Study protocol: A comparison of mobile and clinic‐based spirometry for capturing the treatment effect in moderate asthma

Abstract

Several inefficiencies in drug development trial implementation may be improved by moving data collection from the clinic to mobile, allowing for more frequent measurements and therefore increased statistical power while aligning to a patient‐centric approach to trial design. Sensor‐based digital health technologies such as mobile spirometry (mSpirometry) are comparable to clinic spirometry for capturing outcomes such as forced expiratory volume in one second (FEV1); however, the impact of remote spirometry measurements on the detection of treatment effect has not been investigated. A protocol for a multi‐center, single‐arm, open‐label interventional trial of long‐acting beta agonist (LABA) therapy amongst 60 participants with uncontrolled moderate asthma is described. Participants will complete twice‐daily mSpirometry at home and clinic spirometry during weekly visits, alongside continuous use of a wrist‐worn wearable and regular completion of several diaries capturing asthma symptoms as well as participant‐ and site‐reported satisfaction and ease of use of mSpirometry. The co‐primary objectives of this study are A) to quantify the treatment effect of LABA therapy amongst participants with moderate asthma, using both clinical spirometry (FEV1c) and mSpirometry (FEV1m); and B) to investigate whether FEV1m is as accurate as FEV1c in detecting the treatment effect using a mixed‐effect model for repeated measures. Study results will help inform whether the deployment of mSpirometry and a wrist‐worn wearable for remote data collection is feasible in a multi‐center setting amongst participants with moderate asthma, which may then be generalizable to other populations with respiratory disease.

Moving the Needle for Oncology Dose Optimization: A Call for Action

“…In the context of dose optimization, characterizing the underlying exposure–response relationship for on‐treatment ctDNA dynamics to inform definition of a clinically active dose range represents an untapped opportunity. Another important innovation has been in the area of digital health technologies such as a proposed multidomain, digital model for capturing functional status, and health‐related quality of life in oncology, 22 which can be particularly relevant to realize the promise of Project Optimus aimed at dosage optimization for improved quality of life during long‐term therapy.…”

Moving the needle for oncology dose optimization: A call for action

“…In the context of dose optimization, characterizing the underlying exposure-response relationship for on-treatment ctDNA dynamics to inform the definition of a clinically active dose range represents an untapped opportunity. Another important innovation has been in the area of digital health technologies such as a proposed multidomain, digital model for capturing functional status and health-related quality of life in oncology, 22 which can be particularly relevant to realize the promise of Project Optimus aimed at dosage optimization for improved quality of life during long-term therapy. ASCPT, clinical pharmacologists, and translational scientists have a key role in collaboration on dose optimization challenges and opportunities across different stakeholders.…”