EUCTR2015-000474-35-GB进行中（未招募）1 期
A Dose Escalation Study to Assess the Efficacy and Tolerance of AF-219 in Subjects with Refractory Chronic Cough
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 59
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
入选标准
- •1. Women and Men between 18 and 80 years of age inclusive
- •2. Chest radiograph or CT thorax within the last 12 months not demonstrating any abnormality considered to be significantly contributing to the chronic cough in the opinion of the Principal Investigator and Afferent Medical Monitor
- •3. Have refractory chronic cough for at least one year: a cough that is unresponsive to at least 8 weeks of targeted treatment for identified underlying triggers including reflux disease, asthma and post-nasal drip or unexplained cough: a cough for which no objective evidence of an underlying trigger can be determined after investigation
- •4. Have a score of = 40mm on the Cough Severity VAS at Screening
- •5. Women of child-bearing potential must use 2 forms of acceptable birth control method from Screening through the Follow-Up Visit. Acceptable birth control methods include established use of oral, injected, or implanted hormonal methods of contraception; intrauterine device (IUD) or intrauterine system
- •(IUS); tubal ligation; or male sterilization. Double-barrier method (diaphragm for female subject and condom for male partner with spermicidal) satisfies the requirement for 2 forms of acceptable birth control. When in line with the preferred life style of the subject, true and complete abstinence (not periodic abstinence) is acceptable.
- •6. Male subjects and their partners of child-bearing potential must use 2 methods of acceptable birth control, 1 of which must be a barrier method, and make no donation of sperm from Screening until 3 months after the last dose of study drug.
- •7. Have provided written informed consent.
- •8. Are willing and able to comply with all aspects of the protocol.
- •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 10
排除标准
- •1. Current smoker
- •2. Individuals who have given up smoking within the past 6 months, or those with >20 pack-year smoking history
- •3. Treatment with an ACE-inhibitor as the potential cause of a subject’s cough, or requiring treatment with an ACE-inhibitor during the study or within 4 weeks prior to the Baseline Visit (Day 0)
- •4. FEV1/FVC < 60%
- •5. History of upper respiratory tract infection or recent significant change in pulmonary status within 4 weeks of the Baseline Visit (Day 0)
- •6. History of opioid use within 1 week of the Baseline Visit (Day 0)
- •7. Requiring concomitant therapy with prohibited medications (see Section 6.6)
- •8. Body mass index (BMI) <18 kg/m2 or = 37 kg/m2
- •9. History or symptoms of renal disease or renal obstructive disease
- •10. History of kidney/bladder stones (nephro/uro-lithiasis) within 5 years of Screening
- •11. History of conditions or disorders that predispose to nephrolithiasis such Type 1 renal tubular acidosis, cystinuria, gout, hyperparathyroidism, inflammatory bowel disease (i.e., ulcerative colitis and crohn’s disease), short bowel syndrome, or bariatric surgery
- •12. Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 (using the Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) formula [http://mdrd.com/]) at Screening
- •13. History of concurrent malignancy or recurrence of malignancy within 2 years prior to Screening (not including subjects with <3 excised basal cell carcinomas)
- •14. History of a diagnosis of drug or alcohol dependency or abuse within approximately the last 3 years
- •15. Any condition possibly affecting drug absorption (e.g., gastrectomy, gastroplasty, any type of bariatric surgery, vagotomy, or bowel resection)
- •16. Screening systolic blood pressure (SBP) >160 mm Hg or a diastolic blood pressure (DBP) >90 mm Hg
- •17. Clinically significant abnormal electrocardiogram (ECG) at Screening, including any of the following:
- •a. QT (QTc) interval >460 milliseconds
- •b. Atrial fibrillation or atrial flutter
- •c. Heart rate <40 beats per minute >110 bpm
- •d. Second degree or third degree (complete) AV block
- •e. Left bundle branch block (including hemiblock)
- •f. Wolf-Parkinson-White Syndrome
- •18. Personal or family history of congenital long QT syndrome or family history of sudden death
- •19. Cardiac pacemaker
- •20. Significantly abnormal laboratory tests at Screening, including:
- •a. alkaline phosphatase (AP), alanine aminotransferase (ALT, SGPT), aspartate aminotransferase (AST, SGOT), or bilirubin >150% of the upper limit of normal (ULN)
- •b. hemoglobin < 10 gm/dL, WBC count <2500 mm3, neutrophil count <1500 mm3, platelet count <100 × 103/mm3
- •c. Positive tests for drugs of abuse
- •d. Positive tests at Screening for viral hepatitis defined by positive
- •immunoglobulin M (IgM) anti-hepatitis A virus (HAV), hepatitis B
- •virus (HepB) sAg, or anti-hepatitis C virus (HCV)
- •21. History of cutaneous adverse drug reaction to sulfonamides or signs and symptoms suggestive
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