Evidence map›Paper›PMID 32532226›Full record

Trial reportBMC pulmonary medicine2020

An 8 week open-label interventional multicenter study to explore the lung clearance index as endpoint for clinical trials in cystic fibrosis patients ≥8 years of age, chronically infected with Pseudomonas aeruginosa.

Sivagurunathan Sutharsan, Susanne Naehrig, Uwe Mellies, Christian Sieder, Jörg Ziegler

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IVMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC pulmonary medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02248922 (An 8 Week Open-label Interventional Multicenter Study to Evaluate the Lung Clearance Index as Endpoint for Clinical Trials in Cystic Fibrosis Patients ≥ 6 Years of Age, Chronically Infected With Pseudomonas Aeruginosa), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.1field-weighted citation impact, top 49% 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.

NCT02248922 phase4terminatednot on this map

An 8 Week Open-label Interventional Multicenter Study to Evaluate the Lung Clearance Index as Endpoint for Clinical Trials in Cystic Fibrosis Patients ≥ 6 Years of Age, Chronically Infected With Pseudomonas Aeruginosa

TypeinterventionalSponsorNovartis PharmaceuticalsRan2015 to 2017Enrolled17ConditionsChronic Lung Infection With Pseudomonas Aeruginosa in Cystic FibrosisArmsTIS or TIP
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. Review
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

5 authors at 4 institutions in 1 country.

Sivagurunathan SutharsanDivision for Cystic Fibrosis, Department of Pulmonary Medicine, University Medicine Essen - Ruhrlandklinik, Essen, Germany. sivagurunathan.sutharsan@rlk.uk-essen.de.ORCID http://orcid.org/0000-0003-4069-4900
Susanne NaehrigCystic Fibrosis Center for Adults, University Hospital Munich, Med. Klinik V, Munich, Germany.
Uwe MelliesPediatric Pulmonology and Sleep Medicine, Children's Hospital, University of Duisburg-Essen, Essen, Germany.
Christian SiederNovartis Pharma GmbH, Nürnberg, Germany.
Jörg ZieglerNovartis Pharma GmbH, Nürnberg, Germany.
Novartis (Germany) · DEMünchen Klinik · DERuhrlandklinik · DEUniversity of Duisburg-Essen · DE

Funding

Novartis Pharma NA
6 · The paper itself

Abstract

backgroundForced expiratory volume in 1 second (FEV

methodsThis open-label, single-arm study enrolled CF patients with Pseudomonas aeruginosa infection, who were treated with tobramycin (28-day on/off regime). FEV

resultsAll patients (n = 17) showed elevated LCI of > 11 despite 3 patients having normal FEV

conclusionsDue to the low evaluable sample size, no specific trend was observed related to the changes between LCI, FEV

trial registrationThe study is registered with ClinicalTrials.gov, identifier: NCT02248922.

Indexed as

Administration, InhalationAdolescentAdultAnti-Bacterial AgentsChildCystic FibrosisFemaleForced Expiratory VolumeHumansMalePilot ProjectsPseudomonas aeruginosaPseudomonas InfectionsRespiratory Tract InfectionsTobramycinYoung AdultAnti-Bacterial AgentsTobramycinAntibioticsClinical trialsCystic fibrosisForced expiratory volume in 1 secondLung clearance indexPseudomonas aeruginosaTobramycin

Identifiers

PMID32532226
PMCPMC7291662
OpenAlexW3035280634

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.