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Réduction de la toux dans l'IPF avec Nalbuphine ER (CORAL)

2 juin 2026 mis à jour par: Trevi Therapeutics

Une étude randomisée, en double aveugle, contrôlée par placebo, parallèle et à 4 bras portant sur l'innocuité et l'efficacité des comprimés de nalbuphine à libération prolongée (NAL ER) pour le traitement de la toux dans la fibrose pulmonaire idiopathique (FPI)

Il s'agit d'une étude multicentrique randomisée, en double aveugle, contrôlée par placebo, parallèle, à 4 bras.

Après avoir satisfait à l'éligibilité pendant la période de sélection, les sujets seront randomisés (1:1:1:1) dans l'un des quatre bras de traitement.

  • Bras 1 : Placebo
  • Bras 2 : bras dose 27 mg
  • Bras 3 : bras dose 54 mg
  • Bras 4 : Bras de dose de 108 mg Chaque bras sera titré à sa dose fixe pendant la période de titrage de 2 semaines en aveugle suivie de la période de dose fixe de 4 semaines pour un total de 6 semaines de traitement.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

Il s'agit d'une étude multicentrique randomisée, en double aveugle, contrôlée par placebo, parallèle, à 4 bras.

Après avoir satisfait à l'éligibilité pendant la période de sélection, les sujets seront randomisés (1:1:1:1) dans l'un des quatre bras de traitement.

  • Bras 1 : Placebo
  • Bras 2 : bras dose 27 mg
  • Bras 3 : bras dose 54 mg
  • Bras 4 : Bras de dose de 108 mg Chaque bras sera titré à sa dose fixe pendant la période de titrage de 2 semaines en aveugle selon le tableau : Schéma posologique, suivi de la période de dose fixe de 4 semaines pour un total de 6 semaines de traitement.

Les sujets seront retirés du médicament à l'étude à la fin de la période de dose fixe et suivis du traitement pendant 2 semaines supplémentaires.

Si l'arrêt permanent du produit expérimental se produit à tout moment, le sujet doit revenir pour des visites d'arrêt et de suivi de sécurité. Ils seront ensuite contactés à la semaine 6 par téléphone pour recueillir des informations sur les événements indésirables graves (EIG) et le statut vital.

Un comité indépendant de surveillance de la sécurité des données (DSMB) examinera périodiquement les données sélectionnées.

Type d'étude

Interventionnel

Inscription (Réel)

165

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Allemagne
      • Essen, Allemagne, 45239
        • Universitatsklinik Ruhrlandklinik, Westdeutsches Lungenzentrum
      • Frankfurt am Main, Allemagne, 60596
        • IKF Institut fuer klinische Forschung Frankfurt
      • Hanover, Allemagne, 30625
        • Medizinische Hochschule Hannover, Hannover Medical School
      • Leipzig, Allemagne, 04103
        • University Hospital of Leipzig
      • Mainz, Allemagne, 55131
        • University Medical Center of Johannes Gutenberg-University Mainz
      • Mainz, Allemagne, 55128
        • IKF Pneumologie Mainz, Helix Medical Excellence Center Mainz
      • Solingen, Allemagne, 42699
        • Krankenhaus Bethanien
  • Australie
      • Box Hill, Australie, 3128
        • Eastern Health-Box Hill Hospital
      • Concord, Australie, 2139
        • Concord Repatriation General Hospital
      • Heidelberg, Australie, 3084
        • Austin Hospital
      • Kent Town, Australie, 5067
        • Respiratory Clinical Trials PTY Ltd
      • Spearwood, Australie, 6163
        • TrialsWest Pty Ltd
      • Westmead, Australie, 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
  • Espagne
      • Barcelona, Espagne, 08907
        • Hospital Universitari de Bellvitge
      • Barcelona, Espagne, 08017
        • Clinica Mi Tres Torres Barcelona
      • Madrid, Espagne, 28010
        • Hospital La Milagrosa
      • Santander, Espagne, 39008
        • HUMV
  • Italie
      • Catania, Italie, 95123
        • Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele- Ospedale Gaspare Rodolico
      • Foggia, Italie, 71122
        • Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia
      • Monza, Italie, 20900
        • Azienda Ospedaliera San Gerardo di Monza
      • Padua, Italie, 35128
        • Azienda Ospedaliera di Padova
      • Rome, Italie, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • Pays-Bas
      • 's-Hertogenbosch, Pays-Bas, 5223 GZ
        • Jeroen Bosch Ziekenhuis
      • Groningen, Pays-Bas, 9728 NT
        • Martini Ziekenhuis
      • Rotterdam, Pays-Bas, 3015 GD
        • Erasmus Medisch Centrum 1
      • The Hague, Pays-Bas, 2512 VA
        • HMC (Haaglanden Medisch Centrum) Bronovo
  • Pologne
      • Gdansk, Pologne, 80-214
        • Uniwersyteckie Centrum Kliniczne (Uck)
      • Lodz, Pologne, 90-153
        • Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego
      • Olsztyn, Pologne, 10-357
        • Warminsko Mazurskie Centrum Chorob Pluc w Olsztynie
      • Szczecin, Pologne, 70-891
        • Samodzielny Publiczny Wojewodzki Szpital Zespolony w Szczecinie
  • Royaume-Uni
      • Birmingham, Royaume-Uni, B15 2GW
        • Queen Elizabeth Hospital Birmingham - University Hospitals Birmingham NHS Foundation Trust
      • Cambridge, Royaume-Uni, CB2 0AY
        • Royal Papworth Hospital
      • Cottingham, Royaume-Uni, HU16 5JQ
        • Hull and East Yorkshire - Castle Hill Hospital
      • Edinburgh, Royaume-Uni, EH16 4SA
        • Royal Infirmary of Edinburgh
      • London, Royaume-Uni, SW3 6NP
        • Royal Brompton Hospital
      • London, Royaume-Uni, NW1 2PG
        • University College London
      • Londonderry, Royaume-Uni, BT47 6SB
        • Altnagelvin Area Hospital
      • Manchester, Royaume-Uni, M23 9LT
        • Wythenshawe Hospital
      • Norwich, Royaume-Uni, NR4 7UY
        • Norfolk and Norwich University Hospital
      • Nottingham, Royaume-Uni, NG5 1PB
        • Nottingham City Hospital
      • Oxford, Royaume-Uni, OX3 7LE
        • Churchill Hospital
      • Portadown, Royaume-Uni, BT63 5QQ
        • Southern Health & Social Care Trust, Craigavon Area Hospital
      • Southampton, Royaume-Uni, SO16 6YD
        • Southampton General Hospital
  • Turquie (Türkiye)
      • Ankara, Turquie (Türkiye), 06010
        • Gulhane Askeri Tip Akademisi (GATA) - Gulhane Askeri Tip Fakultesi (Gulhane Military Medical Academy and Medical School)
      • Antalya, Turquie (Türkiye), 7070
        • Akdeniz University Faculty of Medicine
      • Istanbul, Turquie (Türkiye), 34854
        • Sureyyapasa Gogus Hastaliklari ve Gogus Cerrahisi Egitim ve Arastirma Hastanesi
      • Izmir, Turquie (Türkiye), 35100
        • Ege University Medical Faculty
      • Konya, Turquie (Türkiye), 42130
        • Selcuk Universty Medical Faculty
      • Çanakkale, Turquie (Türkiye), 17020
        • Canakkale Onsekiz Mart Universitesi (COMU) - Tip Fakultesi Hastanesi

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Critère d'intégration:

  1. Diagnostic de FPI tel que déterminé par le chercheur principal sur la base des directives ATS/ERS/JRS/ALAT.
  2. Score de gravité de la toux ≥ 4 sur CS-NRS (échelle d'évaluation numérique de la gravité de la toux) pendant la période de dépistage et la ligne de base.
  3. Antécédents de toux chronique depuis au moins 8 semaines avant le dépistage.
  4. SpO2 ≥ 92 %, prise après au moins 5 minutes en position assise, non perturbée et non stimulée (saturation de l'hémoglobine en oxygène mesurée par oxymétrie de pouls).
  5. FVC ≥ 40 % prévu de la normale - Capacité vitale forcée, telle que déterminée par spirométrie conformément aux directives ATS/ERS.
  6. DLCO ≥ 25 % prévu de la normale - Capacité de diffusion du poumon pour le monoxyde de carbone corrigée pour l'hémoglobine, évaluée au cours des 12 dernières semaines ou au moment du dépistage.

Critère d'exclusion:

  1. Actuellement sous oxygénothérapie continue pendant plus de 16 heures à n'importe quel niveau ou administrée par n'importe quelle modalité. L'utilisation intermittente d'oxygène de n'importe quelle durée sur une période donnée de 24 heures est autorisée.
  2. Réflexe de déglutition inadéquat, évalué par la capacité à siroter 3 onces liquides (ou 89 ml) d'eau sans tousser ni s'étouffer.
  3. Infection des voies respiratoires supérieures ou inférieures au cours des 8 dernières semaines précédant la visite de référence.
  4. Antécédents cliniques de pneumonie par aspiration.
  5. Diagnostic de l'apnée du sommeil.
  6. Antécédents de trouble psychiatrique majeur.
  7. Antécédents de toxicomanie.
  8. Condition médicale importante ou autres facteurs pouvant interférer avec la capacité du sujet à mener à bien l'étude.
  9. Sujet féminin enceinte ou allaitante.
  10. Intolérance connue (gastro-intestinale, symptômes du système nerveux central), hypersensibilité, allergie médicamenteuse suite à l'utilisation d'un médicament opioïde.
  11. L'utilisation d'opiacés est interdite dans les 14 jours précédant la visite de référence.
  12. L'utilisation de benzodiazépines est interdite dans les 14 jours précédant la visite de référence et pendant toute la durée de l'étude.
  13. Les inhibiteurs de la monoamine oxydase (IMAO), y compris le bleu de méthylène (chlorure de méthylthioninium) et l'antibiotique linézolide, sont interdits dans les 14 jours précédant la visite initiale et pendant toute la durée de l'étude.
  14. L'utilisation d'un traitement contre la toux aux corticostéroïdes oraux est interdite dans les 4 semaines précédant la visite de référence et pendant toute la durée de l'étude.
  15. L'exposition à tout médicament expérimental, y compris le placebo, est interdite dans les 4 semaines précédant la visite de référence et pendant toute la durée de l'étude.
  16. Les médicaments prescrits comme antitussifs sont interdits à moins d'être à une dose stable 14 jours avant la visite de référence et devraient rester à cette dose pendant toute la durée de l'étude.
  17. L'utilisation de médicaments qui affectent la neurotransmission sérotoninergique et qui, lorsqu'ils sont utilisés en concomitance avec des opioïdes, peuvent augmenter le risque de syndrome sérotoninergique, est interdite, sauf à une dose stable 14 jours avant la visite de référence et devrait rester à cette dose pendant toute la durée de l'étude .
  18. Les médicaments anti-fibrotiques sont interdits à moins d'être à une dose stable pendant 8 semaines avant la visite de référence et devraient rester à cette dose pendant toute la durée de l'étude.
  19. Les inhibiteurs / inducteurs puissants des isoenzymes P450 sont interdits à moins d'être à une dose stable pendant 14 jours avant la visite de référence et devraient rester à cette dose pendant toute la durée de l'étude.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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).
Médicament: Nal er
Comprimés oraux
Autres noms:
  • Nalbuphine
Médicament: Nal er
Comprimés oraux
Autres noms:
  • Nalbuphine
Expérimental: 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).
Médicament: Nal er
Comprimés oraux
Autres noms:
  • Nalbuphine
Médicament: Nal er
Comprimés oraux
Autres noms:
  • Nalbuphine
Expérimental: 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).
Médicament: Nal er
Comprimés oraux
Autres noms:
  • Nalbuphine
Médicament: Nal er
Comprimés oraux
Autres noms:
  • Nalbuphine
Comparateur placebo: 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).
Médicament: Placebo
Comprimés oraux

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Relative Change From Baseline in 24-hour Cough Frequency at Week 6
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Relative Change From Baseline in Evaluating Respiratory Symptoms in Idiopathic Pulmonary Fibrosis (E-RS:IPF) Cough Subscale at Week 6
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Trevi Therapeutics

Les enquêteurs

  • Directeur d'études: Chief Development Officer, Trevi Therapeutics

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

6 février 2024

Achèvement primaire (Réel)

24 avril 2025

Achèvement de l'étude (Réel)

24 avril 2025

Dates d'inscription aux études

Première soumission

7 juillet 2023

Première soumission répondant aux critères de contrôle qualité

19 juillet 2023

Première publication (Réel)

27 juillet 2023

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

26 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

2 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • NAL03-202

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Oui

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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