Phase 2 N=42 Randomized Quadruple-blind Treatment

A Study of Nalbuphine (Extended Release) ER in Idiopathic Pulmonary Fibrosis (IPF) for Treatment of Cough

Idiopathic Pulmonary Fibrosis

Bottom Line

View on ClinicalTrials.gov: NCT04030026 ↗

Enrolled (actual)

Serious AEs

2.6%

Results posted

May 2025

Primary outcome: Primary: Number of Participants Who Experienced at Least One Treatment Emergent Adverse Events (TEAEs) — 35; 26 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: NAL ER (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Trevi Therapeutics
Primary completion: May 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Who Experienced at Least One Treatment Emergent Adverse Events (TEAEs)	35; 26	—
PRIMARY Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters	0; 0; 1; 0; 1; 1	—
PRIMARY Number of Participants With Clinically Significant Changes in Vital Sign Parameters	0; 0	—
PRIMARY Number of Participants With Clinically Significant Changes in Physical Examination Parameters	0; 0	—
PRIMARY Number of Participants With Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECG)	1; 1	—
PRIMARY Change From Baseline in Forced Vital Capacity (FVC) at Day 21	-2.3; -1.0	—
PRIMARY Subjective Opiate Withdrawal (SOWS) Total Raw Score	4.7055; 2.4082	—
PRIMARY Daytime Cough Frequency at Baseline	27.99; 27.99	—
PRIMARY Percent Change From Baseline in Daytime Cough Frequency at Day 22	-75.11; -22.62	< 0.0001 sig
SECONDARY Change From Baseline in Daytime Cough Frequency at Day 22	-19.386; -6.264	—
SECONDARY Percent Change From Baseline in 24-Hour Cough Frequency at Day 22	-76.10; -25.29	<0.0001 sig
SECONDARY Percent Change From Baseline in Nighttime Cough Frequency at Day 22	-62.27; -20.30	0.0087 sig
SECONDARY Mean Change From Baseline in the Evaluating Respiratory Symptoms (E-RS) Diary Cough Subscale at Days 9, 16, and 22	-0.7; -0.1; -0.9; -0.2; -1.0; -0.2	0.0014 sig
SECONDARY Mean Change From Baseline in E-RS Breathlessness Score at Days 9, 16, and 22	-0.5; 1.1; 0.0; 1.2; 0.1; 0.8	0.0198 sig
SECONDARY Mean Change From Baseline in the Cough Severity Numerical Rating Scale (NRS) at Days 8, 15, and 21	-1.7; -0.4; -2.7; -0.6; -2.5; -0.3	0.0054 sig
SECONDARY Mean Change From Baseline in the 14-item EXAcerbation of Chronic Pulmonary Disease Tool (EXACT) v1.1 e-Diary Tool Total Score at Days 9, 16, and 22	-2.0; 1.6; -1.8; 1.9; -1.6; 0.6	0.0107 sig
SECONDARY Mean Change From Baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) Item Bank v1.0 Fatigue Short Form 7a Scale Total Score at Day 21	0.9; 0.0	0.3601
SECONDARY Clinical Global Impression of Change (CGI-C) Over Time Measured at Day 21	3.0; 3.9	—

Summary

To evaluate the safety and tolerability of nalbuphine ER tablets in the study population and to evaluate the effect of NAL ER tablets on the mean daytime cough frequency (coughs per hour) at Day 22 (dose 162 mg BID) as compared to placebo tablets.

Eligibility Criteria

Inclusion Criteria

Individuals diagnosed with Idiopathic Pulmonary Fibrosis
Chronic cough > 8 weeks.
Daytime cough severity score ≥ 4 on Cough Severity Numerical Rating Scale at screening.

Exclusion Criteria

The following conditions are excluded:
Interstitial lung disease (ILD) known to be caused by domestic and occupational environmental exposures.
Interstitial lung disease (ILD) known to be caused by connective tissue disease.
Interstitial lung disease (ILD) known to be caused by drug related toxicity.
Currently on continuous oxygen therapy.
History of substance abuse that, as determined by the Investigator, may interfere with the conduct of the study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04030026). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.