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This study will evaluate the impact Nintedanib Solution for Inhalation (AP02) has on lung function and key measures of fibrosis in adult patients with idiopathic pulmonary fibrosis (IPF) as well as assess its safety and tolerability.
Adults 40 years of age or older with IPF who meet the inclusion and exclusion criteria can participate in this study if they are not currently on treatment for IPF, and if treated with oral nintedanib or pirfenidone, have stopped the medication for at least 3 months.
Researchers will compare two different doses of AP02 to a placebo (a look-alike substance that contains no drug) to see if AP02 works to treat IPF. Participants are put into 1 of 3 groups randomly, which means by chance and will take AP02 or a placebo two times every day for 12 weeks by using a nebulizer, which is a device that provides medicine to the lungs via inhalation.
Participants will visit the office 6 times and receive 1 phone call over a 16-week period. At site visits doctors regularly perform breathing tests that measure how well the lungs are working, give the patient questionnaires and will check the participants' health.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo BID | Placebo Comparator | Placebo solution for Inhalation |
|
| AP02 low dose BID | Active Comparator | Nintedanib solution for Inhalation |
|
| AP02 high dose BID | Active Comparator | Nintedanib solution for Inhalation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AP02 | Drug | Oral inhalation solution |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the morning pre-dose forced vital capacity at Week 12 | From enrollment to the end of treatment at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to disease progression | Disease progression is defined as forced vital capacity (FVC) percent predicted decline of ≥10% prior to Week 12, respiratory hospitalization, or death. | From enrollment to the end of treatment at 12 weeks |
| To evaluate the change from baseline in quantitative lung fibrosis score |
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Inclusion Criteria:
Exclusion Criteria:
Further inclusion/exclusion criteria apply
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Craig S Conoscenti, MD, FCCP, ATSF | Contact | 206-707-0340 | AP02-003regulatory@avalynpharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nepean Lung and Sleep | Recruiting | Kingswood | New South Wales | 2747 | Australia | |
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| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Placebo |
| Drug |
Placebo oral inhalation solution |
|
Change in lung fibrosis score. |
| From enrollment to the end of treatment at 12 weeks |
| Dynamic Drug Advancement |
| Recruiting |
| Ajax |
| Ontario |
| L1S2J5 |
| Canada |
| CIC Mauricie | Active, not recruiting | Trois-Rivières | Quebec | G8T 7A1 | Canada |