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Reducción de la tos en la FPI con Nalbufina ER (CORAL)

2 de junio de 2026 actualizado por: Trevi Therapeutics

Un estudio aleatorizado, doble ciego, controlado con placebo, paralelo, de rango de dosis de 4 brazos sobre la seguridad y eficacia de las tabletas de liberación prolongada de nalbufina (NAL ER) para el tratamiento de la tos en la fibrosis pulmonar idiopática (IPF)

Este es un estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo, paralelo y de 4 brazos.

Después de cumplir con los requisitos de elegibilidad durante el Período de Selección, los sujetos serán aleatorizados (1:1:1:1) a uno de los cuatro brazos de tratamiento.

  • Brazo 1: Placebo
  • Brazo 2: Brazo de dosis de 27 mg
  • Brazo 3: Brazo de dosis de 54 mg
  • Brazo 4: Brazo de dosis de 108 mg Cada brazo se ajustará a su dosis fija durante el período de titulación ciego de 2 semanas seguido del período de dosis fija de 4 semanas para un total de 6 semanas con el fármaco.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Este es un estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo, paralelo y de 4 brazos.

Después de cumplir con los requisitos de elegibilidad durante el Período de Selección, los sujetos serán aleatorizados (1:1:1:1) a uno de los cuatro brazos de tratamiento.

  • Brazo 1: Placebo
  • Brazo 2: Brazo de dosis de 27 mg
  • Brazo 3: Brazo de dosis de 54 mg
  • Brazo 4: Brazo de dosis de 108 mg Cada brazo se titulará a su dosis fija durante el período de titulación ciego de 2 semanas de acuerdo con la Tabla: Esquema de dosificación, seguido por el Período de dosis fija de 4 semanas para un total de 6 semanas con el fármaco.

A los sujetos se les retirará el fármaco del estudio al final del Período de dosis fija y se seguirá el tratamiento durante 2 semanas adicionales.

Si se produce la interrupción permanente del producto en investigación en cualquier momento, el sujeto debe regresar para las visitas de seguimiento de seguridad y de interrupción. Luego serán contactados en la semana 6 por teléfono para recopilar información sobre eventos adversos graves (SAE) y estado vital.

Una Junta de Monitoreo de Seguridad de Datos (DSMB) independiente revisará periódicamente los datos seleccionados.

Tipo de estudio

Intervencionista

Inscripción (Actual)

165

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Criterios de inclusión:

  1. Diagnóstico de FPI determinado por el investigador principal según las pautas de ATS/ERS/JRS/ALAT.
  2. Puntuación de gravedad de la tos ≥ 4 en CS-NRS (Escala de calificación numérica de la gravedad de la tos) durante el período de selección y el valor inicial.
  3. Antecedentes de tos crónica durante al menos 8 semanas antes de la selección.
  4. SpO2 ≥ 92%, tomada después de al menos 5 minutos en una posición sentada, sin molestias ni estimulación (Saturación de hemoglobina con oxígeno medida por pulsioximetría).
  5. FVC ≥ 40 % del valor teórico normal - Capacidad vital forzada, según lo determinado por espirometría siguiendo las pautas de ATS/ERS.
  6. DLCO ≥ 25 % del valor teórico normal: capacidad de difusión del pulmón para el monóxido de carbono corregida para la hemoglobina, evaluada en las últimas 12 semanas o en el momento de la selección.

Criterio de exclusión:

  1. Actualmente en oxigenoterapia continua durante más de 16 horas a cualquier nivel o administrada por cualquier modalidad. Se permite el uso intermitente de oxígeno de cualquier duración durante un período determinado de 24 horas.
  2. Reflejo de deglución inadecuado evaluado por la capacidad de sorber 3 onzas líquidas (u 89 ml) de agua sin toser ni atragantarse.
  3. Infección del tracto respiratorio superior o inferior en las últimas 8 semanas antes de la visita inicial.
  4. Historia clínica de neumonitis por aspiración.
  5. Diagnóstico de la apnea del sueño.
  6. Antecedentes de trastorno psiquiátrico mayor.
  7. Historial de abuso de sustancias.
  8. Condición médica significativa u otros factores que puedan interferir con la capacidad del sujeto para completar con éxito el estudio.
  9. Sujeto femenino gestante o lactante.
  10. Intolerancia conocida (síntomas gastrointestinales, del sistema nervioso central), hipersensibilidad, alergia a medicamentos después del uso de un fármaco opioide.
  11. El uso de opiáceos está prohibido dentro de los 14 días anteriores a la visita inicial.
  12. El uso de benzodiazepinas está prohibido dentro de los 14 días anteriores a la visita inicial y durante la duración del estudio.
  13. Los inhibidores de la monoaminooxidasa (IMAO), incluidos el azul de metileno (cloruro de metiltioninio) y el antibiótico linezolid, están prohibidos en los 14 días anteriores a la visita inicial y durante la duración del estudio.
  14. Está prohibido el uso de tratamiento para la tos con corticosteroides orales dentro de las 4 semanas anteriores a la visita inicial y durante la duración del estudio.
  15. Está prohibida la exposición a cualquier medicamento en investigación, incluido el placebo, dentro de las 4 semanas anteriores a la visita inicial y durante la duración del estudio.
  16. Los medicamentos recetados como supresores de la tos están prohibidos a menos que estén en una dosis estable 14 días antes de la visita inicial y se espera que permanezcan en esa dosis durante la duración del estudio.
  17. Está prohibido el uso de medicamentos que afectan la neurotransmisión serotoninérgica y que, cuando se usan de forma concomitante con opioides, pueden aumentar el riesgo de síndrome serotoninérgico, a menos que estén en una dosis estable 14 días antes de la visita inicial y se espera que permanezcan en esa dosis durante la duración del estudio. .
  18. Los medicamentos antifibróticos están prohibidos a menos que estén en una dosis estable durante 8 semanas antes de la visita inicial y se espera que permanezcan en esa dosis durante la duración del estudio.
  19. Los inhibidores/inductores fuertes de las isoenzimas P450 están prohibidos a menos que estén en una dosis estable durante 14 días antes de la visita inicial y se espera que permanezcan en esa dosis durante la duración del estudio.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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).
Droga: Nal er
Tabletas orales
Otros nombres:
  • Nalbufina
Droga: Nal er
Tabletas orales
Otros nombres:
  • Nalbufina
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).
Droga: Nal er
Tabletas orales
Otros nombres:
  • Nalbufina
Droga: Nal er
Tabletas orales
Otros nombres:
  • Nalbufina
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).
Droga: Nal er
Tabletas orales
Otros nombres:
  • Nalbufina
Droga: Nal er
Tabletas orales
Otros nombres:
  • Nalbufina
Comparador de placebos: 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).
Droga: Placebo
Tabletas orales

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Relative Change From Baseline in 24-hour Cough Frequency at Week 6
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Relative Change From Baseline in Evaluating Respiratory Symptoms in Idiopathic Pulmonary Fibrosis (E-RS:IPF) Cough Subscale at Week 6
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Trevi Therapeutics

Investigadores

  • Director de estudio: Chief Development Officer, Trevi Therapeutics

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

6 de febrero de 2024

Finalización primaria (Actual)

24 de abril de 2025

Finalización del estudio (Actual)

24 de abril de 2025

Fechas de registro del estudio

Enviado por primera vez

7 de julio de 2023

Primero enviado que cumplió con los criterios de control de calidad

19 de julio de 2023

Publicado por primera vez (Actual)

27 de julio de 2023

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

26 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

2 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • NAL03-202

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

Sí

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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