Evidence map›Paper›PMID 30290801›Full record

Trial reportRespiratory research2018

Concomitant inhaled corticosteroid use and the risk of pneumonia in COPD: a matched-subgroup post hoc analysis of the UPLIFT® trial.

Donald P Tashkin, Marc Miravitlles, Bartolomé R Celli, Norbert Metzdorf, Achim Mueller, David M G Halpin, Antonio Anzueto

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Respiratory research, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00144339 (A Randomized, Double-blind, Placebo-controlled, Parallel Group Trial Assessing the Rate of Decline of Lung Function With Tiotropium 18 mcg Inhalation Capsule Once Daily in Patients With Chronic Obstructive Pulmonary Disease), which is 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
2.4field-weighted citation impact, top 11% 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.

NCT00144339 phase3completednot on this map

A Randomized, Double-blind, Placebo-controlled, Parallel Group Trial Assessing the Rate of Decline of Lung Function With Tiotropium 18 mcg Inhalation Capsule Once Daily in Patients With Chronic Obstructive Pulmonary Disease (COPD).

TypeinterventionalSponsorBoehringer IngelheimRan2002Enrolled5,993ConditionsPulmonary Disease, Chronic ObstructiveArmstiotropium, placebo
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it, 24 citations in OpenAlex.

  1. Systematic review on long-term adverse effects of inhaled corticosteroids in the treatment of COPD.European respiratory review : an official journal of the European Respiratory Society · 2021
    Pooled it
  2. Trial
  3. Article
  4. Review
  5. How inhaled corticosteroids target inflammation in COPD.European respiratory review : an official journal of the European Respiratory Society · 2023
    Review
  6. Review
  7. Article
  8. Article
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  11. Article
  12. Review
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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

7 authors at 6 institutions in 4 countries.

Donald P TashkinDepartment of Medicine, David Geffen School of Medicine, University of California Los Angeles, 10833 Le Conte Avenue, Los Angeles, CA, 90095-1690, USA. dtashkin@mednet.ucla.edu.
Marc MiravitllesPneumology Department, Hospital Universitari Vall d'Hebron, CIBER de Enfermedades Respiratorias (CIBERES), Barcelona, Spain.
Bartolomé R CelliBrigham and Women's Hospital, Boston, MA, USA.
Norbert MetzdorfTA Respiratory/Biosimilars, Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.
Achim MuellerBiostatistics and Data Sciences Europe, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany.
David M G HalpinRoyal Devon and Exeter Hospital, Exeter, UK.
Antonio AnzuetoPulmonary/Critical Care, University of Texas, and South Texas Veterans Health Care System, San Antonio, TX, USA.
Boehringer Ingelheim (Germany) · DEBrigham and Women's Hospital · USCentro de Investigación Biomédica en Red de Enfermedades Respiratorias · ESRoyal Devon and Exeter Hospital · GBSouth Texas Veterans Health Care System · USUniversity of California, Los Angeles · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundUse of inhaled corticosteroids (ICS) increases the risk of pneumonia in chronic obstructive pulmonary disease (COPD), but the magnitude of risk with different ICS remains unclear.

methodsA post hoc analysis of the 4-year UPLIFT® trial to assess whether pneumonia risk differed by type of ICS (fluticasone propionate [FP], other ICS, or no ICS) in permanent users (defined by use until end of study) or in users at baseline (sensitivity analysis).

resultsFor the permanent-users analysis, 825 patients receiving FP throughout the trial, 825 patients receiving other ICS and 825 patients not receiving ICS were matched on relevant baseline features 1:1:1. A significantly greater risk of pneumonia was observed for FP versus no ICS: the hazard ratio (HR) for risk of pneumonia was 1.33 (95% confidence interval [CI] 1.00, 1.75; p = 0.046) and the rate ratio (RR) was 1.58 (95% CI 1.05, 2.37; p = 0.028). A greater risk was also found for FP versus other ICS: HR 1.28 (95% CI 0.97, 1.68; p = 0.078) and RR 1.48 (95% CI 1.00, 2.19; p = 0.049). A higher proportion of patients on FP were hospitalized with pneumonia (7.9%) versus other ICS (6.7%) or no ICS (5.9%). Whilst other ICS use was associated with the highest number of fatal pneumonia events, the total number of fatal pneumonia incidents was low. A similar pattern was observed in the sensitivity analyses, which included 4002 patients on different treatments at baseline (FP, other ICS, and no ICS) and considered potential switches during the study.

conclusionThe results support existing evidence of an increased pneumonia risk with FP use compared with other ICS and no ICS use in patients with COPD. Healthcare professionals should evaluate the risk-benefit ratio of using ICS when making treatment decisions with their patients.

trial registrationPost hoc analysis of UPLIFT®. ClinicalTrials.gov number: NCT00144339 . Retrospectively registered September 2, 2005.

Indexed as

Administration, InhalationAdrenal Cortex HormonesAgedBronchodilator AgentsDouble-Blind MethodFemaleFluticasoneHumansMaleMiddle AgedPneumoniaPulmonary Disease, Chronic ObstructiveResearch DesignRisk FactorsTiotropium BromideAdrenal Cortex HormonesBronchodilator AgentsFluticasoneTiotropium BromideCOPDFluticasone propionateInhaled corticosteroidsPneumoniaUPLIFT®

Identifiers

PMID30290801
PMCPMC6173940
OpenAlexW2894895332

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.