EUCTR2015-005064-42-GB进行中（未招募）1 期
A 12-Week Study to Assess the Efficacy and Safety of AF-219 in Subjects with Treatment Refractory Chronic Cough
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 253
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
- •Subjects who meet all of the following criteria will be included in the study:
- •1. Women and Men between 18 and 80 years of age inclusive
- •2. Have a diagnosis of refractory chronic cough or unexplained cough for at least one year (see ACCP/BTS guidelines in Appendix 1)
- •3. Have a score of = 40mm on the Cough Severity VAS at Screening
- •4. 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.
- •5. 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.
- •6. Have provided written informed consent.
- •7. 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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Subjects are NOT eligible for this study if they meet any of the following criteria:
- •1. Current smoker
- •2. Individuals who have given up smoking within the past 6 months
- •3. Initiation of treatment with an ACE-inhibitor within 4 weeks prior to the Baseline Visit (Day 0) or during the study
- •4. FEV1/FVC < 60%
- •5. History of upper or lower respiratory tract infection or recent significant change in pulmonary status within 4 weeks of the Baseline Visit (Day 0)
- •6. History of cystic fibrosis or bronchiectasis
- •7. History of opioid use within 1 week of the Baseline Visit (Day 0)
- •8. Requiring concomitant therapy with prohibited medications (see Section 6.6)
- •9. Body mass index (BMI) <18 kg/m2 or = 40 kg/m2
- •10. History or symptoms of renal disease or renal obstructive disease
- •11. History of triple phosphate kidney/bladder stones (nephro/uro-lithiasis)
- •12. History of conditions or disorders that predispose to nephrolithiasis such as inflammatory bowel disease (i.e., crohn’s disease and active ulcerative colitis) or short bowel syndrome
- •13. 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
- •14. History of concurrent malignancy or recurrence of malignancy within 2 years prior to Screening (not including subjects with <3 excised basal cell carcinomas)
- •15. History of a diagnosis of drug or alcohol dependency or abuse within approximately the last 3 years
- •16. Any condition possibly affecting drug absorption (e.g., gastrectomy, gastroplasty, any type of bariatric surgery, or vagotomy)
- •17. Screening systolic blood pressure (SBP) >160 mm Hg or a diastolic blood pressure (DBP) >90 mm Hg
- •18. Clinically significant abnormal electrocardiogram (ECG) at Screening, including any of the following:
- •a. QTc interval >450 milliseconds in males and >470 milliseconds in females
- •b. Atrial fibrillation or atrial flutter
- •c. Heart rate <40 beats per minute >110 bpm
- •19. Personal or family history of congenital long QT syndrome or family history of sudden death
- •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
- •21. History of cutaneous adverse drug reaction to sulfonamides or signs and symptoms suggestive of anaphylaxis to sulfonamides
- •22. Pregnant or Breastfeeding
- •23. Treatment with an investigational drug (except AF-219) or investigational biologic within 60 days preceding the first dose of study medication or plans to take another investigational drug or biologic within 30 days of study completion
- •24. Blood donation within 56 days or plasma donation within 7 days prior to dosing
- •25. Other severe, acute, o
研究者
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