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

NCT05757908 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2024-05-03

No results posted yet for this study

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

Conditions

  • Moderate Asthma

Interventions

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.

Sponsors & Collaborators

  • Koneksa Health

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-21
Primary Completion
2023-11-29
Completion
2023-11-29

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05757908 on ClinicalTrials.gov