EUCTR2013-003566-13-GB进行中（未招募）不适用
A Randomised, Double-Blind, Double-Dummy, Placebo-Controlled, Three-Way Cross-over Study to evaluate the effect of AF-219 on methacholine hyper-reactivity in subjects with asthma. - A study of the effects of AF-219 on airway hyper-reactivity in asthma.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
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
- •Subjects who meet all of the following criteria will be included in the study:
- •1. Age between 18 and 65 years, inclusive.
- •2. Women of child bearing potential (i.e., women who are not surgically sterile, not having had hysterectomy, bilateral tubal occlusion or bilateral oophorectomy, or are not post-menopausal) must have a negative pregnancy test at Screening and prior to randomisation. Definition of postmenopausal status is having been naturally (spontaneously) amenorrhoeic for more than 12 months with an appropriate clinical profile, eg, age appropriate, history of vasomotor symptoms. Women of child-bearing potential must be using 2 forms of acceptable birth control method from Screening through the Follow-Up Visit. Acceptable birth control methods include (of which 2 must be used):
- •established use of oral, injected or implanted hormonal methods of contraception;
- •intrauterine device (IUD) or intrauterine system (IUS);
- •Condom with spermicide
- •Diaphragm with spermicide
- •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.
- •3. Male subjects with partners of child-bearing potential (as defined in Inclusion No. 2) must use 2 methods of acceptable birth control with their partner, 1 of which must be a barrier method. Contraception must start from screening and continue until 3 months after last dose of study drug
- •4. Non-smokers or former smokers, who stopped smoking 6 months prior to screening. Former smokers should not have a smoking history of more than 5pack years (1 pack of 20 cigarettes per day over 5 years).
- •5. Pre-bronchodilator (after abstaining from Short acting ß2-agonist for =8 hrs) Forced Expiratory Volume (FEV1) =70% of the predicted normal value at the initial screening visit for the purposes of eligibility.
- •6. Pre-bronchodilator (after abstaining from Short acting ß2-agonist for =8 hrs) Forced Expiratory Volume (FEV1) =70% of the predicted normal value OR if less than 70% must be within +/- 12 % of screening FEV1 prior to randomization. NB: This visit must not be rescheduled if criteria are not met.
- •7. Physician documented history or diagnosis of asthma for at least 6 months prior to screening according to the Global Initiative in Asthma guidelines (GINA, 2012).
- •8. Requires the use of Short acting ß2-agonist therapy only (= 8 puffs per day) for at least 4 weeks prior to screening and prior to randomisation.
- •9. Positive response to methacholine challenge (PC20 = 8 mg/mL) at screening.
- •10. Positive response to ATP challenge (PC20 = 200 µmol/mL) at screening.
- •11. Have provided written informed consent
- •12. 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: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 19
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •Subjects are NOT eligible for this study if they meet any of the following criteria:
- •1. Has been hospitalised or attended the emergency department for an asthma attack in the 12 months prior to screening.
- •2. Exacerbation of asthma or Lower respiratory tract infection during the 4 weeks before screening or prior to randomisation
- •3. Upper respiratory tract infection during the 4 weeks before screening or prior to randomization requiring treatment with antibiotics.
- •4. Inhaled or systemic corticosteroids (oral, intravenous, intramuscular) within 4 weeks prior to screening or prior to randomisation.
- •5. Short-acting or long-acting antihistamines within 48hrs or 7 days, respectively, prior to screening.
- •6. Body mass index (BMI) <18 kg/m2 or = 35 kg/m2 at screening
- •7. History of kidney/bladder stones (nephro/uro-lithiasis) within 5 years of Screening
- •8. History of conditions or disorders that predispose to nephrolithiasis, such as 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
- •9. History of concurrent malignancy or recurrence of malignancy within 2 years prior to Screening (not including subjects with basal cell carcinomas or cervical carcinoma in situ that has been successfully treated surgically)
- •10. Personal or family history of congenital long QT syndrome
- •11. Presence of a cardiac pacemaker
- •12. History of a diagnosis of drug or alcohol dependency or abuse within approximately the last 3 years
- •13. Diagnosis of depression, psychosis, bipolar disorder, or schizoaffective disorder
- •14. In the opinion of the Investigator, in discussion with the Medical Monitor if required, an uncontrolled or unstable, clinically significant neurological, psychiatric, respiratory, cardiovascular, peripheral vascular, gastrointestinal, hepatic, pancreatic, endocrinological, hematological, or immunological disorder or an active infection
- •15. Patients with diabetes Type I or uncontrolled diabetes Type II or HbA1c > 8.0% at screening.
- •16. Any condition possibly affecting drug absorption e.g., gastrectomy, gastroplasty, any type of bariatric surgery, vagotomy, or bowel resection
- •17. Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 (using the(CKD EPI) formula (Levey, 2009) at screening
- •18. Systolic blood pressure >160 mm Hg or a diastolic blood pressure >90 mm Hg or Heart rate <40 bpm or >110 bpm at screening or prior to randomisation.
- •19. Clinically significant abnormal electrocardiogram (ECG) at Screening, including any of the following:
- •a. QTcB interval >450 milliseconds in males, >470 milliseconds in females
- •b. Atrial fibrillation or atrial flutter
- •c. Heart rate <40 bpm or >110 bpm
- •d. Second degree or third degree (complete) AV block
- •e. Left bundle branch block (including hemiblock)Wolf-Parkinson-White Syndrome
- •20. Significantly abnormal laboratory tests at Screening, including:
- •a) alkaline phosphatase (AP), alanine aminotransferase (SGPT, ALT), aspartate aminotransferase (AST, SGOT), or bilirubin >150% of the upper limit of normal (ULN)
- •b) hemoglobin < 11 gm/dL in males / < 10 gm/dL in females, white blood cell (WBC) count <2.5x109 /L, neutrophil count <1.5 x10^9 /L, platelet count <100 × 10^9/L
- •c) Positive tests for drugs of abuse at screening or prior to randomisation
- •d) Positive alcohol breath test at screening or prior to randomisation
- •e) Positive tests for human immunodeficiency virus (HIV) or
研究者
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