Idiopathic Pulmonary Fibrosis study: NAL ER
Official title Idiopathic Pulmonary Fibrosis (IPF)-Related Chronic Cough Reduction With Nalbuphine (NAL) Extended-Release (ER) Tablets
ClinicalTrials.gov ID: NCT07868419
What this study is testing
What is NAL ER?
This is an investigational oral tablet being studied to see if it can help with chronic cough in people with idiopathic pulmonary fibrosis. It is designed to block certain opioid receptors in the body to help reduce the urge to cough.
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
- This study aims to find out if nalbuphine is safe and effective for treating chronic cough in people with idiopathic pulmonary fibrosis (IPF).
- Who it's for
- People who have idiopathic pulmonary fibrosis (IPF) and suffer from chronic cough.
- What's involved
- Participants will take nalbuphine extended-release tablets and undergo tests to check for side effects and cough improvement.
- Time commitment
- The source text does not specify the duration or visit schedule for this study.
- 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 8 weeks 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.
- If currently taking antifibrotic medication (nintedanib, pirfenidone, nerandomilast) 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 8 weeks prior to Screening. Note: Other protocol-defined inclusion/exclusion criteria may apply.
The study team makes the final eligibility decision.
Where it is enrolling
- Wilmington, Delaware, United States
- North Miami Beach, Florida, United States
- Charlotte, North Carolina, United States
- Sugar Land, Texas, United States
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 Wilmington, Delaware, United States; North Miami Beach, Florida, United States; Charlotte, North Carolina, United States; Sugar Land, Texas, United States. 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.