Utilizing Advances in Digital Inhaler Technology to Understand Heterogeneous Treatment Responses to Biologics in Severe Asthma
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Mean Number of Daily Doses of ProAir® Digihaler™
研究概览
简要总结
This trial is being completed to determine baseline inhalation parameters and patterns of use in patients receiving treatment with TEVA digital inhalers, to develop predictive models for asthma exacerbations and response to biologics using data collected from these devices.
Enrolled participants will complete questionnaires along with other study specific procedures. Additionally, in-person and phone visits will be performed.
详细描述
All participants were provided an AirDuo® Digihaler™ and ProAirDuo® Digihaler™, which the participants could choose to use or not. This trial did not restrict participants from using other asthma treatments in addition to or in lieu of the Digihalers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A history of severe persistent asthma as defined by European Respiratory Society (ERS) and American Thoracic Society (ERS/ATS) criteria which includes the presence of poor asthma control on high dose inhaled corticosteroid (ICS) and a long-acting beta-agonist (CS/LABA) or the need for high dose ICS/LABA to maintain asthma control or oral steroids for maintenance therapy for more than 50% of the prior year.
- •Presence of current biologic use or planned initiation of biologics following study enrollment
- •Patients will be categorized on the basis of asthma control (Asthma Control Test (ACT)< 19 will be considered poor asthma control). The study will cap the patients with good asthma control at 30% and will no longer enroll those patients once the strata have been fully enrolled.
- •Willingness to switch maintenance inhalers to AirDuo® Digihaler™ and to use ProAir® Digihaler™ for rescue therapy. Use of nebulized albuterol will be discouraged but not prohibited.
- •Can read and communicate in English and is familiar with and is willing to use his/her own smart device and download and use the study application
- •Ability to provide informed consent.
- •The patient must be willing and able to comply with study requirements and restrictions
排除标准
- •Clinically important pulmonary disease other than asthma including Chronic obstructive pulmonary disease (COPD), bronchiectasis, pulmonary fibrosis, cystic fibrosis, or other lung disease
- •Any disorder that is either not stable or could in the opinion of the investigator affect the ability of the subject to safely participate in the study or could adversely affect study results.
- •History of human immunodeficiency virus or other immunodeficiency syndrome
- •Malignancy other than skin cancer that has occurred within the past year and that will impact survival thus limit participation in the clinical trial
- •History of chronic alcohol abuse or drug use
- •Any life-threatening diseases that will impact the patient's ability to complete the 12-month study period
结局指标
主要结局
Mean Number of Daily Doses of ProAir® Digihaler™
时间窗: up to 1 year
This outcome measured participant adherence to using the ProAir® Digihaler™. All participants were provided the Digihaler device, which they could choose to use or not. Subject-specific result was calculated as the sum total of doses taken by participant divided by their number of days of follow-up.
Mean Number of Daily Doses AirDuo® Digihaler™.
时间窗: up to 1 year
This outcome measured participant adherence to using the AirDuo® Digihaler™. All participants were provided the Digihaler, which they could choose to use or not. Subject-specific result was calculated as the sum total of doses for a given participant divided by their number of days of follow-up.
Median Number of Daily Doses of ProAir® Digihaler™
时间窗: up to 1 year
This outcome measured participant adherence to using the ProAir® Digihaler™. All participants were provided the Digihaler, which they could choose to use or not. Subject-specific result was calculated as the 50th percentile value of all daily dose totals (or the average of two 50th percentile values if there was a tie) calculated over the number of days of follow-up.
Median Number of Daily Doses of AirDuo® Digihaler™
时间窗: up to 1 year
This outcome measured participant adherence to using the AirDuo® Digihaler™. All participants were provided the Digihaler, which they could choose to use or not. Subject-specific result was calculated as the 50th percentile value of all daily dose totals (or the average of two 50th percentile values if there was a tie) calculated over the number of days of follow-up.
Median Number of Daily Doses of ProAir® Digihaler™
时间窗: up to 1 year
This outcome measured participant adherence to using the ProAir® Digihaler™. All participants were provided the Digihaler, which they could choose to use or not. Subject-specific result was calculated as the 50th percentile value of all daily dose totals (or the average of two 50th percentile values if there was a tie) calculated over the number of days of follow-up.
Mean Number of Daily Doses of ProAir® Digihaler™
时间窗: up to 1 year
This outcome measured participant adherence to using the ProAir® Digihaler™. All participants were provided the Digihaler device, which they could choose to use or not. Subject-specific result was calculated as the sum total of doses taken by participant divided by their number of days of follow-up.
Mean Number of Daily Doses AirDuo® Digihaler™.
时间窗: up to 1 year
This outcome measured participant adherence to using the AirDuo® Digihaler™. All participants were provided the Digihaler, which they could choose to use or not. Subject-specific result was calculated as the sum total of doses for a given participant divided by their number of days of follow-up.
Median Number of Daily Doses of AirDuo® Digihaler™
时间窗: up to 1 year
This outcome measured participant adherence to using the AirDuo® Digihaler™. All participants were provided the Digihaler, which they could choose to use or not. Subject-specific result was calculated as the 50th percentile value of all daily dose totals (or the average of two 50th percentile values if there was a tie) calculated over the number of days of follow-up.
次要结局
- Maintenace Inhaler Adherence Rates(up to 1 year)
- Participants Who Achieved Non-response, Partial Response, and Complete Response to Biologics(up to 1 year)
- Change in Mean Peak Inhalation Volume(baseline to 1 year)
- Change in Mean Inspiratory Time(baseline to 1 year)
- Change in Mean Peak Inspiratory Flow (PIF)(baseline up to 1 year)
- Change in Mean Forced Expiratory Volume in One Second (FEV1)(baseline up to 1 year)
- Maintenace Inhaler Adherence Rates(up to 1 year)
- Participants Who Achieved Non-response, Partial Response, and Complete Response to Biologics(up to 1 year)
- Change in Mean Peak Inhalation Volume(baseline to 1 year)
- Change in Mean Inspiratory Time(baseline to 1 year)
- Change in Mean Peak Inspiratory Flow (PIF)(baseline up to 1 year)
- Change in Mean Forced Expiratory Volume in One Second (FEV1)(baseline up to 1 year)
研究者
Njira Lugogo
Associate Professor of Internal Medicine
University of Michigan