Now Enrolling: 

The MIST Study

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

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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
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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.

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

Pirfenidone Solution for Inhalation (AP01): the investigative medicine in this study

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AP01 is an investigational drug device combination and is not approved by any health authority