Last updated 24 days ago

Cough Reduction in IPF with Nalbuphine ER

160 patients around the world

Available in Spain, Chile

This is a multi-center randomized, double-blind, placebo-controlled, parallel, 4-arm study. After meeting eligibility during the Screening Period, subjects will be randomized (1:1:1:1) to one of four treatment arms. - Arm 1: Placebo - Arm 2: 27 mg nalbuphine ER - Arm 3: 54 mg nalbuphine ER - Arm 4: 108 mg nalbuphine ER Each arm will be titrated to their fixed dose during the blinded 2-week Titration period according to Table: Dosing Scheme, followed by the 4-week Fixed Dose Period for a total of 6 weeks on drug. Subjects will be taken off study drug at the end of the Fixed Dose Period and followed off treatment for an additional 2 weeks.

Trevi Therapeutics

5Research sites

160Patients around the world

This study is for people with

Pulmonary fibrosis

Idiopathic pulmonary fibrosis

Requirements for the patient

From 18 Years

All Gender

Medical requirements

: 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.

: 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 subject's ability to successfully complete the study.
Pregnant or lactating female subject.
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.

Sites

Centro de Investigación del Maule - Talca

9 1/2 Oriente #1457. Talca

Hospital Clínico Regional de Concepción Dr. Guillermo Grant Benavente - Concepción, Chile

San Martín 1436, Concepción, Bío Bío

Clínica Universidad de los Andes

Av Plaza 2501, Las Condes, Región Metropolitana, Santiago

Hospital Carlos van Buren

Valparaíso, Región De Valparaíso

Oncocentro APYS - Valparaíso

Avenida La Marina 1702, Viña del Mar, Valparaíso

StudyCORAL

SponsorTrevi Therapeutics

Conditions

Idiopathic pulmonary fibrosis

Requirements

From 18 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT05964335