NCT01804218Unknown2 期
Efficacy and Safety of Beta-adrenoceptor Inverse Agonist, Nadolol, in Mild Asthma
Invion, Inc.3 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2013年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- The change in methacholine provocative concentration causing a 20% fall (PC20) based on forced expiratory volume in 1 second (FEV1) between baseline visit and final dose dispensing visit.
研究概览
简要总结
The purpose of this study is to test the hypothesis that 18-22 week treatment with the inverse agonist nadolol will improve airway hyperresponsiveness in patients with mild asthma, compared to placebo.
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
- •Individuals who meet all of the following criteria are eligible for enrollment as study participants:
- •Males and females with physician-diagnosed asthma between the ages of 18-
- •Pre-bronchodilator FEV1 80% or greater than the predicted value
- •Baseline PC20 (based on FEV1) ≤ 4 mg/ml on methacholine challenge test.
- •Asthma Control Questionnaire Score (ACQ) <1.25
- •Baseline blood pressure ≥ 110/65mm Hg
- •Baseline pulse rate ≥ 60 beats/min.
- •Never-smoker or former-smoker < 10 pack.year and has not smoked within 1 year.
- •Able to complete diary cards and comply with study procedures.
- •Females of childbearing age may participate only if they have a negative pregnancy test, are non-lactating, and agree to practice an adequate birth control method (abstinence, combination barrier and spermicide, or hormonal) for the duration of the study.
排除标准
- •Subjects who meet ANY of the following criteria are not eligible for enrollment:
- •Inability or unwillingness of the participant to give written informed consent
- •History of upper/lower respiratory tract infection or asthma exacerbation requiring systemic steroids within 6 weeks of Visit 1
- •Use of rescue medication (e.g., albuterol) more than twice per week during the week preceding Visit 1 excluding the use of such medication as preventative prior to exercise.
- •History of hospitalization for asthma in the preceding year
- •History of intubation for asthma
- •Currently diagnosed with chronic obstructive pulmonary disease (COPD)
- •Currently taking any beta-blocker medication
- •History of adverse reaction or allergy to any beta-blocker medication
- •History of neurological, hepatic, renal, or other medical conditions that may interfere with the interpretation of data or the patient's participation in the study or may increase safety concerns
- •Current diabetes or hyperthyroidism
- •History of cardiovascular diseases including uncontrolled hypertension (BP >160/100), ischemic heart disease, congestive heart failure, valvular heart disease or cardiomyopathy
- •Known allergy or sensitivity to atropine or ipratropium bromide
- •Abnormal entry laboratory values at baseline except for the following tests, where values outside the normal limits will be acceptable as follows: Hct ≥ 30%, platelet count > 100,000, ALT and AST < 1.5 x upper normal limit
- •Known bleeding disorders, platelet count <100,000, PT or PTT > 1.5 x normal control (if participating in bronchoscopy sub-study)
- •Known allergy to lidocaine (if participating in bronchoscopy sub-study)
- •Documented or self-reported current history of alcoholism or drug abuse
- •Participation in another research trial within 30 days of starting this trial
- •Unwillingness or inability to comply with study procedures
- •Inability to swallow the study medication capsule
- •Use of any exclusion medication within the time period specified
- •Pregnant or nursing
- •Receiving allergen immunotherapy (desensitization injections)
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
Active, nadolol
Experimental
Active
干预措施: Nadolol (Drug)
结局指标
主要结局
The change in methacholine provocative concentration causing a 20% fall (PC20) based on forced expiratory volume in 1 second (FEV1) between baseline visit and final dose dispensing visit.
时间窗: 4 months
次要结局
未报告次要终点
研究者
研究点 (3)
Loading locations...
相似试验
招募中
不适用
Clinical trial for the effect of beta2 adrenargic receptor polymorphism to long acting beta agonist induced hypokalemia.JPRN-UMIN000005756Department of pulmonary medicine, Kagoshima university Graduate school of medical and dental sciences40
已完成
2 期
Efficacy and Safety of Βeta-adrenoceptor Inverse Agonist and Biased Ligand, Nadolol, In Smoking Cessation of Patients With Chronic Cough With or Without Airflow ObstructionSmoking CessationNCT01825122Invion, Inc.155
已完成
2 期
Study Investigating Repeat Doses Of A New Medication (GSK159797) In Asthmatic PatientsPulmonary Disease, Chronic ObstructiveNCT00358488GlaxoSmithKline54
终止
不适用
Feasibility - Beta Adrenergic Blockade (BB) in Cervical Cancer (CX)Cervical CancerNCT01902966M.D. Anderson Cancer Center6
进行中（未招募）
2 期
Terazosin and Parkinson's Disease Extension StudySymptomatic Parkinson DiseaseREM Sleep Behavior DisorderPre-motor Parkinson's DiseaseNCT05109364Cedars-Sinai Medical Center15