BridgeMD
A Randomized, Double-Blind, Placebo-Controlled, Parallel, 4-Arm Dose Ranging Study of the Safety and Efficacy of Nalbuphine Extended-Release Tablets (NAL ER) for the Treatment of Cough in Idiopathic Pulmonary Fibrosis (IPF)
EU CTIS ID: 2023-505296-72-00
What this study is testing
Effect of NAL ER on 24-hour cough frequency (coughs per hour) at Week 6 using objective digital cough monitoring.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Diagnosis of IPF as determined by the Investigator based on ATS/ERS/JRS/ALAT guidelines.
- Cough Severity Score ≥ 4 on CS-NRS (Cough Severity Numerical Rating Scale) during the Screening period and Baseline.
- History of chronic cough for at least 8 weeks before screening.
- SpO2 ≥ 92%, taken after at least 5 minutes in a sitting position, undisturbed and non-stimulated (Saturation of Hemoglobin with Oxygen as Measured by Pulse Oximetry).
- FVC ≥ 40% predicted of normal – Force Vital Capacity, as determined by spirometry adhering to ATS/ERS guidelines.
- DLCO ≥ 25% predicted of normal - Diffusing capacity of the lungs for carbon monoxide corrected for hemoglobin, assessed within the last 12 weeks, or at the time of screening.
You likely can't join if
- Currently on continuous oxygen therapy for longer than 16 hours at any level or delivered by any modality. Intermittent oxygen use of any duration over any given 24-hour period is allowed.
- Monoamine oxidase inhibitors (MAOIs) including methylene blue (methylthioninium chloride) and the antibiotic linezolid are prohibited within 14 days prior to the baseline visit and for the duration of the study.
- Use of oral corticosteroid prescribed as cough treatment is prohibited within 4 weeks prior to the baseline visit and for the duration of the study.
- Inadequate swallow reflex as assessed by the ability to sip 3 fluid oz (or 90 mL) of water without coughing or choking.
- Exposure to any investigational medication, including placebo, is prohibited within 4 weeks prior to the baseline visit and for the duration of the study.
- Medications prescribed as cough suppressants are prohibited unless on a stable dose 14-days prior to the baseline visit and are expected to remain on that dose for the duration of the study.
See the full eligibility criteria
Who can join
- Diagnosis of IPF as determined by the Investigator based on ATS/ERS/JRS/ALAT guidelines.
- Cough Severity Score ≥ 4 on CS-NRS (Cough Severity Numerical Rating Scale) during the Screening period and Baseline.
- History of chronic cough for at least 8 weeks before screening.
- SpO2 ≥ 92%, taken after at least 5 minutes in a sitting position, undisturbed and non-stimulated (Saturation of Hemoglobin with Oxygen as Measured by Pulse Oximetry).
- FVC ≥ 40% predicted of normal – Force Vital Capacity, as determined by spirometry adhering to ATS/ERS guidelines.
- DLCO ≥ 25% predicted of normal - Diffusing capacity of the lungs for carbon monoxide corrected for hemoglobin, assessed within the last 12 weeks, or at the time of screening.
- Males or females ages 18 years and older at the time of consent.
- Willing and able to provide written informed consent, comply with study requirements and restrictions, and agree to the confidential use and storage of all data and use of all anonymized data for publication including scientific publication.
What rules you out
- Currently on continuous oxygen therapy for longer than 16 hours at any level or delivered by any modality. Intermittent oxygen use of any duration over any given 24-hour period is allowed.
- Monoamine oxidase inhibitors (MAOIs) including methylene blue (methylthioninium chloride) and the antibiotic linezolid are prohibited within 14 days prior to the baseline visit and for the duration of the study.
- Use of oral corticosteroid prescribed as cough treatment is prohibited within 4 weeks prior to the baseline visit and for the duration of the study.
- Inadequate swallow reflex as assessed by the ability to sip 3 fluid oz (or 90 mL) of water without coughing or choking.
- Exposure to any investigational medication, including placebo, is prohibited within 4 weeks prior to the baseline visit and for the duration of the study.
- Medications prescribed as cough suppressants are prohibited unless on a stable dose 14-days prior to the baseline visit and are expected to remain on that dose for the duration of the study.
- Use of medications that affect serotonergic neurotransmission and that when used concomitantly with opioids can increase the risk of serotonin syndrome are prohibited unless on a stable dose 14-days prior to the baseline visit and are expected to remain on that dose for the duration of the study.
- Anti-fibrotic medications are prohibited unless on a stable dose for 8 weeks prior to the baseline visit and are expected to remain on that dose for the duration of the study.
- Strong inhibitors/inducers of the P450 Isozymes are prohibited unless on a stable dose for 14-days prior to baseline visit and are expected to remain on that dose for the duration of the study.
- Upper or lower respiratory tract infection in the last 8 weeks prior to the baseline visit.
- Clinical history of aspiration pneumonitis.
- History of major psychiatric disorder, which in the opinion of the Investigator, could interfere with the assessment of anti-cough efficacy and/or safety events during the study or with the ability of the subject to cooperate with study requirements.
- Diagnosis of sleep apnea.
- Cardiac Safety: Mean QTcF value of 3 centrally read screening electrocardiograms (ECGs) calculated as: a) ≥470ms if QRS <120ms or b) ≥500ms in the presence of either a Right Bundle Branch Block (RBBB) or QRS ≥120ms.
- Heart Rate: <50 bpm or >100 bpm, as determined by vital signs pulse over 30-60 seconds. a) Subjects with a resting heart rate of <50 bpm will have it repeated once after 5 minutes in the supine position, and if it remains <50 bpm during the repeat, they will be considered a screen failure. b) Subjects with a rate >100 bpm should be considered a screen failure. Rescreening may be possible with the approval of the medical monitor, after medical or alternative management of the atrial fibrillation.
- Kidney Function: Estimated glomerular filtration rate ≤44 mL/min/1.73 m2 at screening.
- Liver Function: Total Bilirubin >3mg/dL [>50umol/L] and Serum Albumin <2.8g/dL at screening.
- Known hypersensitivity to nalbuphine or to NAL ER excipients.
- Use of a medication having a “known risk” of Torsade de Pointes (TdP) categorized as “KR” on the Credible Meds® website, is prohibited within 4 weeks prior to the baseline visit and for the duration of the study. Medications associated with a potential risk of QT prolongation, but not clearly associated with TdP, are permitted at study entry if the following criteria are met: • Subject has been given medication at stable doses for a full 4 weeks prior to baseline. • Medication dose will not be increased after baseline, or during the study, and it is anticipated that the subject will receive the medication for the entirety of the study.
- History of substance abuse, including excessive alcohol consumption, that in the opinion of the investigator, may interfere with the conduct of the study. Alcohol consumption should be limited for the duration of study treatment.
- Significant medical condition or other factors as assessed by the investigator that may interfere with the subject’s ability to successfully complete the study.
- Pregnant or lactating female subject. Women of childbearing potential (WOCBP) must use an acceptable method of birth control and have a negative pregnancy test at the screening and baseline visits. WOCBP and acceptable methods of birth control are defined in the protocol.
- Known intolerance (gastrointestinal, central nervous system symptoms), hypersensitivity, drug allergy following the use of an opioid drug.
- Concurrent or anticipated enrollment in an ongoing interventional clinical trial. Observational or long-term safety follow-up studies (e.g., in a vaccine study) may be allowed upon medical monitor approval.
- Use of opiates is prohibited within 14 days prior to the baseline visit. This includes opiate containing anti-cough agents, and naltrexone. Subjects are prohibited from using opioids for the duration of the study.
- Use of benzodiazepines are prohibited within 14 days prior to the baseline visit and for the duration of the study.
The study team makes the final eligibility decision.
Where it's taking place
- Chile
- Australia
- United Kingdom
- Korea, Democratic People's Republic of
- Turkey
- Canada
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 - 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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chile; Australia; United Kingdom; Korea, Democratic People's Republic of; Turkey; Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.