Health Effects of CREON2000 In Asthmatic Children

CREON2000 对哮喘儿童的健康影响

• 批准号: 7587024
• 负责人: Mark Glazman
• 金额: $ 22.47万
• 依托单位: GENERAL INNOVATIONS AND GOODS, INC.
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-04-03 至 2010-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7587024
• 关键词: Adjuvant Therapy; Age; Agonist; Air; Allergic; Area; Asthma; Biometry; Budgets; Case Report Form; Chest; Child; Childhood Asthma; Clinical; Clinical Protocols; Clinical Research; Clinical Trials; Clinical Trials Design; Consent Forms; Data; Deterioration; Development; Devices; Diagnosis; Documentation; Double-Blind Method; Duct (organ) structure; Electronics; Enrollment; Ensure; Environmental Exposure; Environmental air flow; Extrinsic asthma; Funding; Grant; Guidelines; Health; Home environment; Hypersensitivity; Intervention; Laboratories; Life; Maintenance; Manuals; Marketing; Measures; Methodology; Monitor; National Institute of Allergy and Infectious Disease; Office for Human Research Protections; Operative Surgical Procedures; Outcome; Pamphlets; Patients; Pharmaceutical Preparations; Phase; Physicians; Placebo Control; Placebos; Preparation; Protocols documentation; Pulmonary Function Test/Forced Expiratory Volume 1; Quality Control; Questionnaires; Reading; Reporting; Research Design; Research Personnel; Respiratory physiology; Safety; Sampling; Severities; Shortness of Breath; Signal Transduction; Site; Small Business Innovation Research Grant; Symptoms; System; Technology; Testing; Time; Training; U-Series Cooperative Agreements; Validation; Work; airborne allergen; asthma inhaler; authority; clinically significant; cost; cost effective; data management; design; diaries; environmental intervention; improved; irradiation; microorganism; multidisciplinary; photonics; prevent; programs; pulmonary function; randomized placebo controlled trial; respiratory; success; ultraviolet; ultraviolet irradiation

DESCRIPTION (provided by applicant): The CREON2000 Photonic system is a high-efficiency ultraviolet air irradiation device. In a study funded by a Phase I SBIR grant, the CREON 2000 installed in the homes of children with allergic asthma was found to significantly improve pulmonary function (reduced Peak Flow variability (PEFRvar), increase Forced Expiratory Volume in 1 second (FEV1), and to reduce asthma medication use and symptom severity (shortness of breath, chest tightness, and number of days with symptoms) compared to a placebo sham unit. This NIAID Clinical Trial Planning Grant (R34) will allow for the development of a detailed clinical protocol designed to definitively demonstrate the efficacy of the CREON2000 in the treatment of mild to moderate persistent allergic asthma in children. The R34 grant will fund the complete planning of all phases of the clinical trial including development of materials that are in accordance with an ICH-compliant program that could enable FDA Pre-Market approval (PMA) of the CREON2000 as a Class 3 device for adjuvant therapy in the management of childhood asthma. The Clinical Trial Planning Team has extensive expertise in design and execution of clinical trials of this type, indoor environmental exposure assessment, and biostatistics. The PI and Co-PI will work closely with their team of experts to develop all documentation required for obtaining an NIAID Clinical Trial Implementation Cooperative Agreement (U01). The study design will be a placebo-controlled, double-blind, parallel group trial in children (ages 8 to 14) with mild to moderate persistent allergic asthma that uses the Asthma Control Questionnaire (ACQ) as the primary endpoint. Secondary endpoints will include home PEFR/FEV1 readings using a Piko-1 electronic device that captures and stores up to 90 readings, the asthma control diary, asthma symptom scores, asthma exacerbations, total asthma controller, and rescue medication use. The protocol design will be kept as simple as possible to maximize the number of patients that can be enrolled, thereby increasing the likelihood that a clinically and statistically significant signal can be detected. Investigating simple and cost-effective technology for improving asthma control in children is consistent with the objectives of the newly revised NAEPP guidelines. We believe that this application and the subsequent clinical trial, if funded, has important ramifications in understanding the effect of in-home central duct UV irradiation systems as a tertiary environmental intervention for the treatment of asthma.

描述（由申请人提供）：CREON 2000 Photonic系统是一种高效紫外线空气辐照装置。在一项由SBIR第一阶段拨款资助的研究中，发现在过敏性哮喘儿童家中安装的CREON 2000可显著改善肺功能（降低峰流量变异性（PEFRvar），增加1秒用力呼气量（FEV 1），并减少哮喘药物使用和症状严重程度（呼吸短促、胸闷和症状天数）。该NIAID临床试验计划补助金（R34）将允许制定详细的临床方案，旨在明确证明CREON 2000治疗儿童轻度至中度持续过敏性哮喘的疗效。 R34赠款将资助临床试验所有阶段的完整规划，包括根据ICH合规计划开发材料，该计划可以使CREON 2000作为儿童哮喘管理辅助治疗的3类器械获得FDA上市前批准（PMA）。临床试验计划团队在设计和执行此类临床试验、室内环境暴露评估和生物统计学方面拥有广泛的专业知识。PI和Co-PI将与其专家团队密切合作，以制定获得NIAID临床试验实施合作协议（U 01）所需的所有文件。研究设计将是一项在轻度至中度持续性过敏性哮喘儿童（8至14岁）中进行的安慰剂对照、双盲、平行组试验，使用哮喘控制问卷（ACQ）作为主要终点。次要终点将包括使用Piko-1电子设备采集并存储多达90个读数的家庭PEFR/FEV 1读数、哮喘控制日记、哮喘症状评分、哮喘急性发作、总哮喘控制器和急救药物使用。方案设计将尽可能简单，以最大限度地增加可入组的患者数量，从而增加检测到临床和统计学显著信号的可能性。调查简单和成本效益的技术，以改善儿童哮喘控制是符合新修订的NAEPP指南的目标。我们相信，如果获得资助，这项应用和随后的临床试验将对了解家用中央管道紫外线照射系统作为治疗哮喘的三级环境干预的效果产生重要影响。