Evidence map›Paper›PMID 25466700›Full record

Trial reportJournal of cystic fibrosis : official journal of the European Cystic Fibrosis Society2015

Pharmacokinetics and tolerability of oral sildenafil in adults with cystic fibrosis lung disease.

J L Taylor-Cousar, C Wiley, L A Felton, C St Clair, M Jones, D Curran-Everett, K Poch, D P Nichols, G M Solomon, M T Saavedra and 2 more

3 registry-linked trialsOpen access · greenAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
3.1field-weighted citation impact, top 8% 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.

NCT01132482 phase2completednot on this map

Phase II Study of the Effects of Sildenafil on CFTR-dependent Ion Transport Activity

TypeinterventionalSponsorNational Jewish HealthRan2015 to 2017Enrolled19ConditionsCystic FibrosisArmsSildenafil, Placebo
NCT02626182 phase1 / phase2completednot on this map

Evaluation and Treatment of Pulmonary Vascular Disease in Moderate to Severe Cystic Fibrosis Lung Disease

TypeinterventionalSponsorNational Jewish HealthRan2015 to 2018Enrolled14ConditionsCystic FibrosisArmssildenafil, placebo
NCT04039087 phase2 / phase3completednot on this mapstarted 2019, after this paper: background citation

Mechanisms of Exercise Intolerance in Cystic Fibrosis: Role of PDE5 Inhibition

TypeinterventionalSponsorNational Jewish HealthRan2019 to 2024Enrolled31ConditionsCystic FibrosisArmsSildenafil 40mg oral capsule, Placebo Oral capsule
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it, 38 citations in OpenAlex.

  1. Pooled it
  2. Sildenafil improves vascular endothelial function in patients with cystic fibrosis.American journal of physiology. Heart and circulatory physiology · 2018
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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

12 authors at 5 institutions in 1 country.

J L Taylor-CousarDepartment of Medicine, National Jewish Health, 1400 Jackson Street, Denver, CO 80206, United States; Department of Pediatrics, National Jewish Health, 1400 Jackson Street, Denver, CO 80206, United States. Electronic address: Taylor-CousarJ@NJHealth.org.
C WileyDepartment of Pharmaceutical Sciences, College of Pharmacy, University of New Mexico, Albuquerque, NM, United States.
L A FeltonDepartment of Pharmaceutical Sciences, College of Pharmacy, University of New Mexico, Albuquerque, NM, United States.
C St ClairDepartment of Medicine, National Jewish Health, 1400 Jackson Street, Denver, CO 80206, United States.
M JonesDepartment of Medicine, National Jewish Health, 1400 Jackson Street, Denver, CO 80206, United States.
D Curran-EverettDivision of Biostatistics and Bioinformatics, National Jewish Health, 1400 Jackson Street, Denver, CO 80206, United States; Department of Biostatistics and Informatics, Colorado School of Public Health, University of Colorado Denver, Denver, CO 80262, United States.
K PochDepartment of Medicine, National Jewish Health, 1400 Jackson Street, Denver, CO 80206, United States.
D P NicholsDepartment of Medicine, National Jewish Health, 1400 Jackson Street, Denver, CO 80206, United States; Department of Pediatrics, National Jewish Health, 1400 Jackson Street, Denver, CO 80206, United States.
G M SolomonInternal Medicine, University of Alabama, 1720 2nd Ave South, Birmingham, AL 35294, United States.
M T SaavedraDepartment of Medicine, National Jewish Health, 1400 Jackson Street, Denver, CO 80206, United States.
F J AccursoDepartment of Pediatrics, University of Colorado School of Medicine, Children's Hospital Colorado, 13123 E 16th Ave, Aurora, CO 80045, United States.
J A NickDepartment of Medicine, National Jewish Health, 1400 Jackson Street, Denver, CO 80206, United States.
National Jewish Health · USUniversity of New Mexico · USChildren's Hospital Colorado · USColorado School of Public Health · USUniversity of Alabama · US

Funding

CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR025780 · NCRR · UNIVERSITY OF COLORADO DENVER · PI SOKOL, RONALD J. · 2008 to 2011
$61.3M
Colorado Clinical and Translational Sciences InstituteUL1TR001082 · NCATS · UNIVERSITY OF COLORADO DENVER · PI SOKOL, RONALD J. · 2013 to 2017
$48.0M
Use of Phosphodiesterase Inhibitors to Evaluate the Pathobiology of CFK23HL103801 · NHLBI · NATIONAL JEWISH HEALTH · PI TAYLOR COUSAR, JENNIFER LYNN · 2011 to 2015
$722k
NCATS NIH HHS UL1 TR001082NCRR NIH HHS UL1 RR025780NHLBI NIH HHS 1K23HL103801-01A1NHLBI NIH HHS K23 HL103801
6 · The paper itself

Abstract

rationaleAirway inflammation is central to cystic fibrosis (CF) pathophysiology. Pre-clinical models have shown that phosphodiesterase inhibitors (PDEi) like sildenafil have anti-inflammatory activity. PDEi have not been studied in CF subjects.

objectivesWe evaluated the pharmacokinetics, tolerability, and safety of sildenafil in subjects with CF. Sputum biomarkers were used to explore efficacy.

methodsAn open-label pilot study of oral sildenafil administration was conducted in adults with mild to moderate CF lung disease. Subjects received oral sildenafil 20 or 40 mg p.o. t.i.d. for 6 weeks. MEASUREMENTS AND MAIN

resultsTwenty subjects completed the study. Estimated elimination rate constants were statistically different in subjects with CF compared to previously published non-CF subjects. Side effects were generally mild. There were no drug-related serious adverse events. Sputum neutrophil elastase activity decreased.

conclusionsSubjects with CF may eliminate sildenafil at a faster rate than non-CF subjects. Sildenafil administration was safe in subjects with CF and decreased sputum elastase activity. Sildenafil warrants further study as an anti-inflammatory in CF.

Indexed as

Cystic FibrosisSildenafil CitrateAdultBiomarkersDrug MonitoringFemaleHumansInflammationLeukocyte ElastaseLungMalePhosphodiesterase 5 InhibitorsSeverity of Illness IndexSputumTreatment OutcomeBiomarkersLeukocyte ElastasePhosphodiesterase 5 InhibitorsSildenafil CitrateBiomarkersCystic fibrosisInflammationPharmacokineticsPhosphodiesterase inhibitorsSildenafil

Identifiers

PMID25466700
PMCPMC4355330
OpenAlexW2156002868

What OpenQuestion holds

Textmetadata
LicenceTDM
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.