Tämä sivu käännettiin automaattisesti, eikä käännösten tarkkuutta voida taata. Katso englanninkielinen versio lähdetekstiä varten.

Yskän vähentäminen IPF:ssä Nalbuphine ER:n avulla (CORAL)

tiistai 2. kesäkuuta 2026 päivittänyt: Trevi Therapeutics

Satunnaistettu, kaksoissokkoutettu, lumekontrolloitu, rinnakkainen, 4-haarainen annosaluetutkimus nalbufiinin pitkitetysti vapauttavien tablettien (NAL ER) turvallisuudesta ja tehokkuudesta yskän hoidossa idiopaattisessa keuhkofibroosissa (IPF)

Tämä on monikeskustutkimus, satunnaistettu, kaksoissokkoutettu, lumekontrolloitu, rinnakkainen, 4-haarainen tutkimus.

Kun seulontajakson aikana kelpoisuus on saavutettu, koehenkilöt satunnaistetaan (1:1:1:1) johonkin neljästä hoitohaarasta.

  • Käsivarsi 1: Placebo
  • Varsi 2: 27 mg:n annosvarsi
  • Varsi 3: 54 mg:n annosvarsi
  • Käsivarsi 4: 108 mg:n annosvarsi Kukin käsivarsi titrataan kiinteään annokseen 2 viikon titrausjakson aikana, jota seuraa 4 viikon kiinteän annoksen jakso yhteensä 6 viikon ajan.

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

Tämä on monikeskustutkimus, satunnaistettu, kaksoissokkoutettu, lumekontrolloitu, rinnakkainen, 4-haarainen tutkimus.

Kun seulontajakson aikana kelpoisuus on saavutettu, koehenkilöt satunnaistetaan (1:1:1:1) johonkin neljästä hoitohaarasta.

  • Käsivarsi 1: Placebo
  • Varsi 2: 27 mg:n annosvarsi
  • Varsi 3: 54 mg:n annosvarsi
  • Käsivarsi 4: 108 mg:n annostusvarsi Kukin käsivarsi titrataan kiinteään annokseen 2 viikon sokkoutetun titrausjakson aikana taulukon: Annostuskaavio mukaisesti, jota seuraa 4 viikon kiinteä annosjakso yhteensä 6 viikon ajan.

Koehenkilöiltä poistetaan tutkimuslääke kiinteän annoksen jakson lopussa ja hoitoa seurataan vielä 2 viikon ajan.

Jos tutkimusvalmisteen käyttö lopetetaan pysyvästi milloin tahansa, potilaan tulee palata keskeytys- ja turvallisuusseurantakäyntejä varten. Heihin otetaan sitten yhteyttä viikolla 6 puhelimitse kerätäkseen tietoja vakavista haittatapahtumista (SAE) ja elintilasta.

Riippumaton Data Safety Monitoring Board (DSMB) tarkistaa valitut tiedot säännöllisesti.

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

165

Vaihe

  • Vaihe 2

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

  • Alankomaat
      • 's-Hertogenbosch, Alankomaat, 5223 GZ
        • Jeroen Bosch Ziekenhuis
      • Groningen, Alankomaat, 9728 NT
        • Martini ziekenhuis
      • Rotterdam, Alankomaat, 3015 GD
        • Erasmus Medisch Centrum 1
      • The Hague, Alankomaat, 2512 VA
        • HMC (Haaglanden Medisch Centrum) Bronovo
  • 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
        • 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
  • Espanja
      • Barcelona, Espanja, 08907
        • Hospital Universitari de Bellvitge
      • Barcelona, Espanja, 08017
        • Clinica Mi Tres Torres Barcelona
      • Madrid, Espanja, 28010
        • Hospital La Milagrosa
      • Santander, Espanja, 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
  • 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.
  • Puola
      • Gdansk, Puola, 80-214
        • Uniwersyteckie Centrum Kliniczne (UCK)
      • Lodz, Puola, 90-153
        • Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego
      • Olsztyn, Puola, 10-357
        • Warminsko Mazurskie Centrum Chorob Pluc w Olsztynie
      • Szczecin, Puola, 70-891
        • Samodzielny Publiczny Wojewodzki Szpital Zespolony w Szczecinie
  • Saksa
      • Essen, Saksa, 45239
        • Universitatsklinik Ruhrlandklinik, Westdeutsches Lungenzentrum
      • Frankfurt am Main, Saksa, 60596
        • IKF Institut fuer klinische Forschung Frankfurt
      • Hanover, Saksa, 30625
        • Medizinische Hochschule Hannover, Hannover Medical School
      • Leipzig, Saksa, 04103
        • University Hospital of Leipzig
      • Mainz, Saksa, 55131
        • University Medical Center of Johannes Gutenberg-University Mainz
      • Mainz, Saksa, 55128
        • IKF Pneumologie Mainz, Helix Medical Excellence Center Mainz
      • Solingen, Saksa, 42699
        • Krankenhaus Bethanien
  • Turkki (Türkiye)
      • Ankara, Turkki (Türkiye), 06010
        • Gulhane Askeri Tip Akademisi (GATA) - Gulhane Askeri Tip Fakultesi (Gulhane Military Medical Academy and Medical School)
      • Antalya, Turkki (Türkiye), 7070
        • Akdeniz University Faculty of Medicine
      • Istanbul, Turkki (Türkiye), 34854
        • Sureyyapasa Gogus Hastaliklari ve Gogus Cerrahisi Egitim ve Arastirma Hastanesi
      • Izmir, Turkki (Türkiye), 35100
        • Ege University Medical Faculty
      • Konya, Turkki (Türkiye), 42130
        • Selcuk Universty Medical Faculty
      • Çanakkale, Turkki (Türkiye), 17020
        • Canakkale Onsekiz Mart Universitesi (COMU) - Tip Fakultesi Hastanesi
  • Yhdistynyt kuningaskunta
      • Birmingham, Yhdistynyt kuningaskunta, B15 2GW
        • Queen Elizabeth Hospital Birmingham - University Hospitals Birmingham NHS Foundation Trust
      • Cambridge, Yhdistynyt kuningaskunta, CB2 0AY
        • Royal Papworth Hospital
      • Cottingham, Yhdistynyt kuningaskunta, HU16 5JQ
        • Hull and East Yorkshire - Castle Hill Hospital
      • Edinburgh, Yhdistynyt kuningaskunta, EH16 4SA
        • Royal Infirmary of Edinburgh
      • London, Yhdistynyt kuningaskunta, SW3 6NP
        • Royal Brompton Hospital
      • London, Yhdistynyt kuningaskunta, NW1 2PG
        • University College London
      • Londonderry, Yhdistynyt kuningaskunta, BT47 6SB
        • Altnagelvin Area Hospital
      • Manchester, Yhdistynyt kuningaskunta, M23 9LT
        • Wythenshawe Hospital
      • Norwich, Yhdistynyt kuningaskunta, NR4 7UY
        • Norfolk and Norwich University Hospital
      • Nottingham, Yhdistynyt kuningaskunta, NG5 1PB
        • Nottingham City Hospital
      • Oxford, Yhdistynyt kuningaskunta, OX3 7LE
        • Churchill Hospital
      • Portadown, Yhdistynyt kuningaskunta, BT63 5QQ
        • Southern Health & Social Care Trust, Craigavon Area Hospital
      • Southampton, Yhdistynyt kuningaskunta, SO16 6YD
        • Southampton General Hospital

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

  • Aikuinen
  • Vanhempi Aikuinen

Hyväksyy terveitä vapaaehtoisia

Ei

Kuvaus

Sisällyttämiskriteerit:

  1. Päätutkijan määrittämä IPF:n diagnoosi ATS/ERS/JRS/ALAT-ohjeiden perusteella.
  2. Yskän vakavuuspisteet ≥ 4 CS-NRS:ssä (yskän vaikeusasteikossa) seulontajakson aikana ja lähtötilanteessa.
  3. Krooninen yskä vähintään 8 viikkoa ennen seulontaa.
  4. SpO2 ≥ 92 % otettuna vähintään 5 minuutin istuma-asennon jälkeen, häiriintymättä ja stimuloimatta (Hemoglobiinin kyllästyminen hapen kanssa pulssioksimetrialla mitattuna).
  5. FVC ≥ 40 % ennustettu normaalista - Forced Vital Capacity, määritettynä spirometrialla noudattaen ATS/ERS-ohjeita.
  6. DLCO ≥ 25 % ennustettu normaalista - Keuhkojen diffuusiokyky hiilimonoksidin suhteen korjattu hemoglobiinin suhteen, arvioitu viimeisen 12 viikon aikana tai seulonnan aikana.

Poissulkemiskriteerit:

  1. Tällä hetkellä jatkuvassa happihoidossa yli 16 tuntia millä tahansa tasolla tai toimitetaan millä tahansa tavalla. Ajoittainen hapen käyttö minkä tahansa keston ajan minkä tahansa 24 tunnin ajanjakson aikana on sallittua.
  2. Riittämätön nielemisrefleksi mitattuna kyvyllä siemailla 3 neste unssia (tai 89 ml) vettä ilman yskimistä tai tukehtumista.
  3. Ylempien tai alempien hengitysteiden infektio viimeisen 8 viikon aikana ennen peruskäyntiä.
  4. Aspiraatiokeuhkotulehduksen kliininen historia.
  5. Uniapnean diagnoosi.
  6. Vakavan psykiatrisen häiriön historia.
  7. Päihteiden väärinkäytön historia.
  8. Merkittävä sairaus tai muut tekijät, jotka voivat häiritä tutkittavan kykyä suorittaa tutkimus onnistuneesti.
  9. Raskaana oleva tai imettävä nainen.
  10. Tunnettu intoleranssi (ruoansulatuskanavan, keskushermoston oireet), yliherkkyys, lääkeaineallergia opioidilääkkeen käytön jälkeen.
  11. Opiaattien käyttö on kielletty 14 päivää ennen peruskäyntiä.
  12. Bentsodiatsepiinien käyttö on kielletty 14 päivää ennen lähtökohtaista käyntiä ja tutkimuksen ajan.
  13. Monoamiinioksidaasin estäjät (MAO:t), mukaan lukien metyleenisininen (metyylitioniniumkloridi) ja antibiootti linetsolidi, ovat kiellettyjä 14 päivää ennen lähtötilannekäyntiä ja tutkimuksen ajan.
  14. Suun kautta otettavan kortikosteroidi-yskänhoidon käyttö on kielletty 4 viikkoa ennen lähtökohtaista käyntiä ja tutkimuksen ajan.
  15. Altistuminen millekään tutkittavalle lääkkeelle, mukaan lukien lumelääke, on kielletty 4 viikon aikana ennen peruskäyntiä ja tutkimuksen ajan.
  16. Yskänlääkkeiksi määrätyt lääkkeet ovat kiellettyjä, elleivät ne ole vakaalla annoksella 14 päivää ennen peruskäyntiä, ja niiden odotetaan pysyvän tällä annoksella tutkimuksen ajan.
  17. Sellaisten lääkkeiden käyttö, jotka vaikuttavat serotonergiseen neurotransmissioon ja joita käytetään samanaikaisesti opioidien kanssa, jotka voivat lisätä serotoniinioireyhtymän riskiä, ​​on kiellettyä, ellei lääkkeellä ole vakaa annos 14 päivää ennen lähtökohtaista käyntiä ja joiden odotetaan pysyvän tällä annoksella koko tutkimuksen ajan. .
  18. Antifibroottiset lääkkeet ovat kiellettyjä, elleivät ne ole vakaalla annoksella 8 viikkoa ennen peruskäyntiä, ja niiden odotetaan pysyvän tällä annoksella tutkimuksen ajan.
  19. P450-isotsyymien voimakkaat inhibiittorit/indusoijat ovat kiellettyjä, elleivät ne ole vakaalla annoksella 14 päivää ennen lähtökohtaista käyntiä, ja niiden odotetaan pysyvän tällä annoksella koko tutkimuksen ajan.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Kaksinkertainen

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: 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).
Lääke: Epämuotoinen
Oraaliset tabletit
Muut nimet:
  • Nalbufiini
Lääke: Epämuotoinen
Oraaliset tabletit
Muut nimet:
  • Nalbufiini
Kokeellinen: 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).
Lääke: Epämuotoinen
Oraaliset tabletit
Muut nimet:
  • Nalbufiini
Lääke: Epämuotoinen
Oraaliset tabletit
Muut nimet:
  • Nalbufiini
Kokeellinen: 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).
Lääke: Epämuotoinen
Oraaliset tabletit
Muut nimet:
  • Nalbufiini
Lääke: Epämuotoinen
Oraaliset tabletit
Muut nimet:
  • Nalbufiini
Placebo Comparator: 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).
Lääke: Plasebo
Suun kautta otettavat tabletit

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Relative Change From Baseline in 24-hour Cough Frequency at Week 6
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Relative Change From Baseline in Evaluating Respiratory Symptoms in Idiopathic Pulmonary Fibrosis (E-RS:IPF) Cough Subscale at Week 6
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Trevi Therapeutics

Tutkijat

  • Opintojohtaja: Chief Development Officer, Trevi Therapeutics

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

Yleiset julkaisut

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Tiistai 6. helmikuuta 2024

Ensisijainen valmistuminen (Todellinen)

Torstai 24. huhtikuuta 2025

Opintojen valmistuminen (Todellinen)

Torstai 24. huhtikuuta 2025

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Perjantai 7. heinäkuuta 2023

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Keskiviikko 19. heinäkuuta 2023

Ensimmäinen Lähetetty (Todellinen)

Torstai 27. heinäkuuta 2023

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Perjantai 26. kesäkuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Tiistai 2. kesäkuuta 2026

Viimeksi vahvistettu

Maanantai 1. kesäkuuta 2026

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • NAL03-202

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

EI

Lääke- ja laitetiedot, tutkimusasiakirjat

Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta

Joo

Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta

Ei

Yhdysvalloissa valmistettu ja sieltä viety tuote

Joo

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

Tilaa