CTRI/2024/03/064870已完成不适用
A Randomized, Single dose, Double blind, Double dummy, Placebo and Active Controlled, Crossover Design Study Using Bronchoprovocation to Evaluate the Pharmacodynamic Equivalence of the Test and Reference Metered Dose Inhalers (MDIs) Containing Albuterol Sulfate in Adult Patients with Stable Mild Asthma.
Intech Biopharm Limited8 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2024年4月30日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 8
- 主要终点
- To evaluate PD profile of the test product of albuterol sulfate inhalation aerosol 108 mcg per actuation (equivalent to 90 mcg of albuterol base) and to determine its bioequivalence to the PD profile of RLD in adult patients with stable mild asthma
研究概览
简要总结
This study is a single-dose, randomized, double blind, double dummy, four-sequence, four-treatment, and multi-centre study design to assess the PD bioequivalence between the test albuterol sulfate (T) inhalation aerosol 108 mcg per actuation (eq. to albuterol base 90 mcg/puff) and the reference albuterol sulfate (R) (ProAir HFA or FDA authorized generic: Albuterol Sulfate HFA [Teva Pharmaceutical USA, Inc.]) inhalation aerosol 108 mcg per actuation (equal to albuterol base 90 mcg/puff). The two products will be studied using a crossover design in patients with stable mild asthma by administering a minimum of 3 doses of reference product (0, 90, 180 mcg albuterol) and 2 doses of test product (0, 90 mcg albuterol). The bronchodilation potency of albuterol sulfate are measured by the inhibition effects of methacholine challenge on the bronchodilation, as indicated by increase in the provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20). Each subject will participate in for a minimum of 14 days and up to a maximum of 42 days, including a Screening Period and a telephone call 3 to 7 days after the final dose of study drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male, nonpregnant and nonlactating female subjects (20 to 65 years of age, inclusive).
- •A clinical diagnosis of mild asthma with historical documentation of the asthma diagnosis according to either (1) the National Asthma Education and Prevention Program (NAEPP) guidelines (2007) or (2) the Global Initiative for Asthma (GINA) Global Strategy for Asthma Management and Prevention (2020).
- •Stable mild asthma receiving the following required inhaled medications for at least 1 month prior to screening Low doses of ICS alone, or in combination with SABA, used regularly with a stable regimen.
- •Forced Expiratory Volume in 1 second (FEV1) greater than or equal to 80 percentage of the local predicted normal value after withholding SABA greater than or equal to 8 hours.
- •Airway responsiveness to methacholine demonstrated by a pre albuterol dose (baseline) PC20 smaller than or equal to 8 mg per mL.
- •Nonsmoker for at least 6 months prior to the study and a maximum smoking history of 5 pack years (the equivalent of one pack per day for 5 years).
- •Provision of written informed consent.
- •Other than asthma, in general good health.
- •Body mass index (BMI) between 17 and 35 kg per m2 (inclusive).
- •Able to correctly use MDI inhalers.
- •Able to perform valid and reproducible pulmonary function tests including no evidence of spirometry effort induced bronchoconstriction.
- •If the subject or subjects partner is of childbearing potential, a medically acceptable form of contraception will be used for the duration of the study.
- •Medically acceptable contraceptives including (1) surgical sterilization, (2) Health Authority approved female hormonal contraceptives, (3) an intrauterine device (IUD), (4) condoms with spermicide, or (5) diaphragm with spermicide.
排除标准
- •Evidence of conditions altering airway reactivity to methacholine, including upper or lower respiratory tract infections (e.g., pneumonia, viral bronchitis, allergic rhinitis, sinobronchitis, etc.) within 6 weeks before Screening.
- •Evidence of a baseline FEV1 less than 60 percentage of the local predicted normal value or FEV1 less than 1.5 L.
- •History of seasonal asthma exacerbations, in which case the subject should be studied outside of the relevant allergen season.
- •History of cystic fibrosis, bronchiectasis, COPD, or other respiratory diseases including COPD, chronic bronchitis, emphysema, tuberculosis, pulmonary carcinoma, pulmonary fibrosis, pulmonary hypertension that, in the opinion of the Investigator, would compromise subject safety or interfere with the evaluations.
- •History of cardiovascular, hematological, renal, neurologic, hepatic, psychiatric, endocrine dysfunction, including ECG with evidence of ischemic heart diseases and significant arrhythmias.
- •Treatment in an emergency room or hospitalization for acute asthmatic symptoms within 3 months prior to screening.
- •Known intolerance or hypersensitivity to any component of the albuterol MDI, beta2 receptor-agonist drug, HFA, any related compounds or methacholine.
- •Need for daily oral corticosteroids within 3 months prior to screening.
- •Cardiac arrhythmia or 12 lead electrocardiogram (ECG) abnormalities, that in the opinion of the Investigator would compromise subject safety or interfere with the evaluations, or a QTc more than 440 ms for males and more than 460 ms for females using Fredericia formula.
- •Subjects receiving beta blocker via any route or who may require beta blockers during the study.
- •History of narrow angle glaucoma, convulsive disorders, hyperthyroidism, uncontrolled diabetes, paradoxical bronchospasm.
- •History of malignancies.
- •History of alcohol or drug abuse.
- •Eye, brain, thoracic, and abdominal surgeries within 3 months prior to screening.
- •Use of cromyolyn, leukotriene receptor antagonists (LTRA), nedocromil, zileuton, theophylline, or long-acting beta-agonists (LABA) within 1 month prior to screening.
- •History of receiving muscarinic beta2-agonists (MABAs), short acting muscarinic antagonists (SAMAs), long-acting muscarinic antagonists (LAMAs), anti-IgE, anti-IL5/5R, anti-IL4R, high dose, or systemic corticosteroid for treatment of asthma within 6 months prior to screening.
- •Known Human Immunodeficiency Virus (HIV)-positive status.
- •Participated in any interventional clinical trials within 1 month prior to screening.
- •Pregnancy or breast feeding.
结局指标
主要结局
To evaluate PD profile of the test product of albuterol sulfate inhalation aerosol 108 mcg per actuation (equivalent to 90 mcg of albuterol base) and to determine its bioequivalence to the PD profile of RLD in adult patients with stable mild asthma
时间窗: Visit 1 to Visit 5
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 and vital signs (BP, PR, and body temperature).(Screening to Visit 5)
研究者
研究点 (8)
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