NCT05757908

Study Comparing At-Home Mobile Spirometry to In-Clinic in Moderate Asthma Participants Taking Long-Acting Beta Agonist

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Koneksa Health · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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: * 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

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 up to 6-week interventional assessment period consisting of addition of LABA, for an estimated participant duration of 8 weeks.

Conditions

• Moderate Asthma

Interventions

Type	Name	Description
DRUG	Long-Acting Beta Agonist	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.

Timeline

• Start date: 2023-04-21
• Primary completion: 2023-11-29
• Completion: 2023-11-29
• First posted: 2023-03-07
• Last updated: 2024-05-03

Locations

9 sites across 1 country: United States