Trial reportAmerican journal of respiratory and critical care medicine2013
Lung clearance index as an outcome measure for clinical trials in young children with cystic fibrosis. A pilot study using inhaled hypertonic saline.
Trial report in American journal of respiratory and critical care medicine, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 46 papers, 3 of them syntheses that pooled it.
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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
46 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Nebulised hypertonic saline for cystic fibrosis.The Cochrane database of systematic reviews · 2023Pooled it
- Timing of hypertonic saline inhalation for cystic fibrosis.The Cochrane database of systematic reviews · 2020Pooled it
- Nebulised hypertonic saline for cystic fibrosis.The Cochrane database of systematic reviews · 2018Pooled it
- Infant lung function tests as endpoints in the ISIS multicenter clinical trial in cystic fibrosis.Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society · 2016Trial
- Long-term cardiopulmonary function in children treated for empyema: comparison of chest drain with fibrinolytics and video-assisted thoracoscopic surgery.BMJ open respiratory research · 2026Article
- ENHANCE: a community partnership charting the evolution of early-life cystic fibrosis disease manifestations in a new era of management.ERJ open research · 2026Article
- Antenatal Maternal Smoking and Lung Function in Very Prematurely Born Children.Pediatric pulmonology · 2026Article
- How Does the Corrected Exhalyzer Software Change the Predictive Value of LCI in Pulmonary Exacerbations in Children with Cystic Fibrosis?Diagnostics (Basel, Switzerland) · 2023Article
- Efficacy of hypertonic saline versus isotonic saline among children with cystic fibrosis: A systematic review and meta-analysis.Canadian journal of respiratory therapy : CJRT = Revue canadienne de la therapie respiratoire : RCTR · 2023Review
- Comment on "Efficacy of hypertonic saline versus isotonic saline among children with cystic fibrosis: A systematic review and meta-analysis".Canadian journal of respiratory therapy : CJRT = Revue canadienne de la therapie respiratoire : RCTR · 2023Article
- [Update on cystic fibrosis : From neonatal screening to causal treatment].Radiologie (Heidelberg, Germany) · 2022Article
- A screening tool to identify risk for bronchiectasis progression in children with cystic fibrosis.Pediatric pulmonology · 2022Article
- TRACK-CF prospective cohort study: Understanding early cystic fibrosis lung disease.Frontiers in medicine · 2022Article
- Quantification of Phenotypic Variability of Lung Disease in Children with Cystic Fibrosis.Genes · 2021Review
- Sensitive structural and functional measurements and 1-year pulmonary outcomes in pediatric cystic fibrosis.Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society · 2021Article
- Toward the Establishment of New Clinical Endpoints for Cystic Fibrosis: The Role of Lung Clearance Index and Cardiopulmonary Exercise Testing.Frontiers in pediatrics · 2021Review
- Article
- Designing Clinical Trials for Anti-Inflammatory Therapies in Cystic Fibrosis.Frontiers in pharmacology · 2020Review
- The future of cystic fibrosis care: a global perspective.The Lancet. Respiratory medicine · 2020Review
- A two-center analysis of hyperpolarizedJournal of cystic fibrosis : official journal of the European Cystic Fibrosis Society · 2019Article
Corrections and comments
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Authors and funding
9 authors.
Funding
Abstract
rationaleLung clearance index (LCI), measured by multiple breath washout (MBW), is a noninvasive measure of ventilation inhomogeneity that holds promise as an objective physiologic endpoint for clinical trials in infants and preschool children with cystic fibrosis (CF).
objectivesTo study the feasibility of using LCI to assess treatment effect outcomes in CF trials of infants and preschoolers.
methodsThe Infant Study of Inhaled Saline trial was a multicenter, randomized, controlled trial of hypertonic (7%) versus isotonic (0.9%) saline inhaled twice daily for 48 weeks in children with CF under 6 years of age. LCI measurements were performed in a single-center pilot substudy at baseline and 48 weeks using a respiratory mass spectrometer and sulfur hexafluoride as the tracer gas. LCI measurements were standardized using published normative data (zLCI) to account for height-related changes in LCI during early childhood. A generalized estimating equation model with an interaction between treatment group and test occasion was used to estimate a treatment effect. MEASUREMENTS AND MAIN
resultsA total of 27 participants were randomized; 25 participants, aged (median [range]) 2.6 (0.34-4.95) years, had acceptable baseline and follow-up LCI measures. On average, LCI decreased in the hypertonic saline group (n = 12) by 1.19 z-scores units (95% confidence interval [CI] = -2.46 to 0.06), and remained stable in the isotonic saline group (n = 13) at 0.81 (95% CI = -0.40 to 2.02). A significant treatment effect was observed for zLCI (2.01; 95% CI = 0.26 to 3.76; P = 0.025).
conclusionsMBW testing is feasible in an interventional study in infants and preschool children with CF. These pilot findings support the development of MBW and LCI as an objective outcome measure in interventional trials in young children with CF, and provide estimates for sample size calculations for future studies.
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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.