Evidence map›Paper›PMID 37602889›Full record

ArticleClinical and translational science2023

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

Elena S Izmailova, Rachel Kilian, Jessie P Bakker, Shawna Evans, Anthony D Scotina, Theodore F Reiss, Dave Singh, John A Wagner

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Clinical and translational science, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05757908 (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), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.9field-weighted citation impact, top 26% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05757908 nacompletednot on this map

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)

TypeinterventionalSponsorKoneksa HealthRan2023 to 2023Enrolled29ConditionsModerate AsthmaArmsLong-Acting Beta Agonist
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 5 citations in OpenAlex.

  1. LOTUS Software to Process Wearable EmbracePlus Data.Sensors (Basel, Switzerland) · 2024
    Article
  2. Article
  3. Review
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 4 institutions in 2 countries.

Elena S IzmailovaKoneksa Health, New York, New York, USA.ORCID 0000-0002-7150-1748
Rachel KilianKoneksa Health, New York, New York, USA.
Jessie P BakkerDepartment of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.
Shawna EvansKoneksa Health, New York, New York, USA.
Anthony D ScotinaKoneksa Health, New York, New York, USA.ORCID 0000-0003-1301-3209
Theodore F ReissIndependent Pharmaceutical Consultant, New Hope, Pennsylvania, USA.
Dave SinghMedicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Trust, Manchester, UK.
John A WagnerKoneksa Health, New York, New York, USA.ORCID 0000-0002-0636-5006
Global Strategy Group · USBrigham and Women's Hospital · USManchester University NHS Foundation Trust · GBOldham Council · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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 1 s (FEV1); however, the impact of remote spirometry measurements on the detection of treatment effect has not been investigated. A protocol for a multicenter, single-arm, open-label interventional trial of long-acting beta agonist (LABA) therapy among 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 among participants with moderate asthma, using both clinical spirometry (FEV1

Indexed as

Adrenergic beta-2 Receptor AgonistsAsthmaClinical Trials as TopicForced Expiratory VolumeHumansMulticenter Studies as TopicResearch DesignSpirometryAdrenergic beta-2 Receptor Agonists

Identifiers

PMID37602889
PMCPMC10651656
OpenAlexW4386019615

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.