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
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
29
The Investigator will prescribe standard of care LABA to eligible study participants. Participants will self-administer LABA once or twice 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 and evening at-home mobile Spirometry testing.
AllerVie Research Clinic
Birmingham, Alabama, United States
AllerVie Research Clinic
Columbus, Georgia, United States
Northeast Medical Research Associates, Inc.
North Dartmouth, Massachusetts, United States
The Asthma & Allergy Center, PC
Bellevue, Nebraska, United States
American Health Research
Charlotte, North Carolina, United States
Clinical Research of Rock Hill
Rock Hill, South Carolina, United States
Spartanburg Medical Research
Spartanburg, South Carolina, United States
El Paso Pulmonary Association
El Paso, Texas, United States
South Texas Allergy & Asthma Medical Professionals Research
San Antonio, Texas, United States
Measured FEV1 Change to Treatment Effect
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
Time frame: Baseline Day 1 through Day 43 End of Study
Measured FEV1 Change and Comparison of Variability
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
Time frame: Baseline Day 1 through Day 43 End of Study
Mobile Spirometry Compliance
Percentage of compliance for once and twice daily at-home mSpirometry
Time frame: Baseline Day 1 through Day 43 End of Study
Relationship Between In-clinic and Mobile Spirometry Parameters
1. Evaluate the relationship between in-clinic and mSpirometry FEV1 and other Spirometry parameters (e.g., FVC) 2. Relationship between other Spirometry measurements (e.g., FVC)
Time frame: Baseline Day 1 through Day 43 End of Study
Diurnal Differences in Mobile Spirometry
Diurnal differences in morning versus evening for at-home mSpirometry parameters, e.g., FEV1
Time frame: Baseline Day 1 through Day 43 End of Study
Time to Treatment Effect
Time to treatment effect detection using at-home mSpirometry via change in FEV1
Time frame: Baseline Day 1 through Day 43 End of Study
Treatment Effect
Treatment effect as measured by change from baseline in ACQ-6
Time frame: Baseline Day 1 through Day 43 End of Study
Mobile Spirometry Changes
Relationship between at-home mSpirometry changes and changes in ACQ-6
Time frame: Baseline Day 1 through Day 43 End of Study
Device Use Surveys
1. Site clinical care team likelihood to recommend at-home mSpirometry 2. Site clinical care team ease-of-use of at-home mSpirometry 3. Site clinical care team device satisfaction 4. Participant likelihood to recommend at-home mSpirometry 5. Participant ease-of-use of at-home mSpirometry 6. Participant device satisfaction
Time frame: Baseline Day 1 through Day 43 End of Study
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.