Home monitoring of patients with cystic fibrosis to identify and treat acute pulmonary exacerbations. eICE study results
Open accessAbstract
Abstract Rationale Individuals with cystic fibrosis (CF) experience frequent acute pulmonary exacerbations, which lead to decreased lung function and reduced quality of life. Objectives The goal of this study was to determine if an intervention directed toward early detection of pulmonary exacerbations using home spirometry and symptom monitoring would result in slower decline in lung function than in control subjects. Methods We conducted a multicenter, randomized trial at 14 CF centers with subjects at least 14 years old. The early intervention arm subjects measured home spirometry and symptoms electronically twice per week. Sites were notified if a participant met criteria for an exacerbation and contacted participants to determine if treatment for acute exacerbation was required. Participants in the usual care arm were seen every 3 months and were asked to contact the site if they were concerned about worsening pulmonary symptoms. Measurements and Main Results The primary outcome was the 52-week change in FEV1. Secondary outcomes included time to first exacerbation and subsequent exacerbation, quality of life, and change in weight. A total of 267 patients were randomized, and the study arms were well matched at baseline. There was no significant difference between study arms in 52-week mean change in FEV1 slope (mean slope difference, 0.00 L, 95% confidence interval, −0.07 to 0.07; P = 0.99). The early intervention arm subjects detected exacerbations more frequently than usual care arm subjects (time to first exacerbation hazard ratio, 1.45; 95% confidence interval, 1.09 to 1.93; P = 0.01). Adverse events were not significantly different between treatment arms. Conclusions An intervention of home monitoring among patients with CF was able to detect more exacerbations than usual care, but this did not result in slower decline in lung function. Clinical trial registered with www.clinicaltrials.gov (NCT01104402).
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In the eICE multicentre randomised trial, more pulmonary exacerbations were detected in the intervention arm than in standard care.
“More PEx were detected in the intervention arm, but there was no difference between groups in lung function decline (16).”
From Virtual monitoring in CF – the importance of continuous monitoring in a multi-organ chronic condition (2023) · cites this paper as [16]
In the eICE trial, there was no difference between groups in lung function decline.
“More PEx were detected in the intervention arm, but there was no difference between groups in lung function decline (16).”
From Virtual monitoring in CF – the importance of continuous monitoring in a multi-organ chronic condition (2023) · cites this paper as [16]
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References 30 · Cited by 127
Research works printed but not linked: 3
- [2]Cystic Fibrosis Foundation. Bethesda, MD: Cystic Fibrosis Foundation; 2014. Cystic Fibrosis Foundation patient registry: 2013 annual report. [Google Scholar]
- [11]Schechter MS, Leonard A, Nash J, Quinton HB, Richards K, Sabadosa K, VandenBranden S. Benchmarking: signature themes. Pediatr Pulmonol. 2006;41:122–123. [Google Scholar]
- [29]Goss CH. Early intervention in pulmonary exacerbation [abstract] Pediatr Pulmonol. 2011;46:A331. [Google Scholar]
- Authors
- Lechtzin, N., Mayer-Hamblett, N., West, N. E., Allgood, S., Wilhelm, E., Khan, U., Aitken, M. L., Ramsey, B. W., Boyle, M. P., Mogayzel, P. J., Gibson, R. L., Orenstein, D., Milla, C., Clancy, J. P., Antony, V., & Goss, C. H.
- Affiliations
- Johns Hopkins University (US)
- Seattle Children's Hospital (US)
- University of Washington (US)
- University of Pittsburgh (US)
- Stanford Medicine (US)
- University of Cincinnati (US)
- University of Alabama at Birmingham (US)
- Corresponding author
- Goss, Christopher H.
- ORCID
- Venue
- American Journal of Respiratory and Critical Care Medicine
- Publisher
- Oxford University Press (OUP)
- Published
- 2017-11-01
- Volume
- 196
- Issue
- 9
- Pages
- 1144-1151
- ISSN
- 1073-449X (ISSN-L)
- 1535-4970
- PMC
- PMC5694835
- OpenAlex
- W2625491143
- Cited by
- 127
- References
- 30
- Citations by year
- 2026: 8 · 2025: 6 · 2024: 9 · 2023: 19 · 2022: 18 · 2021: 27 · 2020: 12 · 2019: 11 · 2018: 13 · 2017: 3
- FWCI
- 8.75
- Type
- journal article
- Language
- en
- Open access
- green
- europepmc.org
- Locations
- American Journal of Respiratory and Critical Care Medicine (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Cystic Fibrosis Foundation (UM1HL119073, P30 DK089507)
- Cystic Fibrosis Foundation Therapeutics
- National Institutes of Health
- U.S. Food and Drug Administration (R01 FD003704)
- National Heart, Lung, and Blood Institute (R01HL113382, UM1HL119073, R01HL103965, R15HL126122, T32HL072748)
- National Institute of Allergy and Infectious Diseases (R01AI101307)
- National Institute of Diabetes and Digestive and Kidney Diseases (P30DK089507)
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Cystic Fibrosis Research Advances
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Chronic Obstructive Pulmonary Disease (COPD) Research
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Inhalation and Respiratory Drug Delivery
- Keywords
- cystic fibrosis, pulmonary exacerbations, home spirometry, home monitoring, lung function decline, FEV1, symptom monitoring, quality of life
- MeSH terms
- Adult, Cystic Fibrosis, Female, Forced Expiratory Volume, Humans, Lung, Male, Self Care, Spirometry
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