participant is taking the investigative medicine or placebo until after the study is finished

Placebo: A placebo is made to look like the investigative medicine, but it is not meant to affect health

Placebo-controlled: a type of study that has one group of study participants who take the investigative medicine with active ingredients, and another group that gets the placebo, which has no active ingredients

Phase 2b: a study that is researching the safety, effectiveness, and dosage of the investigative medicine

Efficacy: researchers want to know if an investigative medicine works the way it was intended

Safety: this study will be monitored by the study doctor, study sponsor, and independent experts to monitor the safety of the investigative medicine