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ナルブフィン ER による IPF における咳の軽減 (CORAL)

2026年6月2日 更新者：Trevi Therapeutics

特発性肺線維症（IPF）における咳の治療におけるナルブフィン徐放性錠剤（NAL ER）の安全性と有効性に関するランダム化二重盲検プラセボ対照並行4群用量範囲研究

これは、多施設無作為化、二重盲検、プラセボ対照、並行 4 群研究です。

スクリーニング期間中に適格性を満たした後、被験者は 4 つの治療群のいずれかにランダムに (1:1:1:1) 割り当てられます。

  • アーム 1: プラセボ
  • アーム 2: 27 mg 用量アーム
  • アーム 3: 54 mg 用量アーム
  • アーム 4: 108 mg 用量アーム 各アームは、2 週間の盲検滴定期間中に固定用量に漸増され、その後 4 週間の固定用量期間が続き、合計 6 週間薬物が投与されます。

調査の概要

状態

完了

条件

介入・治療

詳細な説明

これは、多施設無作為化、二重盲検、プラセボ対照、並行 4 群研究です。

スクリーニング期間中に適格性を満たした後、被験者は 4 つの治療群のいずれかにランダムに (1:1:1:1) 割り当てられます。

  • アーム 1: プラセボ
  • アーム 2: 27 mg 用量アーム
  • アーム 3: 54 mg 用量アーム
  • アーム 4: 108 mg 用量アーム 各アームは、表: 投与スキームに従って盲検の 2 週間の滴定期間中に固定用量に滴定され、その後、合計 6 週間の薬物投与の 4 週間の固定用量期間が続きます。

被験者は固定用量期間の終わりに治験薬を中止し、さらに２週間治療を中止する。

治験製品の永久中止が生じた場合はいつでも、被験者は中止と安全性のフォローアップのために再来院する必要があります。 その後、重篤な有害事象 (SAE) および生命状態に関する情報を収集するために、6 週目に電話で連絡されます。

独立したデータ安全監視委員会 (DSMB) が、選択されたデータを定期的にレビューします。

研究の種類

介入

入学 (実際)

165

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

包含基準:

  1. ATS/ERS/JRS/ALAT ガイドラインに基づいて主任研究者によって決定された IPF の診断。
  2. スクリーニング期間およびベースライン中のCS-NRS（咳重症度数値評価スケール）で咳重症度スコアが4以上。
  3. スクリーニング前の少なくとも8週間にわたる慢性咳嗽の病歴。
  4. SpO2 ≥ 92%、座位で少なくとも 5 分間、邪魔されず刺激を受けずに測定した後 (パルスオキシメトリーで測定したヘモグロビンの酸素飽和度)。
  5. ATS/ERS ガイドラインに準拠した肺活量測定によって決定される、正常値の予測値の FVC ≥ 努力肺活量。
  6. DLCO ≧ 25% が正常と予測される - 過去 12 週間以内またはスクリーニング時に評価された、ヘモグロビンについて補正された一酸化炭素に対する肺の拡散能力。

除外基準:

  1. 現在、任意のレベルまたは任意のモダリティで 16 時間を超える連続酸素療法を受けている。 任意の 24 時間にわたる断続的な酸素の使用は、任意の期間にわたって許可されます。
  2. 嚥下反射が不十分で、咳や窒息を伴うことなく 3 液量オンス (または 89 mL) の水を飲む能力によって評価されます。
  3. -ベースライン訪問前の過去8週間における上気道または下気道感染症。
  4. 誤嚥性肺炎の臨床歴。
  5. 睡眠時無呼吸症候群の診断。
  6. 重大な精神障害の病歴。
  7. 薬物乱用の歴史。
  8. 被験者が研究を正常に完了する能力を妨げる可能性のある重大な病状またはその他の要因。
  9. 妊娠中または授乳中の女性被験者。
  10. 既知の不耐症（胃腸、中枢神経系の症状）、過敏症、オピオイド薬使用後の薬物アレルギー。
  11. ベースライン訪問前の 14 日間はアヘン剤の使用が禁止されています。
  12. ベンゾジアゼピンの使用は、ベースライン訪問前の 14 日間および研究期間中禁止されます。
  13. メチレンブルー（塩化メチルチオニニウム）や抗生物質リネゾリドを含むモノアミンオキシダーゼ阻害剤（MAOI）は、ベースライン来院前の14日間および研究期間中は禁止されています。
  14. 経口コルチコステロイド咳嗽治療の使用は、ベースライン訪問前の 4 週間以内および研究期間中禁止されます。
  15. プラセボを含むいかなる治験薬への曝露も、ベースライン訪問前の 4 週間以内および研究期間中禁止されています。
  16. 咳止め剤として処方された薬剤は、ベースライン訪問の 14 日前に安定した用量で、研究期間中その用量を維持することが予想される場合を除き、禁止されています。
  17. セロトニン作動性神経伝達に影響を及ぼし、オピオイドと併用するとセロトニン症候群のリスクを高める可能性のある薬剤の使用は、ベースライン来院の14日前に安定用量であり、研究期間中その用量を継続することが予想される場合を除き、禁止されています。 。
  18. 抗線維症薬の投与は、ベースライン来院前の 8 週間にわたって安定した用量を使用しない限り禁止されており、研究期間中はその用量を継続することが予想されます。
  19. P450 アイソザイムの強力な阻害剤/誘導剤は、ベースライン訪問前の 14 日間安定した用量を使用し、研究期間中その用量を継続することが予想される場合を除き、禁止されています。

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的：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).
薬：Nal er
経口錠剤
他の名前：
  • ナルブフィン
薬：Nal er
経口錠剤
他の名前：
  • ナルブフィン
実験的：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).
薬：Nal er
経口錠剤
他の名前：
  • ナルブフィン
薬：Nal er
経口錠剤
他の名前：
  • ナルブフィン
実験的：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).
薬：Nal er
経口錠剤
他の名前：
  • ナルブフィン
薬：Nal er
経口錠剤
他の名前：
  • ナルブフィン
プラセボコンパレーター：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).
薬：プラセボ
経口錠剤

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Relative Change From Baseline in 24-hour Cough Frequency at Week 6
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Relative Change From Baseline in Evaluating Respiratory Symptoms in Idiopathic Pulmonary Fibrosis (E-RS:IPF) Cough Subscale at Week 6
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

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スポンサー

Trevi Therapeutics

捜査官

  • スタディディレクター：Chief Development Officer、Trevi Therapeutics

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研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2024年2月6日

一次修了 (実際)

2025年4月24日

研究の完了 (実際)

2025年4月24日

試験登録日

最初に提出

2023年7月7日

QC基準を満たした最初の提出物

2023年7月19日

最初の投稿 (実際)

2023年7月27日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月26日

QC基準を満たした最後の更新が送信されました

2026年6月2日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • NAL03-202

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個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

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米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

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