An Open Label Placebo Study To Assess The Inhalation Profile Obtained By Acoustic Monitoring In COPD Patients Using The NEXThaler Dry Powder Inhaler (DPI) Device
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Evaluation of Inhalatory Profile for 80 patients
研究概览
简要总结
Phase IIa, single center, open-label, single-arm study, to evaluate the inspiration profile through the NEXThaler device in adult COPD patients with varying degrees of airflow limitation
详细描述
As this is an exploratory study, a total of 70 to 80 completed patients, ensuring the following distribution in terms of COPD Stage as per GOLD 2013 (updated) spirometric classification of disease severity, are deemed to be sufficient for assessing the inhalation profile through the NEXThaler®:
- 10 to 20 COPD GOLD Stage I patients
- 20 patients in each of the COPD GOLD Stage II to IV. Assuming a screening failure/drop-out rate of 10%, a maximum of 89 patients will be screened in order to reach the required number of completed patients.
All the analyses will be performed separately for the first and the second inhalation. Results stratified by disease severity and overall will be presented.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent obtained from the patient and/or the legal representatives
- •Inpatients and outpatients of both sexes, aged ≥ 40 years
- •Documented clinical diagnosis (within the past 6 months) of COPD with varying degrees of airflow limitation based on Spirometric classification of disease severity according to GOLD 2013 (updated) guidelines with a smoking history of at least 10 pack years (pack-years = the number of cigarette packs per day times the number of years). Current smokers and ex-smokers are eligible
- •A cooperative attitude and ability to use DPIs and to be trained in the proper use of the NEXThaler® as confirmed by the activation of the training device BAM
排除标准
- •Pregnant women confirmed by a positive pregnancy test or nursing (lactating) women (if applicable)
- •Diagnosis of asthma
- •Diagnosis of restrictive lung disease
- •Allergy to any component of the placebo treatment
- •Inability to comply with study procedures or treatment
- •Significant unstable medical history of and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any previously documented laboratory abnormality indicative of a significant underlying condition, that may interfere with patient's safety, compliance, or study evaluations, according to the investigator's opinion.
结局指标
主要结局
Evaluation of Inhalatory Profile for 80 patients
时间窗: Visit 1
The study duration per patient is only one visit. At visit 1 the patient after having signed the ICF and after having assessed the eligibility criteria should perform two evaluable inhalatory manoeuvres through the device instrumented with an acoustic monitoring system (microphone). The sounds captured by the microphone are sent to a PC which acquire it for analysis of the profile. Each manoeuvre lasts few seconds. After having completed the manoeuvres and have the same assessed as good by the Investigator, the study is completed. All the procedures are expected to be performed within a couple of hours for each patient.
次要结局
未报告次要终点