Idiopathic Pulmonary Fibrosis study: NAL ER
Official title Idiopathic Pulmonary Fibrosis (IPF)-Related Chronic Cough Reduction With Nalbuphine Extended-Release (NAL ER) Tablets
ClinicalTrials.gov ID: NCT07671911
What this study is testing
What is NAL ER?
NAL ER is an investigational medicine, taken by mouth, being studied as a potential treatment for idiopathic pulmonary fibrosis.
Also referred to as Nalbuphine.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will find out if nalbuphine extended‑release is safe and can lessen chronic cough in patients with idiopathic pulmonary fibrosis.
- Who it's for
- Adults who have idiopathic pulmonary fibrosis and a persistent cough.
- What's involved
- Participants will take nalbuphine extended‑release tablets and undergo safety checks and cough assessments during study visits.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- Diagnosis of IPF as determined by the Investigator based on American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory...
- Chronic cough for ≥8 weeks prior to Screening.
- PGI-Severity Score ≥ 2 at Screening.
- Forced vital capacity (FVC) ≥40 percent (%) of predicted at Screening.
- Diffusing capacity for carbon monoxide (DLCO) ≥25% of predicted during Screening or within 12 weeks prior to Screening.
You likely can't join if
- Clinical diagnosis or clinical suspicion of an upper or lower respiratory tract infection in the last 8 weeks prior to the Screening visit or during...
- Hospitalization for any respiratory illness (including acute exacerbation of IPF) within 2 months prior to Screening.
See the full eligibility criteria
- Diagnosis of IPF as determined by the Investigator based on American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Society (ALAT) clinical practice...
- Chronic cough for ≥8 weeks prior to Screening.
- PGI-Severity Score ≥ 2 at Screening.
- Forced vital capacity (FVC) ≥40 percent (%) of predicted at Screening.
- Diffusing capacity for carbon monoxide (DLCO) ≥25% of predicted during Screening or within 12 weeks prior to Screening.
- Participants who are currently taking antifibrotic medication (nintedanib, pirfenidone, nerandomilast) approved for IPF should be on a stable dose for at least 6 weeks prior to the Baseline Visit.
- Clinical diagnosis or clinical suspicion of an upper or lower respiratory tract infection in the last 8 weeks prior to the Screening visit or during Screening.
- Hospitalization for any respiratory illness (including acute exacerbation of IPF) within 2 months prior to Screening. Note: Other protocol-defined inclusion/exclusion criteria may apply.
The study team makes the final eligibility decision.
Where it is enrolling
- Newport Beach, California, United States
- Palm Springs, California, United States
- Redding, California, United States
- Lakewood, Colorado, United States
- Brandon, Florida, United States
- Kissimmee, Florida, United States
- Loxahatchee Groves, Florida, United States
- Miami, Florida, United States
- St. Petersburg, Florida, United States
- New Orleans, Louisiana, United States
- Hannibal, Missouri, United States
- Reno, Nevada, United States
- The Bronx, New York, United States
- Gastonia, North Carolina, United States
- Winston-Salem, North Carolina, United States
- DuBois, Pennsylvania, United States
- Anderson, South Carolina, United States
- Cypress, Texas, United States
- El Paso, Texas, United States
- Houston, Texas, United States
+ 2 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Newport Beach, California, United States; Palm Springs, California, United States; Redding, California, United States; Lakewood, Colorado, United States; Brandon, Florida, United States; Kissimmee, Florida, United States and 16 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.