Ignite Creation Date:
2025-12-24 @ 10:15 PM
Ignite Modification Date:
2025-12-25 @ 7:49 PM
Study NCT ID:
NCT05964335
Status:
COMPLETED
Last Update Posted:
2025-06-27
First Post:
2023-07-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cough Reduction in IPF With Nalbuphine ER
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054990', 'term': 'Idiopathic Pulmonary Fibrosis'}, {'id': 'D003371', 'term': 'Cough'}], 'ancestors': [{'id': 'D011658', 'term': 'Pulmonary Fibrosis'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009266', 'term': 'Nalbuphine'}], 'ancestors': [{'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 165}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-04-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-23', 'studyFirstSubmitDate': '2023-07-07', 'studyFirstSubmitQcDate': '2023-07-19', 'lastUpdatePostDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relative Change From Baseline in 24-hour Cough Frequency at Week 6', 'timeFrame': 'Baseline, Week 6'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Evaluating Respiratory Symptoms in Idiopathic Pulmonary Fibrosis (E-RS:IPF) Cough subscale at Week 6', 'timeFrame': 'Baseline, Week 6'}, {'measure': 'Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs)', 'timeFrame': 'Up to Week 12'}, {'measure': 'Relative Change From Baseline in 24-hour Cough Frequency at Weeks 2,4, and 6', 'timeFrame': 'Baseline, Weeks 2, 4, and 6'}, {'measure': 'Percentage of Responders With ≥30%, ≥50% and ≥75% Reduction in the 24-Hour Cough Frequency at Week 2, 4, and 6', 'timeFrame': 'At Weeks 2, 4, and 6'}, {'measure': 'Relative Change From Baseline in Awake Cough Frequency at Week 2, 4, and 6', 'timeFrame': 'Baseline, Weeks 2, 4, and 6'}, {'measure': 'Relative Change From Baseline in Sleep Cough Frequency at Week 2, 4, and 6', 'timeFrame': 'Baseline, Weeks 2, 4, and 6'}, {'measure': 'Change From Baseline in E-RS: IPF Cough Subscale at Weeks 1, 2, 3, 4, 5, and 6', 'timeFrame': 'Baseline, Weeks 1, 2, 3, 4, 5, 6'}, {'measure': 'Percentage of E-RS: IPF Cough Subscale Responders With At least one Category Improvement at Weeks 1, 2, 3, 4, 5, and 6', 'timeFrame': 'At Weeks 1, 2, 3, 4, 5, and 6'}, {'measure': 'Change From Baseline in E-RS: IPF Total Score, Subdomain Scores (IPF-Breathlessness, IPF-Cough, IPF-Sputum, and IPF-Chest Symptoms) and Individual Items at Weeks 1, 2, 3, 4, 5, and 6', 'timeFrame': 'Baseline, Weeks 1, 2, 3, 4, 5, and 6'}, {'measure': 'Change From Baseline in Cough Severity Numerical Rating Scale (CS-NRS) at Weeks 1, 2, 3, 4, 5, and 6', 'timeFrame': 'Baseline, Weeks 1, 2, 3, 4, 5, and 6'}, {'measure': 'Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score at Week 6', 'timeFrame': 'Baseline, Week 6'}, {'measure': 'Percentage of LCQ Total Score Responders With 1.3-Point Increase Response at Week 6', 'timeFrame': 'At Week 6'}, {'measure': 'Change From Baseline in LCQ Domains and Individual Items at Week 6', 'timeFrame': 'Baseline, Week 6'}, {'measure': 'Change From Baseline in Living With Pulmonary Fibrosis Impacts Questionnaire (L-IPF©) at Week 6', 'timeFrame': 'Baseline, Week 6'}, {'measure': 'Change From Baseline in Living With Pulmonary Fibrosis Symptoms Questionnaire (L-IPF) and its Domains at Week 6', 'timeFrame': 'Baseline, Week 6'}, {'measure': 'Change from Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L™) at Week 6', 'timeFrame': 'Baseline, Week 6'}, {'measure': 'Change From Baseline in Patient Global Impression of Severity (PGI-S) Cough at Weeks 2, 4, and 6', 'timeFrame': 'Baseline, Weeks 2, 4, and 6'}, {'measure': 'Absolute Values of PGI-C Cough Score at Weeks 2, 4, and 6', 'timeFrame': 'At Weeks 2, 4, and 6'}, {'measure': 'Percentage of Participants With Improvement by ≥1 and ≥2 Categories, Worsening by ≥1 and ≥2 Categories, and no Change on PGI-C and PGI-S Cough at Each Post-Baseline Timepoint', 'timeFrame': 'At Weeks 2, 4, and 6'}, {'measure': 'Change from Baseline in PGI-S IPF at Weeks 2, 4, and 6', 'timeFrame': 'Baseline, Weeks 2, 4, and 6'}, {'measure': 'Absolute Values of PGI-C IPF at Weeks 2, 4, and 6', 'timeFrame': 'At Weeks 2, 4, and 6'}, {'measure': 'Percentage of Participants With Improvement by ≥1 and ≥2 Categories, Worsening by ≥1 and ≥2 Categories, and no Change on the PGI-C and PGI-S IPF at Weeks 2, 4, and 6', 'timeFrame': 'At Weeks 2, 4, and 6'}, {'measure': 'Change From Baseline in Clinicians Global Impression of Severity (CGI-S) score at Week 6', 'timeFrame': 'Baseline, Week 6'}, {'measure': 'Absolute Values for CGI-C IPF Score at Week 6', 'timeFrame': 'At Week 6'}, {'measure': 'Percentage of Participants With Improvement by ≥1 and ≥2 Categories, Worsening by ≥1 and ≥2 Categories, and no Change on the CGI-C and CGI-S at Week 6', 'timeFrame': 'At Week 6'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cough', 'Nalbuphine'], 'conditions': ['Idiopathic Pulmonary Fibrosis']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of IPF as determined by the Principal Investigator based on ATS/ERS/JRS/ALAT guidelines.\n* Cough Severity Score ≥ 4 on CS-NRS (Cough Severity Numerical Rating Scale) during the Screening period and Baseline.\n* History of chronic cough for at least 8 weeks before screening.\n* 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).\n* FVC ≥ 40% predicted of normal - Forced Vital Capacity, as determined by spirometry adhering to ATS/ERS guidelines.\n* 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.\n\nExclusion Criteria:\n\n* 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.\n* Inadequate swallow reflex as assessed by the ability to sip 3 fluid oz (or 89 mL) of water without coughing or choking.\n* Upper or lower respiratory tract infection in the last 8 weeks prior to the baseline visit.\n* Clinical history of aspiration pneumonitis.\n* Diagnosis of sleep apnea.\n* Abnormal kidney or liver functions based on Screening lab results.\n* Known hypersensitivity to nalbuphine or to NAL ER excipients\n* History of major psychiatric disorder.\n* History of substance abuse.\n* Significant medical condition or other factors that may interfere with the participant\'s ability to successfully complete the study.\n* Pregnant or lactating female participant.\n* Known intolerance (gastrointestinal, central nervous system symptoms), hypersensitivity, drug allergy following the use of an opioid drug.\n* Use of opiates is prohibited within 14 days prior to the baseline visit.\n* Use of benzodiazepines are prohibited within 14 days prior to the baseline visit and for the duration of the study.\n* 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.\n* Use of oral corticosteroid cough treatment is prohibited within 4 weeks prior to the baseline visit and for the duration of the study.\n* Exposure to any investigational medication, including placebo, is prohibited within 4 weeks prior to the baseline visit and for the duration of the study.\n* 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.\n* 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.\n* 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.\n* 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.\n* 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.\n* 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.\n\nOther protocol defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT05964335', 'acronym': 'CORAL', 'briefTitle': 'Cough Reduction in IPF With Nalbuphine ER', 'organization': {'class': 'INDUSTRY', 'fullName': 'Trevi Therapeutics'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'NAL03-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NAL ER 27 mg', 'description': 'BID', 'interventionNames': ['Drug: NAL ER']}, {'type': 'EXPERIMENTAL', 'label': 'NAL ER 54 mg', 'description': 'BID', 'interventionNames': ['Drug: NAL ER']}, {'type': 'EXPERIMENTAL', 'label': 'NAL ER 108 mg', 'description': 'BID', 'interventionNames': ['Drug: NAL ER']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo, BID', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'NAL ER', 'type': 'DRUG', 'otherNames': ['Nalbuphine'], 'description': 'Oral tablets', 'armGroupLabels': ['NAL ER 27 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral tablets', 'armGroupLabels': ['Placebo']}, {'name': 'NAL ER', 'type': 'DRUG', 'otherNames': ['Nalbuphine'], 'description': 'Oral Tablets', 'armGroupLabels': ['NAL ER 54 mg']}, {'name': 'NAL ER', 'type': 'DRUG', 'otherNames': ['Nalbuphine'], 'description': 'Oral tablets', 'armGroupLabels': ['NAL ER 108 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3128', 'city': 'Box Hill', 'country': 'Australia', 'facility': 'Eastern Health-Box Hill Hospital', 'geoPoint': {'lat': -37.81887, 'lon': 145.12545}}, {'zip': '2139', 'city': 'Concord', 'country': 'Australia', 'facility': 'Concord Repatriation General Hospital', 'geoPoint': {'lat': -33.84722, 'lon': 151.10381}}, {'zip': '3084', 'city': 'Heidelberg', 'country': 'Australia', 'facility': 'Austin Hospital', 'geoPoint': {'lat': -37.75, 'lon': 145.06667}}, {'zip': '5067', 'city': 'Kent Town', 'country': 'Australia', 'facility': 'Respiratory 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