EUCTR2010-024283-18-GBActive, not recruitingNot Applicable
A Study to Assess the Efficacy of AF-219, a P2X3 Receptor Antagonist, in Subjects with Chronic Cough - EPICC
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 25
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Subjects are eligible for inclusion if they meet the following inclusion criteria:
- •1. Men and women =18 and =80 years of age
- •2. Written informed consent from the subject
- •3. History of cough for more than 8 weeks
- •4. Normal chest radiograph
- •5. Idiopathic or treatment resistant cough (idiopathic defined as a cough for which no objective evidence of an underlying trigger can be determined after investigation) or a cough that is unresponsive to 8 weeks of targeted treatment for identified underlying triggers including reflux disease, asthma and post-nasal drip (treatment-resistant).*
- •6. Women must be post-menopausal, with no menses for 12 months without an alternative medical cause, or if of child-bearing potential must have a negative pregnancy test and agree to use one of the following acceptable birth control methods from screening visit to follow-up contact:
- •True complete abstinence when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence such as calendar, ovulation, symptothermal or post-ovulation methods are not acceptable methods of contraception),
- •Surgical sterilization of either the female subject in study (e.g., bilateral tubal ligation) or of her male partner (vasectomy with documented azoospermia) if he is the sole partner of that subject,
- •Established hormonal contraception (implantable, patch, oral or intramuscular [IM]) administered for at least one month prior to study medication administration
- •An intrauterine device (IUD) or intrauterine system (IUS) with failure rate of less than 1% per year inserted by qualified physician at least one month prior to study medication administration,
- •Double barrier method: condom and occlusive cap (diaphragm) with spermicidal foam/gel/film/cream/suppository,
- •* Investigations will include bronchial provocation testing (to exclude asthma), ear, nose, and throat (ENT) examination (to exclude post-nasal drip syndrome) and either 24 hour impedance/pH testing or an 8 week trial of twice daily proton pump inhibitor/H2 receptor blocker (to exclude reflux disease). All these tests are performed routinely according to North West Lung Centre management protocol in the clinic and only subjects who have already been investigated will be invited to participate in the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 18
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 7
Exclusion Criteria
- •Subjects must NOT meet any of the following exclusion criteria:
- •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 Day 0.
- •4. FEV1/FVC <60%
- •5. History of upper respiratory tract infection within 4 weeks of the Baseline Visit
- •6. History of opioid use within 1 week of the Baseline Visit
- •7. History of pregabalin use within 4 weeks of the Baseline Visit
- •8. Body mass index (BMI) <18 or >35
- •9. History of urinary tract infection within 6 months prior to Screening
- •10. History or symptoms of renal disease, including nephro/urolithiasis, pyelonephritis, or renal obstructive disease
- •11. History of conditions or disorders which predispose to nephrolithiasis such as frequent and recurrent urinary tract infections, Type 1 renal tubular acidosis, cystinuria, gout, hyperparathyroidism, inflammatory bowel disease, short bowel syndrome, bariatric surgery
- •12. History of stroke or transient ischemic attack within 2 years prior to Screening or residual deficits that would preclude completion of study activities
- •13. History of life-threatening neoplasms within 5 years prior to study entry, other than carcinoma in situ of the cervix or squamous or basal cell carcinoma of the skin
- •14. History of drug or alcohol dependency or abuse within approximately the last 5 years
- •15. Clinically significant depression or a history of suicide behavior or suicidal ideation unless the Investigator and Medical Monitor conclude, based upon an assessment by a qualified mental health professional, that the subject may safely participate in the study
- •16. In the opinion of the Investigator and Medical Monitor, an uncontrolled or unstable, clinically significant neurological, psychiatric, respiratory, cardiovascular, peripheral vascular, gastrointestinal, hepatic, pancreatic, endocrinological, hematological, or immunological disorder or an active infection
- •17. Any condition possibly affecting drug absorption (e.g., gastrectomy, vagotomy or bowel resection)
- •18. Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 (using the Modification of Diet in Renal Disease [MDRD] formula [http://mdrd.com/])
- •19. Screening systolic blood pressure greater than 160 mm Hg or a diastolic blood pressure greater than 90 mm Hg
- •20. Clinically significant abnormal electrocardiogram (ECG) at Screening, including
- •a. Prolongation of QT/QTc (corrected QT) interval (>450 milliseconds in males, >460 milliseconds in females)
- •b. atrial fibrillation, atrial flutter,
- •c. notable bradycardia (heart rate <45 bpm) or tachycardia (HR >100 bpm)
- •d. complete (left or right) branch block,
- •e. Wolf-Parkinson-White Syndrome,
- •f. cardiac pacemaker
- •21. Significantly abnormal laboratory tests, including:
- •a. Screening alkaline phosphatase (AP), alanine aminotransferase (SGPT, ALT), aspartate aminotransferase (SGOT, AST), or bilirubin greater than 150% of the upper limit of normal (ULN)
- •b. Screening haemoglobin <10 g/dL,white blood cell (WBC) <2500 mm3, neutrophil count <1500 mm3, platelet count <100 × 103/mm3
- •c. Screening haemoglobin A1C =7.0
- •d. Screening microscopic haematuria, defined as =5 red blood count (RBC) per high-power field (hpf) on microscopic urinalysis
- •22. Post-void residual >200 mL at Screening
- •23. Clinically significant abnorma
Investigators
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