EUCTR2018-004744-31-GB进行中（未招募）1 期
A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Two-Treatment, Two-Period Crossover Efficacy and Safety Study in Idiopathic Pulmonary Fibrosis With Nalbuphine ER Tablets for the Treatment of Cough - CANA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Diagnosis of definite” or probable” IPF based on ATS/ERS/JRS/ALAT criteria.
- •2. Forced vital capacity (FVC) > 40% predicted of normal.
- •3. Diffusing capacity of the lung for carbon monoxide corrected for hemoglobin [DLco] > 25% predicted of normal within the past 6 months. Subjects who have not had DLco testing may be enrolled with medical monitor approval.
- •4. Chronic cough > 8 weeks.
- •5. Adequate swallow reflex as assessed by the ability to sip 3 fluid oz (or 89 ml) of water without coughing or choking.
- •6. Daytime cough severity score = 4 on Cough Severity Numerical Rating Scale at screening.
- •7. Males or females age 18 years and older at the time of consent.
- •8. Females of childbearing potential must use an acceptable method of birth control (if sexually active). All females of childbearing potential must have a negative pregnancy test at the screening and baseline visits.
- •9. Willing and able to understand and provide written informed consent.
- •10. Willing and able to comply with study requirements and restrictions.
- •11. Agree to the confidential use and storage of all data and use of all anonymized data for publication including scientific publication.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •1. The following conditions are excluded:
- •a) Interstitial lung disease (ILD) known to be caused by domestic and occupational environmental exposures.
- •b) Interstitial lung disease (ILD) known to be caused by connective tissue disease.
- •c) Interstitial lung disease (ILD) known to be caused by drug related toxicity.
- •2. Currently on continuous oxygen therapy for longer than 16 hours at any level or delivered by any modality. Intermittent oxygen use of any duration over any given 24-hr period is allowed.
- •3. Upper or lower respiratory tract infection within 4 weeks of screening.
- •4. Clinical diagnosis of sleep apnea and/or use of continuous positive airway pressure (CPAP).
- •5. Clinical diagnosis of aspiration pneumonitis.
- •6. Documented or clinically suspected hypercapnia (pCO2 >6.0kPa).
- •Medication-related Exclusions:
- •7. Potential subjects cannot have received opiates, including opiate containing anti-cough agents, within 14 days prior to the screening period. Subjects are prohibited from using opioids, including naltrexone, for the duration of the study.
- •8. Change of IPF-related drug treatment regimen within 8 weeks of screening.
- •9. Potential subjects cannot currently be receiving benzodiazepines or other CNS Depressant Class Drugs that when used concomitantly with opioids are known to have the potential to cause added pharmacologic effects of depressing CNS activity.
- •10. Potential subjects cannot currently be receiving medications that affect serotonergic neurotransmission and that when used concomitantly with opioids can cause serotonin syndrome.
- •11. Alcohol consumption should be limited for the duration of study treatment (due to the potential cause of added pharmacologic effects of CNS depression when used concomitantly with opioids.
研究者
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