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Hustenreduktion bei IPF mit Nalbuphin ER (CORAL)

2. Juni 2026 aktualisiert von: Trevi Therapeutics

Eine randomisierte, doppelblinde, placebokontrollierte, parallele, 4-armige Dosisfindungsstudie zur Sicherheit und Wirksamkeit von Nalbuphin-Retardtabletten (NAL ER) zur Behandlung von Husten bei idiopathischer Lungenfibrose (IPF)

Dies ist eine multizentrische, randomisierte, doppelblinde, placebokontrollierte, parallele, 4-armige Studie.

Nachdem die Eignung während des Screening-Zeitraums erfüllt ist, werden die Probanden randomisiert (1:1:1:1) einem von vier Behandlungsarmen zugeteilt.

  • Arm 1: Placebo
  • Arm 2: 27-mg-Dosisarm
  • Arm 3: 54-mg-Dosisarm
  • Arm 4: Arm mit 108-mg-Dosis Jeder Arm wird während der verblindeten 2-wöchigen Titrationsperiode auf seine feste Dosis titriert, gefolgt von der 4-wöchigen festen Dosisperiode für insgesamt 6 Wochen unter Medikamenteneinnahme.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Dies ist eine multizentrische, randomisierte, doppelblinde, placebokontrollierte, parallele, 4-armige Studie.

Nachdem die Eignung während des Screening-Zeitraums erfüllt ist, werden die Probanden randomisiert (1:1:1:1) einem von vier Behandlungsarmen zugeteilt.

  • Arm 1: Placebo
  • Arm 2: 27-mg-Dosisarm
  • Arm 3: 54-mg-Dosisarm
  • Arm 4: 108-mg-Dosisarm Jeder Arm wird während der verblindeten zweiwöchigen Titrationsperiode gemäß Tabelle: Dosierungsschema auf seine feste Dosis titriert, gefolgt von der 4-wöchigen festen Dosisperiode für insgesamt 6 Wochen Medikamenteneinnahme.

Den Probanden wird am Ende des Zeitraums mit fester Dosis das Studienmedikament entzogen und die Behandlung für weitere 2 Wochen fortgesetzt.

Sollte es zu einem dauerhaften Abbruch des Prüfpräparats zu irgendeinem Zeitpunkt kommen, sollte der Proband zu Absetzungs- und Sicherheitsnachuntersuchungen zurückkehren. Sie werden dann in Woche 6 telefonisch kontaktiert, um Informationen zu schwerwiegenden unerwünschten Ereignissen (SAEs) und zum Vitalstatus zu sammeln.

Ein unabhängiges Data Safety Monitoring Board (DSMB) überprüft regelmäßig ausgewählte Daten.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

165

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Australien
      • Box Hill, Australien, 3128
        • Eastern Health-Box Hill Hospital
      • Concord, Australien, 2139
        • Concord Repatriation General Hospital
      • Heidelberg, Australien, 3084
        • Austin Hospital
      • Kent Town, Australien, 5067
        • Respiratory Clinical Trials PTY Ltd
      • Spearwood, Australien, 6163
        • TrialsWest Pty Ltd
      • Westmead, Australien, 2145
        • Westmead Hospital
  • Chile
      • Concepción, Chile, 4040324
        • Hospital Clinico Regional Dr. Guillermo Grant Benavente
      • Quillota, Chile, 2260877
        • Centro Respiratorio Integral Ltda
      • Santiago, Chile, 7620157
        • Clinica Universidad de Los Andes
      • Talca, Chile, 3467384
        • Centro de Investigacion del Maule
      • Valparaíso, Chile, 2352499
        • Hospital Carlos Van Buren
      • Villa Del Mar, Chile, 2520598
        • Centro de Investigaciones de Enfermedades Respiratorias e Immunologic Limitada
  • Deutschland
      • Essen, Deutschland, 45239
        • Universitatsklinik Ruhrlandklinik, Westdeutsches Lungenzentrum
      • Frankfurt am Main, Deutschland, 60596
        • IKF Institut fuer klinische Forschung Frankfurt
      • Hanover, Deutschland, 30625
        • Medizinische Hochschule Hannover, Hannover Medical School
      • Leipzig, Deutschland, 04103
        • University Hospital of Leipzig
      • Mainz, Deutschland, 55131
        • University Medical Center of Johannes Gutenberg-University Mainz
      • Mainz, Deutschland, 55128
        • IKF Pneumologie Mainz, Helix Medical Excellence Center Mainz
      • Solingen, Deutschland, 42699
        • Krankenhaus Bethanien
  • Italien
      • Catania, Italien, 95123
        • Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele- Ospedale Gaspare Rodolico
      • Foggia, Italien, 71122
        • Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia
      • Monza, Italien, 20900
        • Azienda Ospedaliera San Gerardo di Monza
      • Padua, Italien, 35128
        • Azienda Ospedaliera Di Padova
      • Rome, Italien, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • Kanada
      • Ajax, Kanada, L1S 2J5
        • Dynamic Drug Advancement
      • Vancouver, Kanada, V5Z 1M9
        • Centre for Lung Health Clinic
      • Vancouver, Kanada, V6Z 1Y6
        • The Pacific Lung Health Centre - St. Pauls Hospital
    • Quebec
      • Trois-Rivières, Quebec, Kanada, G8T 7A1
        • CIC Mauricie inc.
  • Niederlande
      • 's-Hertogenbosch, Niederlande, 5223 GZ
        • Jeroen Bosch Ziekenhuis
      • Groningen, Niederlande, 9728 NT
        • Martini Ziekenhuis
      • Rotterdam, Niederlande, 3015 GD
        • Erasmus Medisch Centrum 1
      • The Hague, Niederlande, 2512 VA
        • HMC (Haaglanden Medisch Centrum) Bronovo
  • Polen
      • Gdansk, Polen, 80-214
        • Uniwersyteckie Centrum Kliniczne (UCK)
      • Lodz, Polen, 90-153
        • Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego
      • Olsztyn, Polen, 10-357
        • Warminsko Mazurskie Centrum Chorob Pluc w Olsztynie
      • Szczecin, Polen, 70-891
        • Samodzielny Publiczny Wojewodzki Szpital Zespolony w Szczecinie
  • Spanien
      • Barcelona, Spanien, 08907
        • Hospital Universitari de Bellvitge
      • Barcelona, Spanien, 08017
        • Clinica Mi Tres Torres Barcelona
      • Madrid, Spanien, 28010
        • Hospital La Milagrosa
      • Santander, Spanien, 39008
        • HUMV
  • Türkei (türkiye)
      • Ankara, Türkei (türkiye), 06010
        • Gulhane Askeri Tip Akademisi (GATA) - Gulhane Askeri Tip Fakultesi (Gulhane Military Medical Academy and Medical School)
      • Antalya, Türkei (türkiye), 7070
        • Akdeniz University Faculty of Medicine
      • Istanbul, Türkei (türkiye), 34854
        • Sureyyapasa Gogus Hastaliklari ve Gogus Cerrahisi Egitim ve Arastirma Hastanesi
      • Izmir, Türkei (türkiye), 35100
        • Ege University Medical Faculty
      • Konya, Türkei (türkiye), 42130
        • Selcuk Universty Medical Faculty
      • Çanakkale, Türkei (türkiye), 17020
        • Canakkale Onsekiz Mart Universitesi (COMU) - Tip Fakultesi Hastanesi
  • Vereinigtes Königreich
      • Birmingham, Vereinigtes Königreich, B15 2GW
        • Queen Elizabeth Hospital Birmingham - University Hospitals Birmingham NHS Foundation Trust
      • Cambridge, Vereinigtes Königreich, CB2 0AY
        • Royal Papworth Hospital
      • Cottingham, Vereinigtes Königreich, HU16 5JQ
        • Hull and East Yorkshire - Castle Hill Hospital
      • Edinburgh, Vereinigtes Königreich, EH16 4SA
        • Royal Infirmary of Edinburgh
      • London, Vereinigtes Königreich, SW3 6NP
        • Royal Brompton Hospital
      • London, Vereinigtes Königreich, NW1 2PG
        • University College London
      • Londonderry, Vereinigtes Königreich, BT47 6SB
        • Altnagelvin Area Hospital
      • Manchester, Vereinigtes Königreich, M23 9LT
        • Wythenshawe Hospital
      • Norwich, Vereinigtes Königreich, NR4 7UY
        • Norfolk and Norwich University Hospital
      • Nottingham, Vereinigtes Königreich, NG5 1PB
        • Nottingham City Hospital
      • Oxford, Vereinigtes Königreich, OX3 7LE
        • Churchill Hospital
      • Portadown, Vereinigtes Königreich, BT63 5QQ
        • Southern Health & Social Care Trust, Craigavon Area Hospital
      • Southampton, Vereinigtes Königreich, SO16 6YD
        • Southampton General Hospital

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Einschlusskriterien:

  1. Diagnose von IPF, wie vom Hauptprüfarzt auf der Grundlage der ATS/ERS/JRS/ALAT-Richtlinien festgelegt.
  2. Hustenschweregrad-Score ≥ 4 auf der CS-NRS (Numerische Bewertungsskala für den Hustenschweregrad) während des Screening-Zeitraums und der Baseline.
  3. Chronischer Husten in der Anamnese seit mindestens 8 Wochen vor dem Screening.
  4. SpO2 ≥ 92 %, gemessen nach mindestens 5 Minuten in sitzender Position, ungestört und nicht stimuliert (Sättigung von Hämoglobin mit Sauerstoff, gemessen durch Pulsoximetrie).
  5. FVC ≥ 40 % des Normalwerts – Forcierte Vitalkapazität, bestimmt durch Spirometrie gemäß den ATS/ERS-Richtlinien.
  6. DLCO ≥ 25 % des Normalwerts – Diffusionskapazität der Lunge für Kohlenmonoxid, korrigiert um Hämoglobin, ermittelt innerhalb der letzten 12 Wochen oder zum Zeitpunkt des Screenings.

Ausschlusskriterien:

  1. Derzeit unter kontinuierlicher Sauerstofftherapie für mehr als 16 Stunden auf jeder Stufe oder durch eine beliebige Modalität. Eine intermittierende Sauerstoffanwendung beliebiger Dauer über einen Zeitraum von 24 Stunden ist zulässig.
  2. Unzureichender Schluckreflex, gemessen an der Fähigkeit, 89 ml Wasser zu trinken, ohne zu husten oder zu würgen.
  3. Infektion der oberen oder unteren Atemwege in den letzten 8 Wochen vor dem Basisbesuch.
  4. Klinische Vorgeschichte einer Aspirationspneumonitis.
  5. Diagnose von Schlafapnoe.
  6. Vorgeschichte einer schweren psychiatrischen Störung.
  7. Geschichte des Drogenmissbrauchs.
  8. Erheblicher medizinischer Zustand oder andere Faktoren, die die Fähigkeit des Probanden beeinträchtigen können, die Studie erfolgreich abzuschließen.
  9. Schwangere oder stillende weibliche Person.
  10. Bekannte Unverträglichkeiten (Magen-Darm-Symptome, Symptome des Zentralnervensystems), Überempfindlichkeit, Arzneimittelallergie nach der Einnahme eines Opioid-Arzneimittels.
  11. Der Konsum von Opiaten ist innerhalb von 14 Tagen vor dem Basisbesuch verboten.
  12. Die Verwendung von Benzodiazepinen ist innerhalb von 14 Tagen vor dem Basisbesuch und für die Dauer der Studie verboten.
  13. Monoaminoxidasehemmer (MAOIs), einschließlich Methylenblau (Methylthioniniumchlorid) und das Antibiotikum Linezolid, sind innerhalb von 14 Tagen vor dem Basisbesuch und für die Dauer der Studie verboten.
  14. Die Anwendung einer oralen Kortikosteroid-Hustenbehandlung ist innerhalb von 4 Wochen vor dem Basisbesuch und für die Dauer der Studie verboten.
  15. Der Kontakt mit Prüfmedikamenten, einschließlich Placebo, ist innerhalb von 4 Wochen vor dem Basisbesuch und für die Dauer der Studie verboten.
  16. Medikamente, die als Hustenmittel verschrieben werden, sind verboten, es sei denn, sie werden 14 Tage vor dem Basisbesuch in einer stabilen Dosis eingenommen, und es wird erwartet, dass diese Dosis für die Dauer der Studie beibehalten wird.
  17. Die Einnahme von Arzneimitteln, die die serotonerge Neurotransmission beeinflussen und bei gleichzeitiger Anwendung mit Opioiden das Risiko eines Serotonin-Syndroms erhöhen können, ist verboten, es sei denn, sie werden 14 Tage vor dem Basisbesuch in einer stabilen Dosis eingenommen und es wird erwartet, dass diese Dosis für die Dauer der Studie beibehalten wird .
  18. Antifibrotische Medikamente sind verboten, es sei denn, sie werden 8 Wochen vor dem Basisbesuch in einer stabilen Dosis eingenommen, und es wird erwartet, dass diese Dosis für die Dauer der Studie beibehalten wird.
  19. Starke Inhibitoren/Induktoren der P450-Isozyme sind verboten, es sei denn, sie erhalten 14 Tage vor dem Basisbesuch eine stabile Dosis und es wird erwartet, dass diese Dosis für die Dauer der Studie beibehalten wird.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: NAL ER 27 mg
Participants were titrated over 2 weeks to NAL ER 27 mg BID, then maintained at the fixed dose for 4 weeks (total 6 weeks of treatment).
Arzneimittel: NAL ER
Orale Tabletten
Andere Namen:
  • Nalbuphin
Arzneimittel: NAL ER
Orale Tabletten
Andere Namen:
  • Nalbuphin
Experimental: NAL ER 54 mg
Participants were titrated over 2 weeks to NAL ER 54 mg BID, then maintained at the fixed dose for 4 weeks (total 6 weeks of treatment).
Arzneimittel: NAL ER
Orale Tabletten
Andere Namen:
  • Nalbuphin
Arzneimittel: NAL ER
Orale Tabletten
Andere Namen:
  • Nalbuphin
Experimental: NAL ER 108 mg
Participants were titrated over 2 weeks to NAL ER 108 mg BID, then maintained at the fixed dose for 4 weeks (total 6 weeks of treatment).
Arzneimittel: NAL ER
Orale Tabletten
Andere Namen:
  • Nalbuphin
Arzneimittel: NAL ER
Orale Tabletten
Andere Namen:
  • Nalbuphin
Placebo-Komparator: Placebo
Participants received a matching placebo BID, using the same 2-week blinded titration schedule and 4-week fixed-dose period as the active treatment arms (6 weeks total).
Arzneimittel: Placebo
Orale Tabletten

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Relative Change From Baseline in 24-hour Cough Frequency at Week 6
Zeitfenster: Baseline, Week 6
Relative change in 24-hour (combined daytime and nighttime) cough frequency (coughs per hour) from baseline was assessed. Assessment was done using objective digital cough monitoring. The relative change from baseline = [ (Post-baseline - Baseline) / Baseline] × 100. The baseline value was defined as the last non-missing observation prior to the date of the first dose of study.
Baseline, Week 6

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Relative Change From Baseline in Evaluating Respiratory Symptoms in Idiopathic Pulmonary Fibrosis (E-RS:IPF) Cough Subscale at Week 6
Zeitfenster: Baseline, Week 6
The E-RS:IPF is a respiratory symptom subscale of the exacerbation of chronic pulmonary disease tool (EXACT) and consists of 11 items and was developed for use in IPF. The Cough subscale includes a single item (item 2: How often did you cough today?). The possible score range is 0 (not at all) to 4 (almost constantly). Higher scores indicate more severe symptoms. The relative change from baseline values is presented below. The relative change from baseline = [ (Post-baseline - Baseline) / Baseline] × 100. A positive change from baseline indicates worsening. The baseline value was defined as the last non-missing observation prior to the date of the first dose of study.
Baseline, Week 6
Number of Participants Who Experienced at Least One Treatment Emergent Adverse Events (TEAEs)
Zeitfenster: Up to Week 12
An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A TEAE was defined as any AE that occurs after the first dose of study drug. TEAEs included both serious and non-serious TEAEs.
Up to Week 12
Relative Change From Baseline in 24-hour Cough Frequency at Week 6
Zeitfenster: Baseline, Weeks 6
Relative change in 24-hour (combined daytime and nighttime) cough frequency (coughs per hour) from baseline was assessed. Assessment was done using objective digital cough monitoring. The relative change from baseline = [ (Post-baseline - Baseline) / Baseline] × 100. The baseline value was defined as the last non-missing observation prior to the date of the first dose of study.
Baseline, Weeks 6
Percentage of Responders With ≥30%, ≥50% and ≥75% Reduction in the 24-Hour Cough Frequency at Week 6
Zeitfenster: At Week 6
Responders were defined as those with ≥30%, ≥50%, or ≥75% reduction in 24-hour cough frequency from Baseline at Week 6. Percentages were rounded off to the nearest decimal.
At Week 6
Relative Change From Baseline in Awake Cough Frequency at Week 6
Zeitfenster: Baseline, Week 6
Awake cough was defined as cough that occurs between the time that the participant is awaken 24 hours after the digital cough monitor was applied for use. Assessment was done using objective digital cough monitoring. The relative change from baseline = [ (Post-baseline - Baseline) / Baseline] × 100. The baseline value was defined as the last non-missing observation prior to the date of the first dose of study.
Baseline, Week 6
Relative Change From Baseline in Sleep Cough Frequency at Week 6
Zeitfenster: Baseline, Week 6
Sleep cough frequency was intended as the average coughs per hour while the participant was flagged as being asleep. Assessment was done using objective digital cough monitoring. Percent change in cough frequency (coughs per hour) from baseline was assessed. The relative change from baseline = [ (Post-baseline - Baseline) / Baseline] × 100. The baseline value was defined as the last non-missing observation prior to the date of the first dose of study.
Baseline, Week 6
Relative Change From Baseline in E-RS: IPF Cough Subscale at Week 6
Zeitfenster: Baseline, Week 6
The E-RS:IPF is a respiratory symptom subscale of the EXACT and consists of 11 items and was developed for use in IPF. The Cough subscale includes a single item (item 2: How often did you cough today?) with a score range of 0 (not at all) to 4 (almost constantly). The relative change from baseline values is presented below. The relative change from baseline = [ (Post-baseline - Baseline) / Baseline] × 100. A positive change from baseline indicates worsening. The baseline value was defined as the last non-missing observation prior to the date of the first dose of study.
Baseline, Week 6
Percentage of E-RS: IPF Cough Subscale Responders With At Least One Category Improvement at Week 6
Zeitfenster: At Week 6
The E-RS:IPF is a respiratory symptom subscale of the EXACT and consists of 11 items and was developed for use in IPF. The Cough subscale includes a single item (item 2) with a score range of 0 (not at all) to 4 (almost constantly). Responders are defined as those with at least one category reduction (improvement) by ≥1 point at Week 6. Percentages were rounded off to the nearest decimal.
At Week 6
Change From Baseline in E-RS:IPF Total Score at Week 6
Zeitfenster: Baseline, Week 6
The Total E-RS:IPF includes all 11 items from the scale and was developed for use in IPF. Items assignments to domains of the E-RS:IPF are as follows: the RS-Breathlessness domain (Items 7-11) has a score range of 0-23; the IPF-Chest domain (Items 1, 5, and 6) has a score range of 0-12; the IPF-Cough domain (Item 2) has a score range of 0-4; the IPF-Sputum domain (Items 3 and 4) has a score range of 0-8; and the E-RS:IPF total score (Items 1-11) ranges from 0-47. For each day, the sum of the item-level raw scores forms the E-RS:IPF total score. Higher scores indicate more severe symptoms. A negative change from Baseline indicates improvement. The baseline value was defined as the last non-missing observation prior to the date of the first dose of study.
Baseline, Week 6
Change From Baseline in IPF-Breathlessness Subdomain Score at Week 6
Zeitfenster: Baseline, Week 6
The E-RS:IPF consists of a subset of 11 items from the EXACT and was developed for use in IPF. The Breathlessness subdomain score includes 5 items (Item 7: Were you breathless today, Item 8: Describe how breathless you were today, Item 9: Were you short of breath today when performing your usual personal care activities like washing or dressing, Item 10: Were you short of breath today when performing your usual indoor activities like cleaning or household work, Item 11: Were you short of breath today when performing your usual activities outside the home such as yard work or errands), all of which required the participant to report the effect of activities on shortness of breath. The possible score range is 0 to 23. A negative change from Baseline indicates improvement. The baseline value was defined as the last non-missing observation prior to the date of the first dose of study. A higher score indicates more severe symptoms.
Baseline, Week 6
Change From Baseline in IPF-Cough Subdomain Score at Week 6
Zeitfenster: Baseline, Week 6
The E-RS:IPF is a respiratory symptom subscale of the EXACT and consists of 11 items and was developed for use in IPF. The Cough subdomain score includes single item (item 2: How often did you cough today?) The possible score range is 0 (not at all) to 4 (almost constantly). A higher score indicates more severe symptoms. A negative change from baseline indicates improvement. The baseline value was defined as the last non-missing observation prior to the date of the first dose of study.
Baseline, Week 6
Change From Baseline in IPF-Sputum Subdomain Score at Week 6
Zeitfenster: Baseline, Week 6
The E-RS:IPF is a respiratory symptom subscale of the EXACT and consists of 11 items and was developed for use in IPF. The Sputum subdomain score includes 2 items (Item 3: How much mucus (phlegm) did you bring up when coughing today? and Item 4: How difficult was it to bring up mucus (phlegm) today?), which ask about quantity and difficulty in bringing up phlegm. The possible score range is 0-8. Higher score indicates more severe symptoms. A negative change from baseline indicates improvement. The baseline value was defined as the last non-missing observation prior to the date of the first dose of study.
Baseline, Week 6
Change From Baseline in IPF-Chest Subdomain Score at Week 6
Zeitfenster: Baseline, Week 6
The E-RS:IPF is a respiratory symptom subscale of the EXACT and consists of 11 items and was developed for use in IPF. The Chest subdomain score includes 3 items (Item 1: (Did your chest feel congested today?), Item 5: (Did you have chest discomfort today?), and Item 6: (Did your chest feel tight today?)). These questions solicited information on chest congestion, discomfort, and tightness. The possible score range is 0-12. A higher score indicates more severe symptoms. A negative change from baseline indicates improvement. The baseline value was defined as the last non-missing observation prior to the date of the first dose of study.
Baseline, Week 6
Change From Baseline in Cough Severity Numerical Rating Scale (CS-NRS) at Week 6
Zeitfenster: Baseline, Week 6
The CS-NRS is a single item scale in which participants described the severity of their cough in the past 24 hours on a scale of 0 (no cough) to 10 (worst possible cough). A negative change from Baseline indicates improvement. A higher score indicates more severe symptoms. The baseline value was defined as the last non-missing observation prior to the date of the first dose of study.
Baseline, Week 6
Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score at Week 6
Zeitfenster: Baseline, Week 6
LCQ is a self-reporting quality of life measure of chronic cough. It consists of 19 items with a 7-point Likert response scale ranging from 1 to 7. The responses are as follows: 1 = all of the time, 2 = most of the time, 3 = a good bit of the time, 4 = some of the time, 5 = a little of the time, 6 = hardly any of the time, and 7 = none of the time. Each item is designed to assess cough symptoms and the impact of cough across three main domains, physical (8 items), psychological (7 items), and social (4 items). Domain scores are calculated as the total score from items in the domain divided by the number of items in the domain and range from 1 to 7. The LCQ total score is calculated by summing the individual domain scores and ranges from 3 to 21, with higher scores indicating better health status. The baseline value was defined as the last non-missing observation prior to the date of the first dose of study.
Baseline, Week 6
Percentage of LCQ Total Score Responders With 1.3-Point Increase Response at Week 6
Zeitfenster: At Week 6
LCQ is a self-reporting quality of life measure of chronic cough. It consists of 19 items with a 7-point Likert response scale ranging from 1 to 7. The responses are as follows: 1 = all of the time, 2 = most of the time, 3 = a good bit of the time, 4 = some of the time, 5 = a little of the time, 6 = hardly any of the time, and 7 = none of the time. Each item is designed to assess cough symptoms and the impact of cough across three main domains, physical (8 items), psychological (7 items), and social (4 items). Domain scores are calculated as the total score from items in the domain divided by the number of items in the domain and range from 1 to 7. The LCQ total score is calculated by summing the individual domain scores and ranges from 3 to 21, with higher scores indicating better health status. Percentage of LCQ Total Score responders are presented in this outcome measure. Percentages were rounded off to the nearest decimal.
At Week 6
Change From Baseline in LCQ Domains at Week 6
Zeitfenster: Baseline, Week 6
LCQ is a self-reporting quality of life measure of chronic cough. It consists of 19 items with a 7-point Likert response scale ranging from 1 to 7. The responses are as follows: 1 = all of the time, 2 = most of the time, 3 = a good bit of the time, 4 = some of the time, 5 = a little of the time, 6 = hardly any of the time, and 7 = none of the time. Each item is designed to assess cough symptoms and the impact of cough across three main domains, physical (8 items), psychological (7 items), and social (4 items). Domain scores are calculated as the total score from items in the domain divided by the number of items in the domain and each domain score ranges from 1 to 7. Higher scores indicate better physical, psychological, and social status respectively. The baseline value was defined as the last non-missing observation prior to the date of the first dose of study.
Baseline, Week 6
Change From Baseline in Living With Pulmonary Fibrosis Impacts Questionnaire (L-IPF©) Impacts Raw Sum Score at Week 6
Zeitfenster: Baseline, Week 6
The L-IPF questionnaire is a 35-item questionnaire with two modules: symptoms (15 items) and impacts (20 items). The Impacts module yields a single Impacts score that is presented in this outcome measure. Each item's score ranges from 0-3. The score range for the L-IPF overall impacts raw sum score is 0-60, with higher scores indicating severe adverse impact. A negative change from Baseline indicates improvement. The baseline value was defined as the last non-missing observation prior to the date of the first dose of study.
Baseline, Week 6
Change From Baseline in L-IPF Symptoms Domain Scores at Week 6
Zeitfenster: Baseline, Week 6
The L-IPF questionnaire is a 35-item questionnaire with two modules: symptoms (15 items) and impacts (20 items). The L-IPF Symptoms module measures the various symptoms associated with IPF. The module contains 15 items that fall into 3 domains: Dyspnea, Cough, and Energy. Each item consists of a 0-3 score range. Dyspnea consists of 7 items and has a raw sum score range of 0-21 with higher scores indicating worsening dyspnea symptoms, Cough consists of 5 items and has a raw sum score range of 0-15 with higher scores indicating worsening cough symptoms, and Energy consists of 3 items and has a raw sum score range of 0-9 with higher scores indicating worsening energy. A negative change from Baseline indicates improvement. The baseline value was defined as the last non-missing observation prior to the date of the first dose of study.
Baseline, Week 6
Number of Participants With Shift From Baseline in European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L™) at Week 6
Zeitfenster: Baseline, Week 6
The EQ-5D-5L is a participant reported outcome and comprises of a descriptive system with 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). The recall period was the day that the questions were being completed. Each of the 5 dimensions in the descriptive system had 5 levels: 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems, and 5 = extreme problems. Higher scores indicate worsening. The baseline value was defined as the last non-missing observation prior to the date of the first dose of study.
Baseline, Week 6
Change From Baseline in Patient Global Impression of Severity (PGI-S) Cough Score at Week 6
Zeitfenster: Baseline, Week 6
The PGI-S cough scale is a self-reported, single-item categorical scale used for assessing chronic cough. Participants rated the severity of their cough in the last week with a 4-point Likert scale (0-3: 0 = No Cough, 1 = Mild, 2 = Moderate, or 3 = Severe). Higher scores indicate worsening. A negative change from Baseline indicates improvement. The baseline value was defined as the last non-missing observation prior to the date of the first dose of study.
Baseline, Week 6
Patient Global Impression of Change (PGI-C) Cough Score at Week 6
Zeitfenster: At Week 6
The PGI-C cough is a self-reported single-item 7-point scale that assesses participants' ratings of cough over the past 7 days. Participants rated their change as -3 = much better, -2 = moderately better, -1 = a little better, 0 = no change, 1 = a little worse, 2 = moderately worse, or 3 = much worse. Higher scores indicate worsening. A negative change from Baseline indicates improvement.
At Week 6
Percentage of Participants With Improvement by ≥1 and ≥ 2 on PGI-C Cough
Zeitfenster: At Week 6
The PGI-C cough is a self-reported single-item 7-point scale that assesses participants' ratings of cough over the past 7 days. Participants rated their change as -3 = much better, -2 = moderately better, -1 = a little better, 0 = no change, 1= a little worse, 2 = moderately worse, or 3 = much worse. Higher scores indicate worsening. Percentages were rounded off to the nearest decimal.
At Week 6
Percentage of Participants With Worsening by ≥1 and ≥2 on PGI-C Cough
Zeitfenster: At Week 6
The PGI-C cough is a self-reported single-item 7-point scale that assesses participants' ratings of cough over the past 7 days. Participants rated their change as -3 = much better, -2 = moderately better, -1 = a little better, 0 = no change, 1= a little worse, 2 = moderately worse, or 3 = much worse. Higher scores indicate worsening. Percentages were rounded off to the nearest decimal.
At Week 6
Percentage of Participants With no Change on PGI-C Cough
Zeitfenster: At Week 6
The PGI-C cough is a self-reported single-item 7-point scale that assesses participants' ratings of cough over the past 7 days. Participants rated their change as -3 = much better, -2 = moderately better, -1 = a little better, 0 = no change, 1= a little worse, 2 = moderately worse, or 3=much worse. Higher scores indicate worsening. Percentages were rounded off to the nearest decimal.
At Week 6
Percentage of Participants With Improvement by ≥1 and ≥2 on PGI-S Cough
Zeitfenster: At Week 6
The PGI-S cough scale is a self-reported, single-item categorical scale used for assessing chronic cough. Participants rated the severity of their cough in the last week with a 4-point Likert scale (0-3: 0 = No Cough, 1 = Mild, 2 = Moderate, or 3 = Severe). Higher scores indicate worsening. Percentages were rounded off to the nearest decimal.
At Week 6
Percentage of Participants With Worsening by ≥1 and ≥2 and PGI-S Cough
Zeitfenster: At Week 6
The PGI-S cough scale is a self-reported, single-item categorical scale used for assessing chronic cough. Participants rated the severity of their cough in the last week with a 4-point Likert scale (0-3: 0 = No Cough, 1 = Mild, 2 = Moderate, or 3 = Severe). Higher scores indicate worsening. Percentages were rounded off to the nearest decimal.
At Week 6
Percentage of Participants With no Change on PGI-S Cough
Zeitfenster: At Week 6
The PGI-S cough scale is a self-reported, single-item categorical scale used for assessing chronic cough. Participants rated the severity of their cough in the last week with a 4-point Likert scale (0-3: 0 = No Cough, 1 = Mild, 2 = Moderate, or 3 = Severe). Higher scores indicate worsening. Percentages were rounded off to the nearest decimal.
At Week 6
Change From Baseline in PGI-S IPF at Week 6
Zeitfenster: Baseline, Week 6
PGI-S IPF scale is a self-reported, single-item categorical scale that was used to assess symptoms of IPF. Participants rated the symptoms of IPF in the last week with a 4-point Likert scale (0-3: 0 = No symptoms, 1 = Mild, 2 = Moderate, or 3 = Severe). Higher scores indicate worsening. A negative change from Baseline indicates improvement. The baseline value was defined as the last non-missing observation prior to the date of the first dose of study.
Baseline, Week 6
PGI-C IPF Score at Week 6
Zeitfenster: At Week 6
The PGI-C IPF is a self-reported, single-item 7-point scale assessing a participant's rating of cough over the past 7 days. Participants rated their change as -3 = much better, -2 = moderately better, -1 = a little better, 0 = no change, 1 = a little worse, 2 = moderately worse, or 3 = much worse. Higher scores indicate worsening. A negative change from Baseline indicates improvement.
At Week 6
Percentage of Participants With Improvement by ≥1 and ≥2 on PGI-C IPF
Zeitfenster: At Week 6
The PGI-C IPF is a self-reported, single-item 7-point scale assessing a participant's rating of cough over the past 7 days. Participants rated their change as -3 = much better, -2 = moderately better, -1 = a little better, 0 = no change, 1= a little worse, 2 = moderately worse, or 3 = much worse. Higher scores indicate worsening. Percentages were rounded off to the nearest decimal.
At Week 6
Percentage of Participants With Worsening by ≥1 and ≥2 on PGI-C IPF
Zeitfenster: At Week 6
The PGI-C IPF is a self-reported, single-item 7-point scale assessing a participant's rating of cough over the past 7 days. Participants rated their change as -3 = much better, -2 = moderately better, -1= a little better, 0 = no change, 1= a little worse, 2 = moderately worse, or 3 = much worse. Higher scores indicate worsening. Percentages were rounded off to the nearest decimal.
At Week 6
Percentage of Participants With no Change on PGI-C IPF
Zeitfenster: At Week 6
The PGI-C IPF is a self-reported, single-item 7-point scale assessing a participant's rating of cough over the past 7 days. Participants rated their change as -3 = much better, -2 = moderately better, -1= a little better, 0 = no change, 1= a little worse, 2 = moderately worse, or 3 = much worse. Higher scores indicate worsening. Percentages were rounded off to the nearest decimal.
At Week 6
Percentage of Participants With Improvement by ≥1 and ≥2 on PGI-S-IPF
Zeitfenster: At Week 6
PGI-S IPF scale is a self-reported, single-item categorical scale that was used to assess symptoms of IPF. Participants rated the symptoms of IPF in the last week with a 4-point Likert scale (0-3: 0 = No symptoms, 1 = Mild, 2 = Moderate, or 3 = Severe). Higher scores indicate worsening. Percentages were rounded off to the nearest decimal.
At Week 6
Percentage of Participants With Worsening by ≥1 and ≥2 on PGI-S-IPF
Zeitfenster: At Week 6
PGI-S IPF scale is a self-reported, single-item categorical scale that was used to assess symptoms of IPF. Participants rated the symptoms of IPF in the last week with a 4-point Likert scale (0-3: 0 = No symptoms, 1 = Mild, 2 = Moderate, or 3 = Severe). Higher scores indicate worsening. Percentages were rounded off to the nearest decimal.
At Week 6
Percentage of Participants With no Change on PGI-S-IPF
Zeitfenster: At Week 6
PGI-S IPF scale is a self-reported, single-item categorical scale that was used to assess symptoms of IPF. Participants rated the symptoms of IPF in the last week with a 4-point Likert scale (0-3: 0 = No symptoms, 1 = Mild, 2 = Moderate, or 3 = Severe). Higher scores indicate worsening. Percentages were rounded off to the nearest decimal.
At Week 6
Change From Baseline in Clinicians Global Impression of Severity (CGI-S) Score at Week 6
Zeitfenster: Baseline, Week 6
The CGI-S is a single-item measure on which the clinician rates the participant's cough. CGI-S have score range of 0-3. (0 = no cough, 1 = mild, 2 = moderate, 3 = severe). Higher scores indicate greater severity of cough. A negative change from Baseline indicates improvement. The baseline value was defined as the last non-missing observation prior to the date of the first dose of study.
Baseline, Week 6
CGI-C IPF Score at Week 6
Zeitfenster: At Week 6
The CGI-C is a one-item measure evaluating change from the initiation of treatment on a seven-point scale. CGI-C have score range 1-7 (1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse. Higher scores indicate greater severity of cough.
At Week 6
Percentage of Participants With Improvement by ≥1 and ≥2 on the Clinicians Global Impression of Change (CGI-C) at Week 6
Zeitfenster: At Week 6
The CGI-C is a one-item measure evaluating change from the initiation of treatment on a seven-point scale. CGI-C have score range 1-7 (1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse. Higher scores indicate greater severity of cough. Percentages were rounded off to the nearest decimal.
At Week 6
Percentage of Participants With Worsening by ≥1 and ≥2 on the CGI-C at Week 6
Zeitfenster: At Week 6
The CGI-C is a one-item measure evaluating change from the initiation of treatment on a seven-point scale. CGI-C have score range 1-7 (1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse. Higher scores indicate greater severity of cough. Percentages were rounded off to the nearest decimal.
At Week 6
Percentage of Participants With no Change on the CGI-C at Week 6
Zeitfenster: At Week 6
The CGI-C is a one-item measure evaluating change from the initiation of treatment on a seven-point scale. CGI-C have score range 1-7 (1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse. Higher scores indicate greater severity of cough. Percentages were rounded off to the nearest decimal.
At Week 6
Percentage of Participants With Improvement by ≥1 and ≥2 on the Clinicians Global Impression of Severity (CGI-S) at Week 6
Zeitfenster: At Week 6
The CGI-S is a single-item measure on which the clinician rates the participant's cough. CGI-S have score range 0-3 (0 = no cough, 1= mild, 2 = moderate, 3 = severe). Higher scores indicate greater severity of cough. Percentages were rounded off to the nearest decimal.
At Week 6
Percentage of Participants With Worsening by ≥1 and ≥2 on the CGI-S at Week 6
Zeitfenster: At Week 6
The CGI-S is a single-item measure on which the clinician rates the participant's cough. CGI-S have score range 0-3 (0 = no cough, 1= mild, 2 = moderate, 3 = severe). Higher scores indicate greater severity of cough. Percentages were rounded off to the nearest decimal.
At Week 6
Percentage of Participants With no Change on the CGI-S at Week 6
Zeitfenster: At Week 6
The CGI-S is a single-item measure on which the clinician rates the participant's cough. CGI-S have score range 0-3 (0 = no cough, 1= mild, 2 = moderate, 3 = severe). Higher scores indicate greater severity of cough. Percentages were rounded off to the nearest decimal.
At Week 6

Mitarbeiter und Ermittler

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Sponsor

Trevi Therapeutics

Ermittler

  • Studienleiter: Chief Development Officer, Trevi Therapeutics

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

6. Februar 2024

Primärer Abschluss (Tatsächlich)

24. April 2025

Studienabschluss (Tatsächlich)

24. April 2025

Studienanmeldedaten

Zuerst eingereicht

7. Juli 2023

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

19. Juli 2023

Zuerst gepostet (Tatsächlich)

27. Juli 2023

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

26. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

2. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • NAL03-202

Plan für individuelle Teilnehmerdaten (IPD)

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NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Ja

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