CTRI/2019/10/021608尚未招募不适用
A Randomized, Double-Blind, Double-Dummy, Placebo Controlled, Single-Dose, Four-Period, Crossover, Multi-Center Bioequivalence Study to Compare the Bronchodilating Effect of Albuterol Sulfate Inhalation Aerosol (90 mcg/actuation as Albuterol) of Deva Holding A.S. with Proair® HFA Albuterol Sulfate Inhalation Aerosol (90 mcg/actuation as Albuterol) in Adult Asthmatics
Deva Holding AS6 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年10月21日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 6
- 主要终点
- Baseline adjusted average area-under-the-effect curve calculated from the zero time to six hours(AUEC0-6h)
研究概览
简要总结
A Bioequivalence Study, to compare the bronchodilating effect of Albuterol Sulfate Inhalation Aerosol (90 mcg/actuation as Albuterol) of Deva Holding A.S. with Proair® HFA Albuterol Sulfate Inhalation Aerosol (90 mcg/actuation as Albuterol) in Adult Asthmatics & to evaluate the safety and tolerability of investigational products.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or non-pregnant, non-lactating female subjects (18-65 years of age).
- •Moderate-to-severe asthma subjects based on NAEPP guidelines.
- •FEV1 within 40-70% of the predicted at screening visit.
- •Reversible airway obstruction demonstrated by an improvement of 15% or more in FEV1 30 minutes after inhalation of two puffs (0.18 mg) of Proair® HFA Albuterol Sulfate Inhalation Aerosol (90 mcg/actuation as Albuterol).
- •Nonsmoker for at least six months prior to the study and a maximum smoking history of five pack-years (the equivalent of one pack per day for five years) before that.
- •Willing to provide written informed consent to participate in this study.
- •History of asthma since at least last one year.
- •History of stable asthma a month prior to screening.
- •Subject must be able to demonstrate correct use of the metereddose inhaler (MDI) using the Vitalograph Aerosol Inhalation Monitor.
- •Able to comply with all study requirements and procedures.
排除标准
- •Known intolerance or hypersensitivity to any components of the albuterol MDI.
- •Intolerance to aerosolized β2-adrenergic agonists.
- •Prior treatment with systemic corticosteroids during the last 3months or subjects who are currently taking oral corticosteroids.
- •Use of long-acting β2-agonists in last 2 weeks prior to randomization.
- •Require continuous treatment with monoamine oxidase inhibitors, tricyclic antidepressants or β-blockers (administered by any route).
- •Dosage of any required inhaled corticosteroids, cromolyn and/or nedocromil are not stable for at least four weeks prior to the screening.
- •Subjects requiring subsequent dosage adjustment of these drug products during the study will be discontinued from the study.
- •Evidence of upper or lower respiratory tract infection (e.g., pneumonia, bronchitis, sinusitis) within six weeks prior to the study.
- •History of life-threatening asthma in the last three years, or ED (Emergency Department) visit or hospitalization for asthma in the last 12 months.
- •History of frequent exacerbations in the previous year.
- •Subjects whose asthma suspected to have been exclusively seasonal.
- •Other co-morbid respiratory and sinus diseases like tuberculosis, bronchitis, emphysema, COPD.
- •Inability to tolerate or unwillingness to comply with required washout periods or temporary withdrawal for all applicable medications and xanthine containing foods and beverages prior to screening and each study period.
- •Known or suspected substance abuse (e.g. Alcohol, marijuana, etc.) and /or any other criteria according to the investigator which may affect subject’s safety or study results
- •Inability to tolerate temporary withdrawal of current asthma medication.
- •History of status asthmaticus, cystic fibrosis or bronchiectasis.
- •Abnormal prolongation of QT-interval and/or ECG abnormalities ofclinical relevance.
- •Subjects with abnormal serum potassium value, which is clinically significant as per the opinion of investigator.
- •History of clinically significant cardiovascular, renal, neurologic, liver or endocrine dysfunction which in the opinion of the investigator, may put the subject at risk because of participation in the study, or influence the results of the study, or cause concern regarding the subject ability to participate in the study.
- •Pregnancy, breast-feeding, planned pregnancy during the study, or women of child-bearing potential not using adequate contraception.
- •Subjects with known positivity for human immunodeficiency virus (HIV), HBsAg and/or HCV.
- •Subject having night shift work for 1 week prior to screening.
- •Participation in any investigational drug study within 30 days prior to screening.
- •Institutionalized subjects.
- •Any other criteria according to the investigator which may compromise subject’s safety or study results.
结局指标
主要结局
Baseline adjusted average area-under-the-effect curve calculated from the zero time to six hours(AUEC0-6h)
时间窗: 7 Weeks
次要结局
- Baseline adjusted average area-under-the-effect curve calculated from the zero time to four hours (AUEC0-4h).(Baseline adjusted maximum FEV1 (FEV1max))
研究者
研究点 (6)
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