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Opioid Analgesic

Nalbuphine ER for Pulmonary Fibrosis (CORAL Trial)

Phase 2
Recruiting
Research Sponsored by Trevi Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of IPF as determined by the Principal Investigator based on ATS/ERS/JRS/ALAT guidelines
FVC ≥ 40% predicted of normal - Forced Vital Capacity, as determined by spirometry adhering to ATS/ERS guidelines
Must not have
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
Diagnosis of sleep apnea
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 1, 2, 3, 4, 5, 6

Summary

This trial is testing a drug called nalbuphine ER in different doses to see its effect on participants. Participants will be randomly assigned to one of four groups: one will receive a placebo,

Who is the study for?
This trial is for adults with Idiopathic Pulmonary Fibrosis (IPF) who have a chronic cough and meet specific lung function criteria, including a Cough Severity Score of at least 4, oxygen saturation levels above 92%, and certain capacities in diffusing carbon monoxide and forced vital capacity. It's not suitable for those who don't meet these lung function thresholds.
What is being tested?
The study tests the effectiveness of three different doses of nalbuphine ER (27 mg, 54 mg, and 108 mg) compared to a placebo in reducing cough due to IPF. Participants are randomly assigned to one of four groups and will take their assigned treatment over six weeks after an initial titration period.
What are the potential side effects?
While the side effects aren't specified here, nalbuphine ER may cause dizziness, nausea, dry mouth or sweating. Side effects can vary based on dosage; higher doses typically increase the likelihood of experiencing them.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with IPF by a specialist.
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My lung function test shows at least 40% of normal capacity.
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My cough is severe, scoring 4 or more on a scale.
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I have had a chronic cough for at least 8 weeks.
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My lung's ability to transfer gas is at least 25% of what is expected.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I use oxygen therapy for more than 16 hours a day.
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I have been diagnosed with sleep apnea.
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I haven't taken any MAOIs or certain antibiotics in the last 14 days.
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I haven't taken oral corticosteroid cough medicine in the last 4 weeks.
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I haven't taken any medication known to increase the risk of a specific heart rhythm problem in the last 4 weeks.
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My kidney or liver tests are not normal.
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I have had lung inflammation from inhaling food or liquid.
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I haven't taken any benzodiazepines in the last 14 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 1, 2, 3, 4, 5, 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 1, 2, 3, 4, 5, 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Effect of NAL ER on 24-hour cough frequency (coughs per hour)
Secondary study objectives
24-hour cough frequency (Coughs per hour)
Awake cough frequency (Coughs per hour)
CGI-C
+14 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: NAL ER 54 mgExperimental Treatment1 Intervention
BID
Group II: NAL ER 27 mgExperimental Treatment1 Intervention
BID
Group III: NAL ER 108 mgExperimental Treatment1 Intervention
BID
Group IV: PlaceboPlacebo Group1 Intervention
Placebo, tablets BID

Find a Location

Who is running the clinical trial?

Trevi TherapeuticsLead Sponsor
10 Previous Clinical Trials
1,227 Total Patients Enrolled
1 Trials studying Idiopathic Pulmonary Fibrosis
42 Patients Enrolled for Idiopathic Pulmonary Fibrosis
Chief Development OfficerStudy DirectorTrevi Therapeutics
3 Previous Clinical Trials
384 Total Patients Enrolled
David Clark, MDStudy DirectorTrevi Therapeutics
4 Previous Clinical Trials
520 Total Patients Enrolled
~49 spots leftby Apr 2025
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