Clinical trial participants are essential in the quest for new treatments and a cure for pulmonary fibrosis (PF).

Each month in this newsletter, we'll highlight a few of the many trials that are enrolling volunteers. To view more available trials for various forms of interstitial lung disease (ILD), please visit the 🔍 PFF Clinical Trial Finder.

Seeking participants with IPF

ASPIRE

• Study ID: NCT06588686
• Trial Phase: Phase 2
• Intervention: Oral drug
• Sponsor: Vicore Pharma AB
• Study Contact: Thomas Eskildsen, MSc., Pharm. and Bernt Van Den Blink, MD (+46.3.17.880.560; info@aspire-ipf.com)
• Learn more about this study
• Learn more about this drug

Seeking participants with IPF or PPF

A Study to Test Whether BI 1839100 Improves Cough in People With Idiopathic Pulmonary Fibrosis or Progressive Pulmonary Fibrosis

• Study ID: NCT06360094
• Trial Phase: Phase 2
• Intervention: Oral drug
• Sponsor: Boehringer Ingelheim
• Study Contact: 800.243.0127; clintriage.rdg@boehringer-ingelheim.com 
• Learn more about this study
• Learn more about this drug

Seeking participants for the PFF Community Registry

PFF Community Registry

• Study ID: NCT05382572
• Intervention: Observational
• Sponsor: Pulmonary Fibrosis Foundation
• Study Contact: Jessica E Shore, PhD (312.818.5731; registry@pulmonaryfibrosis.org)
• Learn more about this study

For years, doctors told Bonnie that her cough was a result of chronic bronchitis, but no treatments seemed to help. When the cough became so violent that it caused her to vomit, she knew something was very wrong.

After tests confirmed Bonnie’s PF diagnosis, her resourceful and resilient nature prompted her to research the disease and find quality medical care. Today, Bonnie stays active by walking her dogs, participating in support groups, reading the latest information on PF, and using her voice as a PFF Ambassador to encourage patients, caregivers, and physicians to educate themselves about the disease.

 Clinical trial participation is another way you can get involved. To learn more about clinical trials and research studies, visit our Clinical Trials Education Center.

 

Multiple research programs presented on at ATS 2025

In May, PFF staff attended the American Thoracic Society (ATS) 2025 Conference. This international conference brings together healthcare providers, researchers, drug developers, and patient advocates to learn about the latest developments in pulmonary research. Here, Avalyn Pharma presented clinical data on two potential inhaled medicines for PF.

Inhaled nintedanib (AP02) was evaluated in a phase 1 study of 60 healthy participants and in a phase 1a study of patients living with IPF. Researchers use phase 1 studies to test a new drug or treatment in a small group of people to evaluate its safety, determine a safe dosage range, and identify side effects. In these studies, Avalyn demonstrated inhaled nintedanib to be both safe and well tolerated. Next, the company plans to move forward with a phase 2 study. In a phase 2 study the medication is administered to a larger group of people to evaluate how well the medication works and further assess the safety. 

Inhaled pirfenidone (AP01) was evaluated in an open-label extension study of 100 participants diagnosed with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). In an open-label extension, patients who previously participated in a clinical trial are given the opportunity to receive the medication being studied and these patients are then followed by researchers to collect more data on the safety, tolerability, and efficacy of the medication. Avalyn’s open-label extension demonstrates ongoing safety, efficacy and tolerability in patients 240 weeks after starting the medication. Inhaled pirfenidone continues to be evaluated in Avalyn’s phase 2 PPF study.

With patients potentially struggling with the side effects of current treatments, these new inhaled options may be a key step towards improving the quality of life for those living with PF.

Phase 2b chronic cough in IPF trial shows positive results

Last month, Trevi Therapeutics announced positive results for its phase 2b study, CORAL. The clinical trial studied the safety and efficacy of the oral drug, nalbuphine ER (Haduvio™), for the treatment of chronic cough in patients living with IPF.

The CORAL trial met its primary endpoint, reducing the frequency of the number of participants’ coughs per hour. Endpoints are targeted outcomes of clinical trials statistically analyzed to determine how safe and effective the potential treatment is. Trevi plans to initiate the next phase of this program, a phase 3 study, in the first half of 2026.

Currently there are no approved therapies for chronic cough among patients with IPF. This clinical trial update is an important step forward for people living with IPF and their unmet needs in relation to cough.

Watch the June PFF CTI Webinar Series

The PFF hosted its second webinar in the PFF CTI Webinar Series on Wednesday, June 4, 2025. You can now watch the recording to hear from people leading the trials featured in this month’s clinical trials newsletter.

Watch the June PFF CTI Webinar now.

If you have any questions or comments about this newsletter, please email partnerships@pulmonaryfibrosis.org.