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A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-04-03
Primary completion: 2026-04-01
Study completion finish: 2026-04-01
Study type
TREATMENT
Phase
PHASE2
Trial ID
NCT06329401
Intervention or treatment
DRUG: AP01
OTHER: Placebo
Conditions
- • Progressive Pulmonary Fibrosis
Find a site
Closest Location:
Westmead Hospital
Research sites nearby
Select from list below to view details:
Westmead Hospital
Westmead, New South Wales, Australia
Macquarie University Clinical Trials Unit
Sydney, New South Wales, Australia
Institute for Respiratory Health
Nedlands, Perth West Australia, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: AP01 High Dose BID
| DRUG: AP01
|
EXPERIMENTAL: AP01 Low Dose BID
| DRUG: AP01
|
PLACEBO_COMPARATOR: Placebo BID
| OTHER: Placebo
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
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) | Week 52 |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
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. | 52 weeks |
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 | 52 weeks |
To evaluate the change from baseline in quantitative lung fibrosis score. | Change in lung fibrosis score. | 52 weeks |
Frequently Asked Questions
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