An Open-Label, Single-Arm Study in Moderate Asthma Participants Comparing the Treatment With Long-Acting Beta Agonist Between At-Home Mobile Spirometry and In-Clinic Spirometry (LEARN)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 8
- 主要终点
- Measured FEV1 Change to Treatment Effect
研究概览
简要总结
The goal of this interventional study is to compare at-home mobile spirometry to in-clinic spirometry in participants with moderate asthma while taking a long-acting beta agonist (LABA).
The main questions it aims to answer are:
- Do at-home mobile spirometry and in-clinic spirometry assessments show a similar treatment effect (measured changes in FEV1) with the addition of LABA?
- Is at-home mobile spirometry as accurate as in-clinic spirometry in showing treatment effects (changes in FEV1)?
Participants will be asked to:
- Take standard of care LABA treatment once or twice a day
- Complete at-home mobile spirometry testing twice a day
- Complete asthma questionnaires twice a day
- Complete device use questionnaires
- Wear a wrist device (like a watch) to track physical activity and vital signs
- Visit the clinic for in-clinic spirometry testing once a week for 8 weeks
详细描述
The study will recruit up to 60 participants with moderate uncontrolled asthma who are taking inhaled corticosteroids (ICS) at the time of study enrollment but will require LABA treatment as judged by their treating physician. The study will assess the LABA treatment effect in clinic and mobile spirometry, assess the relationship between different readouts of mobile spirometry in addition to assessing asthma control as measured by ACQ-6, patient reported outcome questionnaire. Additional objectives include an evaluation of patient and site-specific satisfaction with mobile spirometry technology.
The study consists of a one-week screening period, one-week baseline period, and up to 6-week interventional assessment period consisting of addition of LABA, for an estimated participant duration of 8 weeks.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals 18 years or older
- •Body mass index (BMI) 18 - 40 mg/m2 inclusive
- •Participant with a diagnosis of moderate uncontrolled asthma
- •Participant must be using a medium to high daily dose of inhaled corticosteroids (ICS) for a minimum of 6 weeks prior to screening
- •Asthma that is not currently using long-acting beta-agonists (LABA) or log-acting muscarinic antagonist (LAMA) (ACQ score of 0.75 or higher) Note: A 2-week LABA/LAMA washout period is allowed prior to screening
- •Pre-bronchodilator FEV1 ≥ 60% and ≤100% of the predicted normal values at screening
- •A documented positive response to the reversibility test at screening, defined as improvement in FEV1 ≥ 12% and ≥ 200 mL over baseline after a Short Acting Beta Agonist (SABA) standard of care dose. Documented historical reversibility of up to 6 weeks is allowed.
- •Participant is judged to be in good health based on medical history, physical examination, and vital sign measurements
- •Non-smokers or ex-smokers (including vape or inhaled cannabis) who have stopped smoking more than 1 year ago
- •Women of childbearing potential must have a negative urine pregnancy test before enrolling at Baseline Day 1
- •Participant demonstrated ability to perform satisfactory in-clinic and at-home Spirometry according to ATS/ERS standards, as well as the mobile application to synchronize Spirometry data collection and respond to questionnaires during the Screening coaching/training period
排除标准
- •History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest and/or hypoxic seizures or hospitalization (including ER visits) for the treatment of asthma within 3 months prior to screening, or have been hospitalized or have attended the ER for asthma more than twice in prior 6 months
- •Occurrence of asthma exacerbations or respiratory tract infections within 4 weeks prior to Screening
- •History of substance abuse in the last 6 months, excluding medical or recreational non- inhaled marijuana
- •Currently taking other biologics to control asthma symptoms (allergy shots are acceptable)
- •Diagnosis of any other airway/pulmonary disease such as Chronic Obstructive Pulmonary Disease (COPD) as defined by the current Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines; or other lung diseases (e.g., emphysema, idiopathic pulmonary fibrosis, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency or restrictive lung disease)
- •Clinically unstable participants or history of non-compliance as assessed by the PI
- •Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals within 1 month prior to screening
- •Participant has a history of neoplastic disease. Exceptions: Participants with (1) an adequately treated basal or squamous cell carcinoma or carcinoma in situ of the cervix; (2) localized or regional prostate cancer; other malignancies which have been successfully treated > 5 years prior to screening without evidence of recurrence may participate
- •Participants treated with oral or parenteral corticosteroids in the previous 4 weeks prior to screening
- •You may not be able to participate in this study if you have been in another investigational drug study for 30 days prior to this study unless approval is given from the Sponsor. Additionally, you cannot be involved in another investigational drug study during your participation in this study.
研究组 & 干预措施
Long-Acting Beta Agonist
Standard of care LABA
干预措施: Long-Acting Beta Agonist (Drug)
结局指标
主要结局
Measured FEV1 Change to Treatment Effect
时间窗: Baseline Day 1 through Day 43 End of Study
Detection of treatment effect as measured by change from baseline in morning FEV1 measured in change over time for at-home mobile and in-clinic Spirometry
Measured FEV1 Change and Comparison of Variability
时间窗: Baseline Day 1 through Day 43 End of Study
Change from baseline and comparison of variability (measured via confidence interval) in morning FEV1 for at-home morning mSpirometry compared to morning in-clinic Spirometry
次要结局
- Mobile Spirometry Compliance(Baseline Day 1 through Day 43 End of Study)
- Diurnal Differences in Mobile Spirometry(Baseline Day 1 through Day 43 End of Study)
- Device Use Surveys(Baseline Day 1 through Day 43 End of Study)
- Treatment Effect(Baseline Day 1 through Day 43 End of Study)
- Relationship Between In-clinic and Mobile Spirometry Parameters(Baseline Day 1 through Day 43 End of Study)
- Time to Treatment Effect(Baseline Day 1 through Day 43 End of Study)
- Mobile Spirometry Changes(Baseline Day 1 through Day 43 End of Study)