A randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of 2 doses of inhaled pirfenidone (AP01) versus placebo on top of standard of care in participants with PPF over 52 weeks.
This is a randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of 2 doses of AP01 (pirfenidone solution for inhalation) versus placebo on top of standard of care in participants with PPF over 52 weeks. Up to 300 eligible participants will be randomized to 1 of 3 treatment arms: AP01 high dose, AP01 low dose, or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
375
University of Alabama at Birmingham
Birmingham, Alabama, United States
RECRUITINGMayo Clinic- Scottsdale
Scottsdale, Arizona, United States
RECRUITINGUniversity of Southern California
Los Angeles, California, United States
RECRUITINGCedars-Sinai
Los Angeles, California, United States
To evaluate the effect of AP01 high dose twice a day (BID) or AP01 low dose twice a day (BID) compared to placebo twice a day (BID)
Change from baseline in forced vital capacity (FVC) (mL)
Time frame: Week 52
To evaluate the effect of AP01 high dose and AP01 low dose compared to placebo on disease progression (defined as absolute FVC percent predicted decline of ≥10% prior to Week 52)
Time to disease progression
Time frame: 52 weeks
To evaluate the effect of AP01 high dose, AP01 low dose compared to placebo on quality of life (QoL)
Absolute change from Baseline in QoL measurements as assessed by Living with Pulmonary Fibrosis Symptoms and Impact Questionnaire (L-PF) total score. The L-PF is a 44-item questionnaire to assess how impacted a participant is by disease symptoms on a scale from 0 (Not at all) to 4 (Extremely). The higher the summary score, the greater the impairment.
Time frame: 52 weeks
To evaluate the change from baseline in quantitative lung fibrosis score.
Change in lung fibrosis score.
Time frame: 52 weeks
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UCLA
Los Angeles, California, United States
RECRUITINGNewport Native MD, Inc.
Newport Beach, California, United States
RECRUITINGParadigm Clinical Research - Redding
Redding, California, United States
RECRUITINGUniversity of California - San Francisco
San Francisco, California, United States
RECRUITINGUniversity of Colorado, Anschutz Medical Campus
Aurora, Colorado, United States
RECRUITINGNational Jewish Health
Denver, Colorado, United States
RECRUITING...and 142 more locations