Trial reportJournal of cystic fibrosis : official journal of the European Cystic Fibrosis Society2016
Infant lung function tests as endpoints in the ISIS multicenter clinical trial in cystic fibrosis.
Trial report in Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 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
8 citing papers in PubMed, 3 syntheses or guidelines pooled it, 14 citations in OpenAlex.
- 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
- Forced expiratory flows and diffusion capacity in infants born from mothers with pre-eclampsia.Pediatric pulmonology · 2022Article
- TRACK-CF prospective cohort study: Understanding early cystic fibrosis lung disease.Frontiers in medicine · 2022Article
- Hyperinflation is associated with increased respiratory rate and is a more sensitive measure of cystic fibrosis lung disease during infancy compared to forced expiratory measures.Pediatric pulmonology · 2021Article
- Cystic fibrosis respiratory microbiota: unraveling complexity to inform clinical practice.Expert review of respiratory medicine · 2018Review
- Timing of hypertonic saline inhalation for cystic fibrosis.The Cochrane database of systematic reviews · 2016Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 8 institutions in 2 countries.
Funding
Abstract
backgroundThe Infant Study of Inhaled Saline (ISIS) in CF was the first multicenter clinical trial to utilize infant pulmonary function tests (iPFTs) as an endpoint.
methodsSecondary analysis of ISIS data was conducted in order to assess feasibility of iPFT measures and their associations with respiratory symptoms. Standard deviations were calculated to aid in power calculations for future clinical trials.
resultsSeventy-three participants enrolled, 70 returned for the final visit; 62 (89%) and 45 (64%) had acceptable paired functional residual capacity (FRC) and raised volume measurements, respectively. Mean baseline FEV0.5, FEF75 and FRC z-scores were 0.3 (SD: 1.2), -0.2 (SD: 2.0), and 1.8 (SD: 2.0).
conclusionsiPFTs are not appropriate primary endpoints for multicenter clinical trials due to challenges of obtaining acceptable data and near-normal average raised volume measurements. Raised volume measures have potential to serve as secondary endpoints in future clinical CF trials.
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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.