Document is current

Article History

Received: 10 June 2022

Accepted: 11 November 2022

First Online: 5 December 2022

Declarations

:

: This study was originally approved by WUSTL’s IRB on December 8, 2021.This pragmatic real-world study aims to assess in real-life two separate inhaler approaches, which are both FDA approved, and wherein both are advocated for as equally beneficial by the NIH EPR-4 and GINA guidelines. We seek to evaluate if one inhaler approach is considered more efficacious, particularly in maintenance inhaler non-adherent patients. We are aware of no significant ethical concerns. Both women and minority groups are expected to be represented in this study. In adults, asthma disproportionately affects women, and, as such, women are expected to be our majority recruitment population. However, women who are pregnant or planning to become pregnant will be excluded from this study. English-speaking patients from all racial and ethnic groups will be eligible for enrollment. African Americans and the Black community in St. Louis are disproportionately affected by asthma and is expected to be well-represented in this study.Permission for text assessments will be obtained on the phone only. No other interventions whatsoever will take place until written consent is obtained in-person at the first in-person study visit. Patients who do not complete at least 70% of these one-item text assessments will not be invited for the in-person first study visit.During all consents, the individuals will have as much time as needed to consider participation. At the first study visit, if they agree to participate and are eligible, potential participants will then be consented in-person or via Zoom by an approved member of the study team. If potential participants elect to pursue consent over Zoom, we will recommend they seek a quiet private environment, and the process will be similarly treated between the potential participant and research staff as would be the case in-person. The informed consent process will then utilize the approved informed consent document in REDCap (or via paper and pen if in-person and the participant prefers). We will then proceed with study procedures for the first visit.We will make every attempt to minimize the possibility of coercion or undue influence during the consent process. We will make sure to inform the participant of their rights and make sure they feel the consent process is an ongoing process throughout the study with the right to withdraw at any point for any reason or lack thereof.

: Not applicable.

: The PI has served on advisory committees for Genentech and Sanofi/Regeneron.