Trial reportThe Lancet. Respiratory medicine2023
Discontinuation versus continuation of hypertonic saline or dornase alfa in modulator treated people with cystic fibrosis (SIMPLIFY): results from two parallel, multicentre, open-label, randomised, controlled, non-inferiority trials.
Trial report in The Lancet. Respiratory medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 60 papers, 3 of them syntheses that pooled 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.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
60 citing papers in PubMed, 3 syntheses or guidelines pooled it, 117 citations in OpenAlex.
- Mucoactive agents in bronchiectasis: a systematic review and meta-analysis.European respiratory review : an official journal of the European Respiratory Society · 2026Pooled it
- Ivacaftor-tezacaftor-elexacaftor, tezacaftor-ivacaftor and lumacaftor-ivacaftor for treating cystic fibrosis: a systematic review and economic evaluation.Health technology assessment (Winchester, England) · 2025Pooled it
- Nebulised hypertonic saline for cystic fibrosis.The Cochrane database of systematic reviews · 2023Pooled it
- Vanzacaftor-tezacaftor-deutivacaftor versus elexacaftor-tezacaftor-ivacaftor in individuals with cystic fibrosis aged 12 years and older (SKYLINE Trials VX20-121-102 and VX20-121-103): results from two randomised, active-controlled, phase 3 trials.The Lancet. Respiratory medicine · 2025Trial
- Impact of Discontinuing Both Hypertonic Saline and Dornase Alfa after Elexacaftor-Tezacaftor-Ivacaftor in Cystic Fibrosis.Annals of the American Thoracic Society · 2024Trial
- The effect of discontinuing hypertonic saline or dornase alfa on mucociliary clearance in elexacaftor/tezacaftor/ivacaftor treated people with cystic fibrosis: The SIMPLIFY-MCC Study.Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society · 2024Trial
- Adjunctive Systemic Corticosteroids for Pulmonary Exacerbations of Cystic Fibrosis.Annals of the American Thoracic Society · 2024Trial
- Long-term effectiveness and safety of cystic fibrosis transmembrane conductance regulator modulators and their impact on the lives of people with cystic fibrosis.American journal of respiratory and critical care medicine · 2026Article
- Improvement of the Purification Process for Earthworm DNase and Cytotoxicity Analysis.The protein journal · 2026Article
- Residual disease activity in cystic fibrosis lung disease: implications for clinical management and research.American journal of respiratory and critical care medicine · 2026Review
- Feasibility and Impact of a Coached Home-Based Exercise Program on Cardiorespiratory Fitness in Adults With Cystic Fibrosis on Highly Effective Modulator Therapy.CHEST pulmonary · 2026Article
- De-escalation of Medications After Initiation of Elexacaftor-Tezacaftor-Ivacaftor in Children 6 to 11 Years of Age With Cystic Fibrosis.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2026Article
- Medication discontinuation in the era of elexacaftor/tezacaftor/ivacaftor: an Australian survey and qualitative interview.Internal medicine journal · 2026Article
- Meaningful Criteria to Persons Living With Cystic Fibrosis and Their Healthcare Providers in Helping Determine Adjustments to Routine Clinical Follow-Up.Pediatric pulmonology · 2026Article
- Programmed Cell Death in Chronic Rhinosinusitis.Clinical and translational allergy · 2026Review
- The Impact of Personal-Level Social Networks on Treatment Adherence, Depression, Anxiety, and Perceived Stigma Among Adults with Cystic Fibrosis: An Egocentric Network Analysis.International journal of behavioral medicine · 2026Article
- Remodelling of cystic fibrosis respiratory microbiota in response to extended elexacaftor-tezacaftor-ivacaftor therapy.Microbiome · 2026Article
- Elexacaftor/tezacaftor/ivacaftor is associated with long-term reduction in use of chronic respiratory therapies in cystic fibrosis.Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society · 2026Observational
- Distinct CFTR Mutation Spectrum and Atypical Clinical Presentations in Chinese Patients with Cystic Fibrosis.International journal of molecular sciences · 2026Review
- A pilot study of ultra-low-dose chest CT combined with co-production in cystic fibrosis care.Pediatric research · 2026Article
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Authors and funding
23 authors at 19 institutions in 2 countries.
Funding
Abstract
backgroundReducing treatment burden is a priority for people with cystic fibrosis, whose health has benefited from using new modulators that substantially increase CFTR protein function. The SIMPLIFY study aimed to assess the effects of discontinuing nebulised hypertonic saline or dornase alfa in individuals using the CFTR modulator elexacaftor plus tezacaftor plus ivacaftor (ETI).
methodsThe SIMPLIFY study included two parallel, multicentre, open-label, randomised, controlled, non-inferiority trials at 80 participating clinics across the USA in the Cystic Fibrosis Therapeutics Development Network. We included individuals with cystic fibrosis aged 12-17 years with percent predicted FEV
findingsFrom Aug 25, 2020, to May 25, 2022, a total of 672 unique participants were screened for eligibility for one or both trials, resulting in 847 total random assignments across both trials with 594 unique participants. 370 participants were randomly assigned in the hypertonic saline trial and 477 in the dornase alfa trial. Participants across both trials had an average ppFEV
interpretationIn individuals with cystic fibrosis on ETI with relatively well preserved pulmonary function, discontinuing daily hypertonic saline or dornase alfa for 6 weeks did not result in clinically meaningful differences in pulmonary function when compared with continuing treatment.
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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.