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Hoestvermindering bij IPF met Nalbuphine ER (CORAL)

2 juni 2026 bijgewerkt door: Trevi Therapeutics

Een gerandomiseerde, dubbelblinde, placebogecontroleerde, parallelle, 4-armige dosisvariërende studie van de veiligheid en werkzaamheid van Nalbuphine-tabletten met verlengde afgifte (NAL ER) voor de behandeling van hoest bij idiopathische longfibrose (IPF)

Dit is een gerandomiseerde, dubbelblinde, placebogecontroleerde, parallelle, 4-armige studie in meerdere centra.

Nadat ze tijdens de screeningperiode in aanmerking zijn gekomen, worden proefpersonen gerandomiseerd (1:1:1:1) in een van de vier behandelingsarmen.

  • Arm 1: Placebo
  • Arm 2: 27 mg dosisarm
  • Arm 3: 54 mg dosisarm
  • Arm 4: 108 mg-dosisarm Elke arm wordt getitreerd tot hun vaste dosis tijdens de geblindeerde titratieperiode van 2 weken, gevolgd door de 4 weken durende vaste-dosisperiode voor een totaal van 6 weken behandeling met het geneesmiddel.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Dit is een gerandomiseerde, dubbelblinde, placebogecontroleerde, parallelle, 4-armige studie in meerdere centra.

Nadat ze tijdens de screeningperiode in aanmerking zijn gekomen, worden proefpersonen gerandomiseerd (1:1:1:1) in een van de vier behandelingsarmen.

  • Arm 1: Placebo
  • Arm 2: 27 mg dosisarm
  • Arm 3: 54 mg dosisarm
  • Arm 4: 108 mg-dosisarm Elke arm wordt getitreerd tot hun vaste dosis tijdens de geblindeerde titratieperiode van 2 weken volgens Tabel: Doseringsschema, gevolgd door de 4 weken durende vaste-dosisperiode voor een totaal van 6 weken op het geneesmiddel.

Proefpersonen zullen aan het einde van de vaste-dosisperiode van het onderzoeksgeneesmiddel worden gehaald en gedurende nog eens 2 weken worden behandeld.

Als het onderzoeksproduct op enig moment definitief wordt gestaakt, moet de proefpersoon terugkomen voor bezoeken voor stopzetting en veiligheidsopvolging. Vervolgens wordt er in week 6 telefonisch contact met hen opgenomen om informatie te verzamelen over ernstige ongewenste voorvallen (SAE's) en de vitale status.

Een onafhankelijke Data Safety Monitoring Board (DSMB) beoordeelt periodiek geselecteerde gegevens.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

165

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusiecriteria:

  1. Diagnose van IPF zoals bepaald door de hoofdonderzoeker op basis van ATS/ERS/JRS/ALAT-richtlijnen.
  2. Cough Severity Score ≥ 4 op CS-NRS (Cough Severity Numerical Rating Scale) tijdens de screeningperiode en baseline.
  3. Geschiedenis van chronische hoest gedurende ten minste 8 weken vóór screening.
  4. SpO2 ≥ 92%, genomen na ten minste 5 minuten in zittende houding, ongestoord en niet-gestimuleerd (verzadiging van hemoglobine met zuurstof zoals gemeten met pulsoximetrie).
  5. FVC ≥ 40% voorspeld van normaal - Geforceerde vitale capaciteit, zoals bepaald door middel van spirometrie volgens de ATS/ERS-richtlijnen.
  6. DLCO ≥ 25% voorspeld van normaal - Verspreidingscapaciteit van de long voor koolmonoxide gecorrigeerd voor hemoglobine, beoordeeld in de afgelopen 12 weken of op het moment van screening.

Uitsluitingscriteria:

  1. Momenteel langer dan 16 uur ononderbroken zuurstoftherapie op elk niveau of geleverd door elke modaliteit. Intermitterend zuurstofgebruik van welke duur dan ook gedurende een bepaalde periode van 24 uur is toegestaan.
  2. Ontoereikende slikreflex zoals beoordeeld door het vermogen om 3 vloeibare oz (of 89 ml) water te drinken zonder hoesten of stikken.
  3. Infectie van de bovenste of onderste luchtwegen in de laatste 8 weken voorafgaand aan het basisbezoek.
  4. Klinische geschiedenis van aspiratiepneumonitis.
  5. Diagnose van slaapapneu.
  6. Geschiedenis van een ernstige psychiatrische stoornis.
  7. Geschiedenis van middelenmisbruik.
  8. Significante medische toestand of andere factoren die kunnen interfereren met het vermogen van de proefpersoon om het onderzoek met succes af te ronden.
  9. Zwangere of zogende vrouwelijke proefpersoon.
  10. Bekende intolerantie (gastro-intestinale symptomen, symptomen van het centrale zenuwstelsel), overgevoeligheid, medicijnallergie na het gebruik van een opioïde medicijn.
  11. Gebruik van opiaten is verboden binnen 14 dagen voorafgaand aan het nulbezoek.
  12. Het gebruik van benzodiazepines is verboden binnen 14 dagen voorafgaand aan het basisbezoek en voor de duur van het onderzoek.
  13. Monoamineoxidaseremmers (MAO-remmers), waaronder methyleenblauw (methylthioniniumchloride) en het antibioticum linezolid, zijn verboden binnen 14 dagen voorafgaand aan het basisbezoek en voor de duur van het onderzoek.
  14. Het gebruik van orale hoestbehandeling met corticosteroïden is verboden binnen 4 weken voorafgaand aan het basisbezoek en voor de duur van het onderzoek.
  15. Blootstelling aan onderzoeksmedicatie, inclusief placebo, is verboden binnen 4 weken voorafgaand aan het basisbezoek en voor de duur van het onderzoek.
  16. Medicijnen die worden voorgeschreven als hoestonderdrukkers zijn verboden, tenzij ze 14 dagen voorafgaand aan het basisbezoek een stabiele dosis hebben ingenomen en er wordt verwacht dat ze die dosis gedurende de duur van het onderzoek blijven gebruiken.
  17. Het gebruik van medicijnen die de serotonerge neurotransmissie beïnvloeden en die bij gelijktijdig gebruik met opioïden het risico op het serotoninesyndroom kunnen verhogen, is verboden, tenzij 14 dagen voorafgaand aan het basisbezoek een stabiele dosis wordt ingenomen en die dosis naar verwachting zal blijven gedurende de duur van het onderzoek .
  18. Antifibrotische medicatie is verboden, tenzij op een stabiele dosis gedurende 8 weken voorafgaand aan het basisbezoek en er wordt verwacht dat deze dosis gedurende de duur van het onderzoek behouden blijft.
  19. Sterke remmers/inductoren van de P450-isozymen zijn verboden, tenzij ze gedurende 14 dagen voorafgaand aan het basisbezoek een stabiele dosis hebben gekregen en er wordt verwacht dat ze die dosis gedurende de hele studie blijven gebruiken.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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).
Geneesmiddel: Nal er
Orale tabletten
Andere namen:
  • Nalbufine
Geneesmiddel: Nal er
Orale tabletten
Andere namen:
  • Nalbufine
Experimenteel: 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).
Geneesmiddel: Nal er
Orale tabletten
Andere namen:
  • Nalbufine
Geneesmiddel: Nal er
Orale tabletten
Andere namen:
  • Nalbufine
Experimenteel: 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).
Geneesmiddel: Nal er
Orale tabletten
Andere namen:
  • Nalbufine
Geneesmiddel: Nal er
Orale tabletten
Andere namen:
  • Nalbufine
Placebo-vergelijker: 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).
Geneesmiddel: Placebo
Orale tabletten

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Relative Change From Baseline in 24-hour Cough Frequency at Week 6
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Relative Change From Baseline in Evaluating Respiratory Symptoms in Idiopathic Pulmonary Fibrosis (E-RS:IPF) Cough Subscale at Week 6
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

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Sponsor

Trevi Therapeutics

Onderzoekers

  • Studie directeur: Chief Development Officer, Trevi Therapeutics

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

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Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

6 februari 2024

Primaire voltooiing (Werkelijk)

24 april 2025

Studie voltooiing (Werkelijk)

24 april 2025

Studieregistratiedata

Eerst ingediend

7 juli 2023

Eerst ingediend dat voldeed aan de QC-criteria

19 juli 2023

Eerst geplaatst (Werkelijk)

27 juli 2023

Updates van studierecords

Laatste update geplaatst (Werkelijk)

26 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

2 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • NAL03-202

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Ja

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