CTRI/2024/11/076181尚未招募不适用
A Prospective, Randomized, Single-dose, Double-blind, Double-dummy, Four-period, Four-treatment Crossover Pivotal Bronchoprovocation Study to Demonstrate the Pharmacodynamic Bioequivalence of Albuterol sulfate HFA Inhalation Aerosol (E.Q. 90 mcg of albuterol Base/Inh) (of Macleods Pharmaceuticals Ltd.) to Albuterol sulfate HFA Inhalation Aerosol (E.Q. 90 mcg of albuterol Base/Inh) (distributed by Teva Pharmaceuticals USA, Inc.) in Adult Patients with Stable Mild Asthma.
Ms Macleods Pharmaceuticals Ltd21 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2024年11月5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
- 144
- 试验地点
- 21
- 主要终点
- To demonstrate pharmacodynamic (PD) bioequivalence (BE) of Albuterol sulfate HFA inhalation aerosol (E.Q. 90 mcg albuterol Base/Inh) (of Macleods Pharmaceuticals Ltd) (TÂ inhalation aerosol) to Albuterol sulfate HFA Inhalation Aerosol (E.Q. 90 mcg albuterol Base/Inh) (distributed by Teva Pharmaceuticals USA, Inc.) (R inhalation aerosol) as assessed by post-dose PC20.
研究概览
简要总结
This is a Prospective, Randomized, Single-dose, Double-blind, Double-dummy, Four-period, Four-treatment Crossover Pivotal Bronchoprovocation Study to Demonstrate the Pharmacodynamic Bioequivalence of Albuterol Inhalation Aerosol 90 mcg of Macleods Pharmaceuticals Ltd. to Albuterol Inhalation Aerosol 90 mcg Teva Pharmaceuticals USA, Inc. in Adult Patients with Stable Mild Asthma.
The Patients will be randomized to get 0 dose, 90 mcg of Reference, 90 mcg of Test or 180 mcg of Reference albuterol dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •(1.) Male and non-pregnant, non-lactating female subjects aged between 18 to 65 years (both ages inclusive).
- •(2.) Stable mild asthmatics based on National Asthma Education and Prevention Programme (NAEPP) guidelines.
- •(3.) Subjects who were diagnosed by physician with mild asthma at least 6 months prior to screening visit date.
- •(4.) Pre-bronchodilator forced expiratory volume in one second (FEV1) more than or equal to 80 percent of predicted.
- •(5.) Airway responsiveness to methacholine demonstrated by pre-albuterol-dose (baseline) PC20 less than or equal to 1.56 mg per mL using AeroEclipse II BAN and 1-minute tidal breathing method at Screening MCT A (6.) The more than or equal to 20 percent reduction in FEV1 at Screening MCT A relative to post-saline FEV1 should be obtained above the lowest methacholine concentration.
- •(7.) At Screening MCT-B, subjects should have at least four-fold increase in PC20 over Screening MCT-A (8.) At Screening MCT -B, the more than or equal to 20 percent reduction in FEV1 relative to post saline FEV1 must be obtained up to methacholine concentration 24.96 mg per mL (9.) Non-smokers for at least six months prior to screening visit and a maximum smoking history of five-pack years (the equivalent of one pack per day for five years).
- •(10.) Women of child-bearing potential or women who are less than or equal to 1 year postmenopausal prior to screening visit must have negative result for urine pregnancy test (11.) Women of child-bearing potential or women who are less than or equal to 1 year postmenopausal prior to screening visit must agree to the use of a reliable and medically acceptable method of contraception throughout the duration of the study (12.) Women of child-bearing potential or women who are less than or equal to 1 year postmenopausal prior to screening visit using hormonal contraception must be on the same hormonal contraceptive for at least thirty days before the screening period and must be continued same throughout the study.
- •(13.) Able to provide signed written informed consent and willing to comply with all aspects of the clinical study protocol.
排除标准
- •1.Subjects with FEV1 less than 1.5L during methacholine challenge test 2.Evidence of upper or lower respiratory tract infection (e.g., pneumonia, bronchitis, sinusitis) within six weeks prior to the study.
- •3.History of seasonal asthma exacerbations, in which case the subject should be studied outside of the relevant allergen season 4.History of cystic fibrosis, bronchiectasis or other respiratory diseases other than asthma (e.g., COPD, interstitial lung disease) 5.Treatment in an emergency room or hospitalization for acute asthmatic symptoms within past three months prior to screening visit 6.Need for daily oral corticosteroids within past three months prior to screening visit 7.History of life-threatening asthma leading to hospitalization within the past 1 year prior to screening visit 8.Known intolerance or hypersensitivity to any component of the albuterol metered dose inhaler (MDI) 9.Uncontrolled hypertension (systolic BP more than 200 mmHg, or diastolic BP more than 100 mmHg) 10.History or evidence of myocardial infarction or stroke 11.History of known aortic aneurysm 12.Current use of cholinesterase inhibitor medication (for myasthenia gravis) 13.Clinically significant ECG recording at screening such as flattening of T wave, prolongation of QTc interval ( more than 450 milliseconds), and ST segment depression, which in the opinion of the Investigator, would compromise subject’s safety or interfere with the study results 14.History of recent eye surgery or intracranial pressure elevation risk 15.Uncontrolled diabetes (HbA1c greater than or equal to 9%) at screening 16.Evidence or history of clinically significant disease or abnormality including congestive heart failure, uncontrolled artery disease, cardiac dysrhythmia, or ECG with evidence of ischemic heart disease.
- •In addition, historical or current evidence of significant hematologic, hepatic neurologic, psychiatric, renal, or other disease or that, in the opinion of the Investigator, would put the subject at risk through study participation, or would affect the study analyses if the disease exacerbates in the study 17.Presence of any abnormal clinically significant laboratory investigation at screening visit 18.History of paradoxical bronchospasm 19.Has participated in another investigational study or device research study within 30Â days before screening visit date 20.Women are pregnant, breast-feeding, or planning pregnancy during study.
结局指标
主要结局
To demonstrate pharmacodynamic (PD) bioequivalence (BE) of Albuterol sulfate HFA inhalation aerosol (E.Q. 90 mcg albuterol Base/Inh) (of Macleods Pharmaceuticals Ltd) (TÂ inhalation aerosol) to Albuterol sulfate HFA Inhalation Aerosol (E.Q. 90 mcg albuterol Base/Inh) (distributed by Teva Pharmaceuticals USA, Inc.) (R inhalation aerosol) as assessed by post-dose PC20.
时间窗: Period 1 to 4
次要结局
- To assess the safety profile of the test product compared to that of the reference product. Safety parameters, such as AEs physical examination, vital signs (BP, PR, and body temperature) and laboratory investigations.(Screening Visit to End of study)
研究者
Dr Ashish Mungantiwar
Macleods Pharmaceuticals Ltd
研究点 (21)
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