The Effect of Nalbuphine Extended-Release (NAL ER) on Cough in Participants With Refractory Chronic Cough (RCC)

Официальное название

A Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Efficacy and Safety of Nalbuphine Extended-Release Tablets for the Treatment of Participants With Refractory Chronic Cough

Обзор

The purpose of this study is to evaluate the efficacy and safety of Nalbuphine ER Extended-release tablets for the treatment of participants with RCC.

Вмешательства

• Препарат NAL ER
  Oral tablets
• Препарат Placebo
  Oral tablets

Первичные конечные точки

• Relative Change From Baseline in 24-hour Cough Frequency at Week 6 [Срок оценки: Baseline, Week 6]

Вторичные конечные точки (12)

• Relative Change From Baseline in 24-hour Cough Frequency [Срок оценки: Baseline up to Week 6]
• Percentage of Participants Achieving ≥30%, ≥50% and ≥75% Reduction in 24-hour Cough Frequency [Срок оценки: Baseline up to Week 6]
• Change From Baseline in Patient Reported Cough Frequency (PR-CF) [Срок оценки: Baseline up to Week 6]
• Change From Baseline in Cough Severity Visual Analog Scale (CS-VAS) [Срок оценки: Baseline up to Week 6]
• Percentage of Participants Achieving a 30 Millimeter (mm) Improvement in CS-VAS Total Score [Срок оценки: Baseline up to Week 6]
• Change From Baseline in Cough Severity Numerical Rating Scale (CS-NRS) [Срок оценки: Baseline up to Week 6]
• Change From Baseline in McMaster Cough Severity Questionnaire (MCSQ) Total Score [Срок оценки: Baseline up to Week 6]
• Change From Baseline in MCSQ Domains (Intensity and Frequency) [Срок оценки: Baseline up to Week 6]
• Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score at Week 6 [Срок оценки: Baseline, Week 6]
• Change From Baseline in Each LCQ Domain Score (Physical, Psychological, Social) at Week 6 [Срок оценки: Baseline, Week 6]
• Percentage of Participants Achieving a 1.3- Point Increase From Baseline in LCQ Total Score at Week 6 [Срок оценки: Baseline, Week 6]
• Relative Change From Baseline in Awake Cough Frequency [Срок оценки: Baseline up to Week 6]

Критерии участия

Критерии включения

• Meets society guideline-based criteria for a diagnosis of RCC defined as:

• Insufficient improvement in cough after treatment for any identified cough-associated conditions.
• Unexplained cough for which an underlying condition has not been determined despite adequate investigation with diagnostic tests and trials of therapy.
• Persistent and chronic cough for at least one year prior to Screening.
• Chest computed tomography (CT) or chest radiograph of the thorax performed within the last 24 months and after the onset of chronic cough OR the procedure completed by the Investigator during the Screening period, that does not show any abnormality considered to be significantly contributing to the RCC in the opinion of the Principal Investigator.
• 24-hour objective cough frequency ≥10 coughs/hour based on VitaloJAK® cough monitor recording performed during the Screening and Placebo Run-in Periods as well as a minimum recording duration of 20 hours suitable for analysis during the placebo Run-in assessment.
• Forced expiratory volume in 1 second (FEV1) /forced vital capacity (FVC) ratio ≥ 60% as determined by spirometry adhering to American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines.

Критерии исключения

• Clinical diagnosis of sleep apnea and/or use of continuous positive airway pressure (CPAP).
• Upper or lower respiratory tract infection or change in pulmonary status in the 4 weeks prior to the Screening visit or during the Screening or PBO Run-in periods.
• History of bronchiectasis, chronic obstructive pulmonary disease (COPD) or idiopathic pulmonary fibrosis (IPF), or other significant respiratory disorder that might affect cough.
• History of uncontrolled asthma defined as one of the following:

• ≥1 clinically significant exacerbation in the last 6 months, OR
• ≥2 clinically significant exacerbations in the past 12 months (a clinically significant asthma exacerbation is defined as requiring the use of systemic corticosteroids).
• Current smoker or vaper or current use of tobacco smoke, cannabis smoke, or nicotine vaper.
• Individuals who have stopped smoking or vaping within the past 6 months, or those with >20 pack-year smoking history.
• Current active tuberculosis or nontuberculous mycobacterial infection, a history of latent untreated tuberculosis, or a history of incompletely treated tuberculosis.
• Speech therapy/physiotherapy for RCC starting within 4 weeks of Baseline or during the study. Speech therapy/physiotherapy is acceptable if the participant has started the therapy more than 4 weeks prior to the Baseline visit AND plans to continue the therapy through the Titration and Fixed-dose Treatment Period.
• Known intolerance \[gastrointestinal, central nervous system (CNS) symptoms\], hypersensitivity, or drug allergy considered to be related to an opioid drug or known hypersensitivity to nalbuphine or to NAL ER excipients.

Note: Other protocol-defined inclusion/exclusion criteria may apply.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Канада · 5 центров

• BLC Clinical Research — Burlington
• Diex Recherche - Quebec — Québec
• Clinique Specialisee En Allergie De La Capitale — Québec
• Centre D'Investigation Clinique Mauricie Inc (CIC Mauricie) — Trois-Rivières
• Diex Recherche-Victoriaville — Victoriaville

Идентификаторы

NCT: NCT07671924 · NAL04-202 · 2026-526087-20-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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