疗效,安全性和系统性暴露每天一次的 Indacaterol 乙在儿科喘:一个随机,双盲,受控剂量发现研究
Bulent Enis Sekerel1, Haylene Nell2, Istvan Laki3
1Pediatric Allergy and Asthma Division, Hacettepe University Faculty of Medicine, Ankara, Turkey. b_sekerel@yahoo.com.
Clinical drug investigation
|September 8, 2023
概括
每天服用一次的因达卡特罗酸 (IND) 与莫梅松酸 (MF) 改善了患有喘的儿童的肺功能. 对于进一步的III期试验,建议使用75微克的IND剂量.
科学领域:
- 肺部病理学 肺部病理学
- 儿童喘研究 儿童喘研究
背景情况:
- 长期作用的β2-激动剂英达卡特酸 (IND) 正在与吸入性皮质类固醇 (ICS) 莫梅松酸 (MF) 一起研究,用于儿科喘.
- 这项研究评估了两个IND剂量的有效性,安全性和系统性暴露在患有持续性喘的儿童中.
研究的目的:
- 评估每天服用一次 (75微克和150微克) 的英达卡特酸盐在患有持续性喘的儿童中的疗效和安全性.
- 确定IND的最佳剂量,以便在儿童喘治疗中进一步研究.
主要方法:
- 一项IIb期,随机,双盲,并行组研究,涉及患有持续性喘的儿科患者 (年龄在6至12岁以下).
- 患者每天一次通过Breezhaler®与背景ICS治疗相结合,接受IND 75微克或IND 150微克.
- 主要终点是两周后,与基线相比,剂量前一秒内 (FEV1) 强迫呼气量最低值的变化.
主要成果:
- 两种IND剂量都显著改善了剂前低值FEV1与14日的基线相比.
- 二次螺旋测量参数和喘控制得分也显示出改善.
- 观察到血IND度的剂量依赖性增加,两剂量都具有可接受的安全性.
结论:
- 每天一次的IND 75微克和150微克,与背景ICS相结合,提供了显著的支气管扩张,并且在患有喘的儿童中耐受良好.
- 这些发现支持IND 75μg作为与MF一起使用的儿科喘III期试验中最合适的剂量.
相关概念视频
01:25Antiasthma Drugs: Inhaled Corticosteroids and Glucocorticoids
295
Inhaled corticosteroids (ICS) are anti-inflammatory drugs used primarily in treating persistent asthma and providing long-term maintenance. They target the bronchial mucosa, the lining of the airways, to control inflammation, a critical factor in asthma progression and exacerbation.
ICS work through a multifaceted mechanism of action. They suppress the inflammatory response caused by the proliferation of TH cells. They also reduce the transcription of the IL-2 gene, which is involved in the...
ICS work through a multifaceted mechanism of action. They suppress the inflammatory response caused by the proliferation of TH cells. They also reduce the transcription of the IL-2 gene, which is involved in the...
295
01:30Asthma-IV: Diagnostic and Management
2.5K
The diagnosis and management of asthma are comprehensive, encompassing clinical assessments, lung function tests, and pharmacological interventions. Here's an overview:
Clinical Assessment for Asthma:
This is the first step in diagnosing and managing asthma. It includes:
Clinical Assessment for Asthma:
This is the first step in diagnosing and managing asthma. It includes:
2.5K
01:23Inhaled Medications
305
Inhaled medications are crucial for managing chronic obstructive pulmonary disease (COPD) and asthma. They are essential for effective treatment and control, ensuring optimal respiratory health and well-being. Inhaled medication delivers drugs directly to the lungs, providing a rapid onset of action and reducing systemic side effects compared to oral or injectable medications. Three primary types of inhalation devices are used to administer these medications: nebulizers, metered-dose inhalers...
305
01:19Antiasthma Drugs: Leukotriene Modifiers
343
Leukotriene modifiers, or cysteinyl leukotriene receptor antagonists, are medications used to manage chronic asthma. These agents target specific inflammatory mediators produced during arachidonic acid metabolism, an essential process in generating inflammation in the body.
Leukotriene modifiers work through two distinct mechanisms:
Leukotriene modifiers work through two distinct mechanisms:
343
01:25Antiasthma Drugs: β2-Adrenoceptor Agonists
295
Bronchodilators are critical in managing asthma, a chronic respiratory condition characterized by airway constriction due to inflammation and hyper-reactivity. Specifically, bronchodilators ease this constriction by relaxing the bronchial muscles, facilitating easier breathing.
One class of bronchodilators includes β2-adrenoceptor agonists. These agents target the β2-adrenoceptors located on bronchial smooth muscle cells. By stimulating these receptors, β2-agonists induce...
One class of bronchodilators includes β2-adrenoceptor agonists. These agents target the β2-adrenoceptors located on bronchial smooth muscle cells. By stimulating these receptors, β2-agonists induce...
295
01:24Antiasthma Drugs: Methylxanthines
266
Theophylline, a member of the methylxanthine class of bronchodilators, has long been used in asthma management. While its exact mechanism of action is not fully understood, it is believed to have multiple effects on various cellular processes.
Theophylline is thought to inhibit phosphodiesterase enzymes, increasing intracellular levels of cyclic adenosine monophosphate (cAMP) and cyclic guanosine monophosphate (cGMP). This rise in cAMP and cGMP concentrations stimulates cardiac function,...
Theophylline is thought to inhibit phosphodiesterase enzymes, increasing intracellular levels of cyclic adenosine monophosphate (cAMP) and cyclic guanosine monophosphate (cGMP). This rise in cAMP and cGMP concentrations stimulates cardiac function,...
266