LEARN: Study Comparing At-Home Mobile Spirometry to In-Clinic in Moderate Asthma Participants Taking Long-Acting Beta Agonist
Study Details
Study Description
Brief Summary
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:
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Do at-home mobile spirometry and in-clinic spirometry assessments show a similar treatment effect (measured changes in FEV1) with the addition of LABA?
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Is at-home mobile spirometry as accurate as in-clinic spirometry in showing treatment effects (changes in FEV1)?
Participants will be asked to:
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Take standard of care LABA treatment once a day
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Complete at-home mobile spirometry testing twice a day
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Complete asthma questionnaires twice a day
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Complete device use questionnaires
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Wear a wrist device (like a watch) to track physical activity and vital signs
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Visit the clinic for in-clinic spirometry testing once a week for 8 weeks
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
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 6-week interventional assessment period consisting of addition of LABA, for an estimated participant duration of 8 weeks.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Long-Acting Beta Agonist Standard of care LABA |
Drug: Long-Acting Beta Agonist
The Investigator will prescribe standard of care LABA to eligible study participants. Standard of care includes but is not limited to: Vilanterol (25 mcg daily). Participants will self-administer LABA once daily at the maximum feasible standard of care dosage, per the time points specified in the study Schedule of Assessments. LABA should be taken within 1 to 3 hours prior to morning at-home mobile Spirometry testing.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Measured FEV1 Change to Treatment Effect [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
Secondary Outcome Measures
- Measured FEV1 Change and Comparison of Variability [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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female between 18 years and 65 years of age inclusive
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Body mass index (BMI) 18 - 35 mg/m2 inclusive
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Participant with a diagnosis of moderate uncontrolled asthma for a period of at least 2 years prior to screening
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Participant must be using a medium daily dose of inhaled corticosteroids (ICS)
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Asthma that is not currently using long-acting beta-agonists (LABA), (ICS score of 0.75 or higher)
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Pre-bronchodilator FEV1 ≥ 60% and ≤100% of the predicted normal values at screening
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A documented positive response to the reversibility test at the screening, defined as improvement in FEV1 ≥ 12% and ≥ 200 mL over baseline after 400μg salbutamol pressurized metered-dose inhalers (pMDI)
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Participant is judged to be in good health based on medical history, physical examination, and vital sign measurements
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Non-smokers or ex-smokers with a cumulative tobacco exposure less than 5 pack- years and who have stopped smoking more than 1 year ago (pack-year: number of cigarettes smoked per day multiplied by the number of years of smoking divided by 20)
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Women of childbearing potential must have a negative urine pregnancy test before enrolling at Baseline Day 1
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Participant demonstrated ability to perform satisfactory in-clinic and at-home Spirometry according to ATS/ERS standards (Graham 2019), as well as the mobile application to synchronize Spirometry data collection and respond to questionnaires during the Screening coaching/training period
Exclusion Criteria:
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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
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Occurrence of asthma exacerbations or respiratory tract infections within 4 weeks prior to Screening
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History of substance abuse in the last 6 months, excluding medical or recreational non- inhaled marijuana
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Currently taking other biologics to control asthma symptoms (allergy shots are acceptable)
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Diagnosis of any other airway/pulmonary disease such as Chronic Obstructive Pulmonary Disease (COPD) as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines (updated 2013); 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)
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Clinically unstable participants
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Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals within 1 month prior to screening
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Participant has a history of neoplastic disease. Exception (1) participant with an adequately treated basal cell carcinoma or carcinoma in situ of the cervix may participate; (2) participants with other malignancies which have been successfully treated > 10 years prior to screening without evidence of recurrence
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Participants treated with oral or parenteral corticosteroids in the previous 4-6 weeks (12 weeks for parenteral depot corticosteroids) prior to screening
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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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Koneksa Health
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KH008