A Prospective, Randomized, Single-Dose, Double-Blind, Double-Dummy, Four-Period, Four-Sequence, Four-Treatment, Placebo andActive Controlled, Comparative, Multicenter, CrossoverBronchoprovocation Pilot Study to Demonstrate the Pharmacodynamicequivalence of Albuterol Sulfate Inhalation Aerosol EQ 90 mcg Base/Inh(of Macleods Pharmaceuticals Ltd.) to ProairÂ® HFA (Albuterol Sulfate)Inhalation Aerosol EQ 90 mcg Base/Inh (Teva Respiratory, LLC) inAdult Patients with Stable Mild Asthma.

MACLEODS PHARMACEUTICALS LTD1 个研究点分布在 1 个国家目标入组 24 人开始时间: 2021年10月10日最近更新: 2021年11月10日

试验速览

阶段: 3 期
状态: 招募中
发起方: MACLEODS PHARMACEUTICALS LTD
入组人数: 24
试验地点: 1
主要终点: before the Placebo or Albuterol administration

研究概览入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Investigational Products/Study Treatments

Test Product (T): Albuterol sulfate inhalation aerosol (90 mcg Base/Inh) (of Macleods Pharmaceuticals Ltd.)

Reference Product (R): ProairÂ® HFA Albuterol sulfate inhalation aerosol (90 mcg Base/Inh) (Teva Respiratory, LLC)

Test Placebo (Tp): Placebo Inhaler similar to Test Product

Reference Placebo (Rp): Placebo Inhaler similar to ProairÂ® HFA

Study treatments: â€¢ Zero dose, â€¢90 mcg of R, â€¢180 mcg of R, â€¢90 mcg of T

Planned Study Sites - The trial is planned to be conducted at approximately 4 sites in India.

Study Population - 24 randomized males and non-pregnant females with stable mild asthma as per National Asthma Education and Prevention Program (NAEPP) guidelines will be included.

Study Design/Methodology - This is a prospective, randomized, single-dose, double-blind, double-dummy, four-period, four-sequence, four-treatment, placebo and active-controlled, comparative, multicenter, crossover bronchoprovocation pilot study to demonstrate the pharmacodynamic equivalence of Albuterol sulfate inhalation aerosol, EQ 90 mcg Base/Inh (Macleods Pharmaceuticals Ltd.) to ProairÂ® HFA (albuterol sulfate) inhalation aerosol, EQ 90 mcg Base/Inh (Teva Respiratory, LLC) in adult patients with stable mild asthma.

Safety objective - Safety and tolerability of the investigational product (IP)

Methacoline challenge, saline control, and spirometry - A methacoline challenge testing procedures as per ATS requirements will be followed in the study.

Primary Pharmacodynamic Endpoint - Post-dose PD20 which is a provocative dose (PD) of methacholine challenge agent required to reduce the forced expiratory volume in one second (FEV1) by 20% following administration of differing doses of Albuterol or Placebo inhalation

Secondary Pharmacodynamic Endpoint - Post-dose PC20 which is a provocative concentration (PC) of methacholine challenge agent required to reduce the FEV1 by 20% following administration of differing doses of Albuterol or Placebo inhalation

Safety Endpoints - Incidence of adverse events during the study period Clinically significant change in serum potassium, random blood sugar (RBS), vital signs and 12-lead electrocardiogram (ECG) recordings during the study period

研究设计

研究类型: Interventional

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 aged between 18 to 65 years (both inclusive)
•Stable mild asthmatics based on National Asthma Education and Prevention Program (NAEPP) guidelines
•Forced expiratory volume in one second (FEV1) more than or equal to 80% of predicted
•Airway responsiveness to methacholine demonstrated by pre-albuterol-dose (baseline) PC20 less than or equal to 8 mg/mL
•Non-smokers for at least six months prior to study and a maximum smoking history of five-pack years (the equivalent of one pack per day for five years)
•Able to demonstrate correct use of the pressurized metered dose inhaler using the training kit provided
•Must be able to perform acceptable and repeatable spirometry as per American Thoracic Society (ATS) guidelines
•Able to provide written informed consent and willing to comply with all aspects of the trial.

排除标准

•Known intolerance or hypersensitivity to active or inactive ingredient of the investigational products or saline or methacholine chloride
•Evidence of upper or lower respiratory tract infection, e.g. pneumonia, bronchitis, sinusitis, within six weeks prior to study
•History of seasonal asthma exacerbation in which case the subject should be studied outside of relevant allergen season
•History of cystic fibrosis, bronchiectasis or other respiratory diseases
•History of cardiovascular, renal, neurologic, liver or endocrine dysfunction, including ECG with evidence of ischemic heart disease
•Treatment in an emergency room or hospitalization for acute asthmatic symptoms or need for daily oral corticosteroids within past three months
•History of severe exacerbation in the last one year prior to screening and mild to moderate exacerbations in the last 6 weeks prior to screening
•Inability to tolerate or unwillingness to comply with required washout periods or unable to temporarily withdraw applicable asthma-medications and/or follow life-style restrictions (e.g. restriction of xanthine containing foods and beverages) prior to screening and each study period
•Abnormal prolongation of QT/QTc-interval (males: >430 ms and females: >450 ms) and/or any other clinically significant electrocardiogram (ECG) abnormalities which in the opinion of the investigator may affect subjectâ€™s safety during the study or interfere with the study results
•Serum potassium levels and random blood sugar levels outside the range (serum potassium range: 3.7 to 5.2 mEq/L; random blood sugar range: 80 to 140 mg/dL) and hemoglobin A1c (HbA1c) more than 8%
•Males or females planning pregnancy during the study duration
•Males or females of childbearing potential not willing to use adequate and consistent contraception methods during the study period
•Positive serology test results at screening for human immunodeficiency virus (HIV) I and HIV II, hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) at screening
•Subjects who have been treated in a clinical trial with an investigational drug or investigational device within a period of 90 days prior to screening
•Any clinically significant acute or chronic illness that could compromise the integrity of study data or affect the analyses if the disease exacerbates during the study or place the subject at risk by participating in the study
•Any elective, pre-planned or scheduled surgery or hospitalizations prior to start of the study
•Subjects with history of surgery within six weeks prior to screening, which in the opinion of the investigator interferes with study treatment results or affects the safety of the subject during the study
•Known history of drug/substance abuse.