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Уменьшение кашля при ИЛФ с помощью налбуфина ER (CORAL)

2 июня 2026 г. обновлено: Trevi Therapeutics

Рандомизированное двойное слепое плацебо-контролируемое параллельное исследование с ранжированием доз в 4 группах безопасности и эффективности таблеток с пролонгированным высвобождением налбуфина (NAL ER) для лечения кашля при идиопатическом легочном фиброзе (IPF)

Это многоцентровое рандомизированное двойное слепое плацебо-контролируемое параллельное исследование с 4 группами.

После соответствия требованиям в течение периода скрининга субъекты будут рандомизированы (1:1:1:1) в одну из четырех групп лечения.

  • Группа 1: плацебо
  • Группа 2: группа с дозой 27 мг
  • Группа 3: группа с дозой 54 мг
  • Группа 4: Группа с дозой 108 мг Каждая группа будет титроваться до фиксированной дозы в течение слепого 2-недельного периода титрования, за которым следует 4-недельный период фиксированной дозы, в общей сложности 6 недель приема препарата.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Подробное описание

Это многоцентровое рандомизированное двойное слепое плацебо-контролируемое параллельное исследование с 4 группами.

После соответствия требованиям в течение периода скрининга субъекты будут рандомизированы (1:1:1:1) в одну из четырех групп лечения.

  • Группа 1: плацебо
  • Группа 2: группа с дозой 27 мг
  • Группа 3: группа с дозой 54 мг
  • Группа 4: группа с дозой 108 мг Каждая группа будет титроваться до своей фиксированной дозы в течение слепого 2-недельного периода титрования в соответствии с таблицей: схема дозирования, за которым следует 4-недельный период фиксированной дозы, в общей сложности 6 недель приема препарата.

Субъекты будут отменять исследуемый препарат в конце периода фиксированной дозы, а затем продолжать лечение в течение дополнительных 2 недель.

Если в любое время происходит окончательное прекращение приема исследуемого продукта, субъект должен вернуться для последующих посещений по вопросам прекращения и безопасности. Затем на 6-й неделе с ними свяжутся по телефону для сбора информации о серьезных нежелательных явлениях (СНЯ) и жизненном статусе.

Независимый совет по мониторингу безопасности данных (DSMB) будет периодически проверять выбранные данные.

Тип исследования

Интервенционный

Регистрация (Действительный)

165

Фаза

  • Фаза 2

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

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

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Нет

Описание

Критерии включения:

  1. Диагноз ИЛФ, установленный главным исследователем на основе рекомендаций ATS/ERS/JRS/ALAT.
  2. Оценка тяжести кашля ≥ 4 по шкале CS-NRS (числовая шкала оценки тяжести кашля) в период скрининга и на исходном уровне.
  3. История хронического кашля в течение как минимум 8 недель до скрининга.
  4. SpO2 ≥ 92%, измеренное не менее чем через 5 минут в положении сидя, в покое и без стимуляции (насыщение гемоглобина кислородом, измеренное с помощью пульсоксиметрии).
  5. ФЖЕЛ ≥ 40% от нормы - форсированная жизненная емкость легких, определенная с помощью спирометрии в соответствии с рекомендациями ATS/ERS.
  6. DLCO ≥ 25% от нормы - Диффузионная способность легких по моноксиду углерода с поправкой на гемоглобин, оцененная в течение последних 12 недель или во время скрининга.

Критерий исключения:

  1. В настоящее время проводится непрерывная оксигенотерапия более 16 часов на любом уровне или любым способом. Допускается прерывистое использование кислорода любой продолжительности в течение любого заданного 24-часового периода.
  2. Недостаточный глотательный рефлекс, оцениваемый по способности выпить 3 жидких унции (или 89 мл) воды без кашля или удушья.
  3. Инфекция верхних или нижних дыхательных путей за последние 8 недель до исходного визита.
  4. Клиника аспирационного пневмонита.
  5. Диагностика апноэ сна.
  6. История серьезного психического расстройства.
  7. История злоупотребления психоактивными веществами.
  8. Серьезное заболевание или другие факторы, которые могут помешать успешному завершению исследования субъектом.
  9. Беременная или кормящая женщина.
  10. Известная непереносимость (со стороны желудочно-кишечного тракта, центральной нервной системы), гиперчувствительность, лекарственная аллергия после применения опиоидного препарата.
  11. Употребление опиатов запрещено в течение 14 дней до исходного визита.
  12. Использование бензодиазепинов запрещено в течение 14 дней до исходного визита и на время исследования.
  13. Ингибиторы моноаминоксидазы (ИМАО), включая метиленовый синий (хлорид метилтиониния) и антибиотик линезолид, запрещены в течение 14 дней до исходного визита и на время исследования.
  14. Использование пероральных кортикостероидов для лечения кашля запрещено в течение 4 недель до исходного визита и на время исследования.
  15. Воздействие любых исследуемых препаратов, включая плацебо, запрещено в течение 4 недель до исходного визита и на протяжении всего исследования.
  16. Лекарства, назначаемые в качестве средств от кашля, запрещены, за исключением случаев, когда они принимают стабильную дозу за 14 дней до исходного визита, и ожидается, что эта доза останется на протяжении всего исследования.
  17. Использование лекарств, которые влияют на серотонинергическую нейротрансмиссию и которые при одновременном применении с опиоидами могут увеличить риск серотонинового синдрома, запрещено, если только они не принимают стабильную дозу за 14 дней до исходного визита, и ожидается, что эта доза останется на протяжении всего исследования. .
  18. Противофиброзные препараты запрещены, если только они не принимают стабильную дозу в течение 8 недель до исходного визита, и ожидается, что эта доза останется на протяжении всего исследования.
  19. Сильные ингибиторы/индукторы изоферментов P450 запрещены, если только они не принимают стабильную дозу в течение 14 дней до исходного визита, и ожидается, что эта доза останется на протяжении всего исследования.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Двойной

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: 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).
Лекарство: Нал эр
Пероральные таблетки
Другие имена:
  • Налбуфин
Лекарство: Нал эр
Пероральные таблетки
Другие имена:
  • Налбуфин
Экспериментальный: 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).
Лекарство: Нал эр
Пероральные таблетки
Другие имена:
  • Налбуфин
Лекарство: Нал эр
Пероральные таблетки
Другие имена:
  • Налбуфин
Экспериментальный: 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).
Лекарство: Нал эр
Пероральные таблетки
Другие имена:
  • Налбуфин
Лекарство: Нал эр
Пероральные таблетки
Другие имена:
  • Налбуфин
Плацебо Компаратор: 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).
Лекарство: Плацебо
Оральные таблетки

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Relative Change From Baseline in 24-hour Cough Frequency at Week 6
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Relative Change From Baseline in Evaluating Respiratory Symptoms in Idiopathic Pulmonary Fibrosis (E-RS:IPF) Cough Subscale at Week 6
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Соавторы и исследователи

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Спонсор

Trevi Therapeutics

Следователи

  • Директор по исследованиям: Chief Development Officer, Trevi Therapeutics

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

6 февраля 2024 г.

Первичное завершение (Действительный)

24 апреля 2025 г.

Завершение исследования (Действительный)

24 апреля 2025 г.

Даты регистрации исследования

Первый отправленный

7 июля 2023 г.

Впервые представлено, что соответствует критериям контроля качества

19 июля 2023 г.

Первый опубликованный (Действительный)

27 июля 2023 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

26 июня 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

2 июня 2026 г.

Последняя проверка

1 июня 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • NAL03-202

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Да

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

продукт, произведенный в США и экспортированный из США.

Да

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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