Status:
COMPLETED
Cough Reduction in IPF With Nalbuphine ER
Lead Sponsor:
Trevi Therapeutics
Conditions:
Idiopathic Pulmonary Fibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The main purpose of the study is to evaluate the effect of NAL ER on 24-hour cough frequency using objective digital cough monitoring and to assess safety and tolerability of NAL ER.
Eligibility Criteria
Inclusion
- Diagnosis of IPF as determined by the Principal 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 - Forced Vital Capacity, as determined by spirometry adhering to ATS/ERS guidelines.
- DLCO ≥ 25% predicted of normal - Diffusing capacity of the lung for carbon monoxide corrected for hemoglobin, assessed within the last 12 weeks, or at the time of screening.
Exclusion
- 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.
- Inadequate swallow reflex as assessed by the ability to sip 3 fluid oz (or 89 mL) of water without coughing or choking.
- Upper or lower respiratory tract infection in the last 8 weeks prior to the baseline visit.
- Clinical history of aspiration pneumonitis.
- Diagnosis of sleep apnea.
- Abnormal kidney or liver functions based on Screening lab results.
- Known hypersensitivity to nalbuphine or to NAL ER excipients
- History of major psychiatric disorder.
- History of substance abuse.
- Significant medical condition or other factors that may interfere with the participant's ability to successfully complete the study.
- Pregnant or lactating female participant.
- Known intolerance (gastrointestinal, central nervous system symptoms), hypersensitivity, drug allergy following the use of an opioid drug.
- Use of opiates is prohibited within 14 days prior to the baseline visit.
- Use of benzodiazepines are prohibited within 14 days prior to the baseline visit and for the duration of the study.
- 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 cough treatment is prohibited within 4 weeks prior to the baseline visit and for the duration of the study.
- 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.
- Use of a medication having a "known risk" of Torsade de Pointes (categorized as "KR" on the Credible Meds® website.) 4 weeks prior to Baseline.
- Use of unstable doses of medications associated with a potential risk of QT prolongation but not clearly associated with Torsade de Pointes within 4 weeks of screening.
- Other protocol defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
February 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 24 2025
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT05964335
Start Date
February 6 2024
End Date
April 24 2025
Last Update
June 27 2025
Active Locations (59)
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1
Eastern Health-Box Hill Hospital
Box Hill, Australia, 3128
2
Concord Repatriation General Hospital
Concord, Australia, 2139
3
Austin Hospital
Heidelberg, Australia, 3084
4
Respiratory Clinical Trials Pty Ltd
Kent Town, Australia, 5067