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Redukcja kaszlu w IPF za pomocą Nalbufiny ER (CORAL)

2 czerwca 2026 zaktualizowane przez: Trevi Therapeutics

Randomizowane, prowadzone metodą podwójnie ślepej próby, kontrolowane placebo, równoległe, 4-ramienne badanie z różnymi dawkami, dotyczące bezpieczeństwa i skuteczności tabletek o przedłużonym uwalnianiu nalbufiny (NAL ER) w leczeniu kaszlu w idiopatycznym włóknieniu płuc (IPF)

Jest to wieloośrodkowe, randomizowane, podwójnie ślepe, kontrolowane placebo, równoległe, 4-ramienne badanie.

Po spełnieniu warunków kwalifikowalności w okresie przesiewowym, uczestnicy zostaną losowo przydzieleni (1:1:1:1) do jednej z czterech grup leczenia.

  • Ramię 1: Placebo
  • Ramię 2: Ramię dawki 27 mg
  • Ramię 3: Ramię dawki 54 mg
  • Ramię 4: ramię dawki 108 mg Każde ramię będzie miareczkowane do ustalonej dawki podczas zaślepionego 2-tygodniowego okresu miareczkowania, po którym nastąpi 4-tygodniowy okres ustalonej dawki przez łącznie 6 tygodni na leku.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

Jest to wieloośrodkowe, randomizowane, podwójnie ślepe, kontrolowane placebo, równoległe, 4-ramienne badanie.

Po spełnieniu warunków kwalifikowalności w okresie przesiewowym, uczestnicy zostaną losowo przydzieleni (1:1:1:1) do jednej z czterech grup leczenia.

  • Ramię 1: Placebo
  • Ramię 2: Ramię dawki 27 mg
  • Ramię 3: Ramię dawki 54 mg
  • Ramię 4: Dawka 108 mg Każde ramię będzie miareczkowane do ustalonej dawki podczas zaślepionego 2-tygodniowego okresu miareczkowania zgodnie z Tabelą: Schemat dawkowania, po którym nastąpi 4-tygodniowy okres ustalonej dawki przez łącznie 6 tygodni na leku.

Osobnicy zostaną odstawieni od badanego leku pod koniec Okresu Ustalonej Dawki i pozostaną po zakończeniu leczenia przez dodatkowe 2 tygodnie.

Jeśli w dowolnym momencie nastąpi trwałe odstawienie badanego produktu, pacjent powinien wrócić na wizyty kontrolne w celu odstawienia i bezpieczeństwa. Następnie skontaktujemy się z nimi telefonicznie w 6. tygodniu w celu zebrania informacji na temat poważnych zdarzeń niepożądanych (SAE) i stanu życiowego.

Niezależna Rada ds. Monitorowania Bezpieczeństwa Danych (DSMB) będzie okresowo przeglądać wybrane dane.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

165

Faza

  • Faza 2

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

Kryteria przyjęcia:

  1. Rozpoznanie IPF określone przez głównego badacza na podstawie wytycznych ATS/ERS/JRS/ALAT.
  2. Ocena ciężkości kaszlu ≥ 4 w CS-NRS (numeryczna skala oceny nasilenia kaszlu) w okresie badania przesiewowego i linii podstawowej.
  3. Historia przewlekłego kaszlu przez co najmniej 8 tygodni przed badaniem przesiewowym.
  4. SpO2 ≥ 92%, mierzone po co najmniej 5 minutach w pozycji siedzącej, niezakłóconej i niestymulowanej (nasycenie hemoglobiny tlenem mierzone za pomocą pulsoksymetrii).
  5. FVC ≥ 40% wartości należnej normy — natężona pojemność życiowa, określona za pomocą spirometrii zgodnie z wytycznymi ATS/ERS.
  6. DLCO ≥ 25% wartości należnej normy — zdolność dyfuzyjna płuc dla tlenku węgla skorygowana o hemoglobinę, oceniana w ciągu ostatnich 12 tygodni lub w czasie badania przesiewowego.

Kryteria wyłączenia:

  1. Obecnie w ciągłej terapii tlenowej przez ponad 16 godzin na dowolnym poziomie lub w dowolnej formie. Dozwolone jest przerywane stosowanie tlenu przez dowolny czas w dowolnym okresie 24-godzinnym.
  2. Niewystarczający odruch połykania oceniany na podstawie zdolności wypicia 3 uncji płynu (lub 89 ml) wody bez kaszlu lub krztuszenia się.
  3. Infekcja górnych lub dolnych dróg oddechowych w ciągu ostatnich 8 tygodni przed wizytą wyjściową.
  4. Historia kliniczna zachłystowego zapalenia płuc.
  5. Diagnostyka bezdechu sennego.
  6. Historia poważnych zaburzeń psychicznych.
  7. Historia nadużywania substancji.
  8. Poważny stan zdrowia lub inne czynniki, które mogą zakłócać zdolność uczestnika do pomyślnego ukończenia badania.
  9. Kobieta w ciąży lub karmiąca piersią.
  10. Znana nietolerancja (objawy żołądkowo-jelitowe, ze strony ośrodkowego układu nerwowego), nadwrażliwość, alergia na lek po zastosowaniu leku opioidowego.
  11. Stosowanie opiatów jest zabronione w ciągu 14 dni przed wizytą wyjściową.
  12. Stosowanie benzodiazepin jest zabronione na 14 dni przed wizytą wyjściową i na czas trwania badania.
  13. Inhibitory monoaminooksydazy (IMAO), w tym błękit metylenowy (chlorek metylotioniniowy) i antybiotyk linezolid, są zabronione na 14 dni przed wizytą wyjściową i na czas trwania badania.
  14. Stosowanie doustnych kortykosteroidów w leczeniu kaszlu jest zabronione w ciągu 4 tygodni przed wizytą wyjściową i na czas trwania badania.
  15. Narażenie na jakikolwiek badany lek, w tym placebo, jest zabronione w ciągu 4 tygodni przed wizytą wyjściową i przez cały czas trwania badania.
  16. Leki przepisywane jako środki przeciwkaszlowe są zabronione, chyba że w stabilnej dawce 14 dni przed wizytą wyjściową i oczekuje się, że pozostaną na tej dawce przez cały czas trwania badania.
  17. Stosowanie leków, które wpływają na przekaźnictwo serotoninergiczne i które stosowane jednocześnie z opioidami mogą zwiększać ryzyko wystąpienia zespołu serotoninowego, są zabronione, chyba że otrzymują stabilną dawkę 14 dni przed wizytą wyjściową i oczekuje się, że pozostaną na tej dawce przez cały czas trwania badania .
  18. Leki przeciwzwłóknieniowe są zabronione, chyba że są w stabilnej dawce przez 8 tygodni przed wizytą wyjściową i oczekuje się, że pozostaną na tej dawce przez cały czas trwania badania.
  19. Silne inhibitory/induktory izozymów P450 są zabronione, chyba że są przyjmowane w stabilnej dawce przez 14 dni przed wizytą wyjściową i oczekuje się, że pozostaną na tej dawce przez cały czas trwania badania.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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).
Lek: Nal er
Tabletki doustne
Inne nazwy:
  • Nalbufina
Lek: Nal er
Tabletki doustne
Inne nazwy:
  • Nalbufina
Eksperymentalny: 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).
Lek: Nal er
Tabletki doustne
Inne nazwy:
  • Nalbufina
Lek: Nal er
Tabletki doustne
Inne nazwy:
  • Nalbufina
Eksperymentalny: 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).
Lek: Nal er
Tabletki doustne
Inne nazwy:
  • Nalbufina
Lek: Nal er
Tabletki doustne
Inne nazwy:
  • Nalbufina
Komparator 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).
Lek: Placebo
Tabletki doustne

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Relative Change From Baseline in 24-hour Cough Frequency at Week 6
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Relative Change From Baseline in Evaluating Respiratory Symptoms in Idiopathic Pulmonary Fibrosis (E-RS:IPF) Cough Subscale at Week 6
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Trevi Therapeutics

Śledczy

  • Dyrektor Studium: Chief Development Officer, Trevi Therapeutics

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

6 lutego 2024

Zakończenie podstawowe (Rzeczywisty)

24 kwietnia 2025

Ukończenie studiów (Rzeczywisty)

24 kwietnia 2025

Daty rejestracji na studia

Pierwszy przesłany

7 lipca 2023

Pierwszy przesłany, który spełnia kryteria kontroli jakości

19 lipca 2023

Pierwszy wysłany (Rzeczywisty)

27 lipca 2023

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

26 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

2 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • NAL03-202

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Tak

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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