NCT01439308已完成2 期
A Randomized, Double Blind, Placebo Controlled Study to Assessthe Effect of Intranasal Single Dose SB-705498 on the Response Tointranasal Capsaicin Challenge in Non-allergic Rhinitis Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Assessment of total symptom score (TSS) after unilateral, incremental dose, intranasal challenge with capsaicin
研究概览
简要总结
This study is designed to look at the affect of SB-705498 on rhinitis symptoms, as induced by capsaicin challenge
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NAR patients
- •Male or female between 18 and 60 years of age inclusive.
- •Non-child bearing women or women of child bearing potential if they agree to use contraception as indicated by the protocol
- •Non-smoker for at least 6 months with a pack history <5 pack years (Pack years = (No. of cigarettes smoked/day/20) x No. of years smoked).
- •Body weight > 50 kg and body mass index (BMI) within the range 19 - 29.9 kg/m2 (inclusive).
- •Capable of giving written informed consent.
- •Available to complete all the required study measurements.
- •Normal 12-lead ECG at screening.
- •Subject must demonstrate reactivity to unilateral, intranasal challenge with the selected single dose of capsaicin, defined as development of TSS ≥
- •Normal levels of total plasma IgG and negative allergy skin or Rast test to common aeorallergens.
- •Good general health, apart from NAR, as determined by a responsible physician.
排除标准
- •Past medical history of allergic rhinitis or rhinosinusitis.
- •Nasal conditions likely to affect the outcome of the study, i.e. nasal septal perforation, nasal polyps, other nasal malformations.
- •A history of gastrointestinal, hepatic, renal or multiple cardiovascular risk factors.
- •Positive pre-study drug/alcohol screen.
- •Positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
- •A positive test for human immunodeficiency virus (HIV) antibody (if determined by the local standard operating procedures (SOPs)).
- •History of regular alcohol consumption within 6 months of the study.
- •Exposure to more than four new chemical entities within 12 months prior to the start of the study.
- •Participation in a clinical trial with a new molecule entity or any other clinical trial within 4 months of the start of the study.
- •Use of prescription or non-prescription drugs, as well as of vitamins, herbal and dietary supplements (including St John's Wort) within 2 days prior to each study visit in Part 1 of the study or 14 days prior to the first treatment administration in Part 2 of the study.
- •Inability to abstain from all intranasal or oral medication to treat nasal symptoms from the first capsaicin challenge to the completion of the study including: sodium cromoglycate, antihistamines, anticholinergics, alpha-adrenergic agonists and corticosteroids
- •History of drug or other allergy that, in the opinion of the Investigator or GSK Medical Monitor, contraindicates their participation.
- •Subjects demonstrating hypersensitivity to the placebo capsaicin challenge at baseline screening.
- •Donation of blood or blood products in excess of 500mL within a 56 day period prior the start of Part 2 of this study.
- •Pregnant females as determined by positive serum or urine human chorionic gonadotropin (hCG) test at screening or prior to dosing.
- •Lactating females.
- •Unwillingness or inability to follow the procedures outlined in the protocol.
- •History of sensitivity to heparin or heparin-induced thrombocytopenia.
- •Nicotine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
- •For Part 2 only: Subjects with known lactose intolerance.
研究组 & 干预措施
Arm 2
Active Comparator
3 incremental capsaicin doses
干预措施: SB-705498 (Drug)
Arm 1
Placebo Comparator
3 incremental capsaicin doses
干预措施: Placebo (Drug)
结局指标
主要结局
Assessment of total symptom score (TSS) after unilateral, incremental dose, intranasal challenge with capsaicin
时间窗: 0-4hours following dosing
Assessment of total Ipsilateral secretion's weight after unilateral, incremental dose, intranasal challenge with capsaicin
时间窗: 0-4hours following dosing
次要结局
- Change from baseline in peak nasal inspiratory flow (PNIF) after unilateral, incremental dose, intranasal challenge with capsaicin(0-4hours following dosing)
- Intranasal, single dose SB-705498 plasma PK parameters-Cmax(0-4hours)
- Intranasal, single dose SB-705498 plasma PK parameters- Tmax(0-4hours post dosing)
- Assessment of Total Contralateral secretion's weight after unilateral, incremental dose, intranasal challenge with capsaicin(0-4hours following dosing)
- Number of participants with Individual Symptoms as assessed by TSS components after unilateral, incremental dose, intranasal challenge with capsaicin(0-4hours)
- Soluble biochemical mediators, including but not limited to neuropeptides, in nasal secretions induced after unilateral, incremental dose, intranasal challenge with capsaicin(0-4hours following dosing)
- Intranasal, single dose SB-705498 plasma PK parameters- AUC(0-t)(0-4hours post dosing)
- Number of participants with adverse events(Day 1)
- Number of participants with vital signs data outside range of potential clinical importance- Systolic blood pressure (SBP) and diastolic blood pressure (DBP)(Day 1)
- Heart rate(Day 1)
- Number of participants with nasal examination data(Day 1)
- Number of participants with abnormal ECG findings(Day 1)
- Body temperature(Day 1)
- Number of participants with abnormal hematology values(Day 1)
- Number of participants with abnormal clinical chemistry values- Carbon dioxide content/Bicarbonate, Cholesterol, Potassium, Triglycerides(Day 1)
- Number of participants with abnormal clinical chemistry values- Creatinine(Day 1)
- Number of participants with abnormal clinical chemistry values- Gamma Glutamyl Transferase, Lactate Dehydrogenase(Day 1)
研究者
研究点 (1)
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