NCT00130351已完成3 期
A 3-week Multicenter Study Investigating Patient Use and Functionality of Formoterol in a Novel Inhalation Device in Patients With Asthma
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 155
- 试验地点
- 23
- 主要终点
- Device use: Patients were instructed to record the number appearing in the dose counter window after their dose on the diary card.
研究概览
简要总结
This study is designed to investigate the ability of patients with asthma to properly use a new multi-dose dry powder inhaler (MDDPI) device in a real-life situation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are capable of understanding the directions for device usage, evaluating device function and completing the patient diary
- •Patients who have a current diagnosis of asthma
- •Patients who have a documented forced expiratory volume at 1 second (FEV1) reversibility of at least 12% over baseline value following administration of a bronchodilator (i.e. "historical" reversibility) or demonstrate a >12% increase in FEV1 over their baseline value within 30 minutes after inhalation of up to 360 µg (4 puffs) of albuterol at Visit
- •The administration of albuterol for the reversibility test must be within 30 minutes after baseline spirometry.
排除标准
- •Patients who were enrolled in study CFOR258F2304 or CFOR258F2306, or who have any experience using the Certihaler® device.
- •QTc above 450 milliseconds for males and 470 milliseconds for females, or any findings on the screening electrocardiogram (ECG) that in the opinion of the investigator would present a safety hazard for continuation in the study
- •Patients who have a known history of untoward reactions to sympathomimetic amines or to inhaled medications or to any of the individual components in those therapies
- •Other protocol-defined inclusion and exclusion criteria apply
结局指标
主要结局
Device use: Patients were instructed to record the number appearing in the dose counter window after their dose on the diary card.
Safety: Assessed by adverse events, physical examinations, vital signs abnormalities, forced expiratory volume in 1 second (FEV1) and screening ECG.
次要结局
未报告次要终点
研究者
研究点 (23)
Loading locations...
相似试验
已完成
不适用
An Observational Study to Investigate How Patients Experience the Ability to Adjust Their Asthma Maintenance MedicationAsthmaNCT00577265AstraZeneca
进行中（未招募）
不适用
An Observational, Prospective, Multicenter Study to Evaluate the Biologic Use and Outcomes in Chinese Asthma PatientsAsthmaNCT06605885AstraZeneca202
已完成
3 期
A Long-term Safety Study of Fixed Dose Combination Therapy Fluticasone Furoate/Umeclidinium Bromide/Vilanterol Trifenatate in Japanese Subjects With AsthmaAsthmaNCT03184987GlaxoSmithKline111
已完成
4 期
A Comparison of Critical Errors, Overall Errors, Training/Teaching Time, and Preference Attributes of the ELLIPTA Versus BREEZHALER Dry Powder Inhalers (DPIs) in Adult Participants With AsthmaAsthmaNCT04813354GlaxoSmithKline114
已完成
1 期
A Study to Assess the Efficacy of Inhaled Corticosteroid (ICS) Therapy in Moderate-Severe Bronchial AsthmaBronchial AsthmaNCT00411567Novartis26