Evidence map›Paper›PMID 21163939›Full record

Trial reportCancer prevention research (Philadelphia, Pa.)2011

Randomized phase II trial of inhaled budesonide versus placebo in high-risk individuals with CT screen-detected lung nodules.

Giulia Veronesi, Eva Szabo, Andrea Decensi, Aliana Guerrieri-Gonzaga, Massimo Bellomi, Davide Radice, Stefania Ferretti, Giuseppe Pelosi, Matteo Lazzeroni, Davide Serrano and 6 more

Open access · bronzeAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Cancer prevention research (Philadelphia, Pa.), 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 1 pooled it
3.6field-weighted citation impact, top 7% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 1 synthesis or guideline pooled it, 67 citations in OpenAlex.

  1. Guideline
  2. Trial
  3. Inhaled corticosteroid normalizes some but not all airway vascular remodeling in COPD.International journal of chronic obstructive pulmonary disease · 2016
    Trial
  4. Trial
  5. Lung cancer chemoprevention with celecoxib in former smokers.Cancer prevention research (Philadelphia, Pa.) · 2011
    Trial
  6. Review
  7. Article
  8. Review
  9. Review
  10. Article
  11. Review
  12. Article
  13. Review
  14. Article
  15. Article
  16. Review
  17. Long-term effects of inhaled budesonide on screening-detected lung nodules.Annals of oncology : official journal of the European Society for Medical Oncology · 2015
    Article
  18. Article
  19. Review
  20. 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

16 authors at 5 institutions in 2 countries.

Giulia VeronesiDivision of Thoracic Surgery, European Institute of Oncology, Via Ripamonti 435, I-20141 Milan, Italy. giulia.veronesi@ieo.it
Eva Szabo
Andrea Decensi
Aliana Guerrieri-Gonzaga
Massimo Bellomi
Davide Radice
Stefania Ferretti
Giuseppe Pelosi
Matteo Lazzeroni
Davide Serrano
Scott M Lippman
Lorenzo Spaggiari
Angela Nardi-Pantoli
Sergio Harari
Clara Varricchio
Bernardo Bonanni
European Institute of Oncology · ITThe University of Texas MD Anderson Cancer Center · USEnte Ospedaliero Ospedali Galliera · ITUniversity of Milan · ITOspedale San Giuseppe · IT

Funding

PHASE I and II CLINICAL TRIALS OF CHEMOPREVENTIVE AGENTS-261035159-261035159N01CN035159 · CN · UNIVERSITY OF TEXAS M D ANDER · PI LIPPMAN, SCOTT M. · 2004 to 2006
–
NCI NIH HHS N01 CN035159NCI NIH HHS N01-CN-35159
6 · The paper itself

Abstract

Screening CT identifies small peripheral lung nodules, some of which may be pre- or early invasive neoplasia. Secondary end point analysis of a previous chemoprevention trial in individuals with bronchial dysplasia showed reduction in size of peripheral nodules by inhaled budesonide. We performed a randomized, double-blind, placebo-controlled phase IIb trial of inhaled budesonide in current and former smokers with CT-detected lung nodules that were persistent for at least 1 year. A total of 202 individuals received inhaled budesonide, 800 μg twice daily or placebo for 1 year. The primary endpoint was the effect of treatment on target nodule size in a per person analysis after 1 year. The per person analysis showed no significant difference between the budesonide and placebo arms (response rate 2% and 1%, respectively). Although the per lesion analysis revealed a significant effect of budesonide on regression of existing target nodules (P = 0.02), the appearance of new lesions was similar in both groups and thus the significance was lost in the analysis of all lesions. The evaluation by nodule type revealed a nonsignificant trend toward regression of nonsolid and partially solid lesions after budesonide treatment. Budesonide was well tolerated, with no unexpected side effects identified. Treatment with inhaled budesonide for 1 year did not significantly affect peripheral lung nodule size. There was a trend toward regression of nonsolid and partially solid nodules after budesonide treatment. Because a subset of these nodules is more likely to represent precursors of adenocarcinoma, additional follow-up is needed.

Indexed as

Administration, InhalationAgedAnti-Inflammatory AgentsBudesonideDouble-Blind MethodEndpoint DeterminationFemaleHumansLung NeoplasmsMaleMiddle AgedMultiple Pulmonary NodulesPlacebosPrognosisResearch DesignRespiratory Function TestsAnti-Inflammatory AgentsBudesonidePlacebos

Identifiers

PMID21163939
PMCPMC3017323
OpenAlexW2158746677

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.