NCT07671911招募中3 期
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Nalbuphine Extended-Release Tablets for the Treatment of Chronic Cough in Participants With Idiopathic Pulmonary Fibrosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 306
- 试验地点
- 19
- 主要终点
- Relative Change from Baseline in 24-hour Cough Frequency at Week 26
研究概览
简要总结
The primary purpose is to evaluate the safety and efficacy of NAL ER for the treatment of chronic cough in participants with Idiopathic Pulmonary Fibrosis (IPF).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of IPF as determined by the Investigator based on American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Society (ALAT) clinical practice guidelines.
- •Chronic cough for ≥8 weeks prior to Screening.
- •PGI-Severity Score ≥ 2 at Screening.
- •Forced vital capacity (FVC) ≥40 percent (%) of predicted at Screening.
- •Diffusing capacity for carbon monoxide (DLCO) ≥25% of predicted during Screening or within 12 weeks prior to Screening.
- •Participants who are currently taking antifibrotic medication (nintedanib, pirfenidone, nerandomilast) approved for IPF should be on a stable dose for at least 6 weeks prior to the Baseline Visit.
排除标准
- •Clinical diagnosis or clinical suspicion of an upper or lower respiratory tract infection in the last 8 weeks prior to the Screening visit or during Screening.
- •Hospitalization for any respiratory illness (including acute exacerbation of IPF) within 2 months prior to Screening.
- •Note: Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
NAL ER 54 mg
Experimental
Participants will undergo a 2-week blinded titration period (twice daily [BID] dosing with one NAL ER once daily [QD] dose and one placebo QD dose) followed by a fixed dose treatment period receiving NAL ER 54 milligrams (mg) BID for 52 weeks.
干预措施: Placebo (Drug)
Placebo
Placebo Comparator
Participants will undergo a 2-week blinded titration period followed by a fixed dose treatment period receiving a matching placebo BID for 52 weeks.
干预措施: Placebo (Drug)
NAL ER 54 mg
Experimental
Participants will undergo a 2-week blinded titration period (twice daily [BID] dosing with one NAL ER once daily [QD] dose and one placebo QD dose) followed by a fixed dose treatment period receiving NAL ER 54 milligrams (mg) BID for 52 weeks.
干预措施: NAL ER (Drug)
结局指标
主要结局
Relative Change from Baseline in 24-hour Cough Frequency at Week 26
时间窗: Baseline, Week 26
次要结局
- Percentage of Participants Achieving ≥30%, ≥50% and ≥75% Reduction from Baseline in 24-Hour Cough Frequency(Baseline up to Week 54)
- Absolute Change from Baseline in the Cough Severity Numerical Rating Scale (CS-NRS) at Week 26(Baseline, Week 26)
- Relative Change from Baseline in 24-hour Cough Frequency at Week 6(Baseline, Week 6)
- Percentage of Participants Achieving ≥50% Reduction from Baseline in 24-hour Cough Frequency at Week 26(Baseline, Week 26)
- Absolute Change from Baseline in the Evaluating Respiratory Symptoms in Idiopathic Pulmonary Fibrosis (E:RS-IPF) Cough Domain at Week 26(Baseline, Week 26)
- Percentage of Participants Achieving a ≥3-point Improvement from Baseline in CS-NRS at Week 26(Baseline, Week 26)
- Absolute Change from Baseline in the E-RS:IPF Cough Domain(Baseline up to Week 54)
- Absolute Change from Baseline in the E:RS IPF Breathlessness Domain at Week 26(Baseline, Week 26)
- Relative Change from Baseline in 24-hour Cough Frequency(Baseline up to Week 54)
- Relative Change from Baseline in Awake Cough Frequency(Baseline up to Week 54)
- Absolute Change from Baseline in the E-RS:IPF Total Score and Domain Scores (IPF-Breathlessness, IPF-Cough, IPF-Sputum, and IPF-Chest Symptoms)(Baseline up to Week 54)
- Absolute Change from Baseline in the CS-NRS(Baseline up to Week 54)
- Percentage of Participants Achieving a ≥3-Point Improvement from Baseline in CS-NRS(Baseline up to Week 54)
- Absolute Change from Baseline in the Leicester Cough Questionnaire (LCQ) Total Scores(Baseline up to Week 54)
- Percentage of Participants Achieving a 1.3-Point Increase (Improvement) from Baseline in LCQ Total Score(Baseline up to Week 54)
- Absolute Change from Baseline in Each LCQ Domain Score (Physical, Psychological, Social)(Baseline up to Week 54)
- Change from Baseline in the European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) at Week 26(Baseline, Week 26)
- Relative Change from Baseline in Sleep Cough Frequency(Baseline up to Week 54)
- Absolute Change from Baseline in the Patient Global Impression of Severity (PGI-S) Cough Score(Baseline up to Week 54)
- Absolute Change from Baseline in the Patient Global Impression of Change (PGI-C) Cough Score(Baseline up to Week 54)
- Percentage of Participants with Improvements by ≥1 and ≥2 Categories from Baseline on the PGI-S Cough(Baseline up to Week 54)
- Safety and Tolerability as Assessed by Number of Participants with Treatment Emergent Adverse Events (TEAEs)(Up to Week 57)
- Absolute Change from Baseline in 24-hour Cough Frequency(Baseline up to Week 54)
研究者
研究点 (19)
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