Evidence map›Paper›PMID 38446336›Full record

ArticlePulmonary therapy2024

Association between Increased Risk of Pneumonia with ICS in COPD: A Continuous Variable Analysis of Patient Factors from the IMPACT Study.

Bhumika Aggarwal, Paul Jones, Alejandro Casas, Mauro Gomes, Siwasak Juthong, Diego Litewka, Bernice Ong-Dela Cruz, Alejandra Ramirez-Venegas, Abdullah Sayiner, James van Hasselt and 4 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Pulmonary therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02164513 (A Phase III, 52 Week, Randomized, Double-blind, 3-arm Parallel Group Study, Comparing the Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination FF/UMEC/VI With the Fixed Dose Dual Combinations of FF/VI and UMEC/VI, All Administered Once-daily in the Morning Via a Dry Powder Inhaler in Subjects With Chronic Obstructive Pulmonary Disease), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
2.5field-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.

NCT02164513 phase3completednot on this map

A Phase III, 52 Week, Randomized, Double-blind, 3-arm Parallel Group Study, Comparing the Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination FF/UMEC/VI With the Fixed Dose Dual Combinations of FF/VI and UMEC/VI, All Administered Once-daily in the Morning Via a Dry Powder Inhaler in Subjects With Chronic Obstructive Pulmonary Disease

TypeinterventionalSponsorGlaxoSmithKlineRan2014 to 2017Enrolled10,355ConditionsPulmonary Disease, Chronic ObstructiveArmsfluticasone furoate (FF), vilanterol (VI), umeclidinium bromide (UMEC)
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Paradigm Shift in the Treatment of Chronic Obstructive Pulmonary Disease Improves Patient Outcomes.International journal of chronic obstructive pulmonary disease · 2025
    Article
  5. Article
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

14 authors at 8 institutions in 8 countries.

Bhumika AggarwalEmerging Markets, GSK, 23 Rochester Park, Singapore, 139234, Singapore. bhumika.x.aggarwal@gsk.com.ORCID http://orcid.org/0000-0002-8370-9319
Paul JonesGlobal Medical, Regulatory and Quality, GlaxoSmithKline Plc., Brentford, UK.
Alejandro CasasAIREPOC (Integrated Care and Rehabilitation Program of COPD), Pulmonary Colombian Foundation, and El Rosario University, Bogotá, Colombia.
Mauro GomesDepartment of Pneumology at Santa Casa Medical School, São Paulo, Brazil.
Siwasak JuthongDivision of Respiratory and Respiratory Critical Care Medicine, Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand.
Diego LitewkaUnidad Neumonologia, Hospital Juan A. Fernandez, Buenos Aires, Argentina.
Bernice Ong-Dela CruzDivision of Pulmonary and Critical Care Medicine, Philippine Heart Center, Quezon, Philippines.
Alejandra Ramirez-VenegasDepartment of Research in Tobacco and COPD, Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas, Mexico City, Mexico.
Abdullah SayinerDepartment of Chest Diseases, Ege University Faculty of Medicine, Izmir, Turkey.
James van HasseltGSK, Regional Medical Affairs, Bryanston, Gauteng, South Africa.
Chris ComptonGSK, Brentford, UK.
Lee TombsPrecise Approach Ltd, London, UK.
Stephen WengGSK, Brentford, UK.
Gur LevyEmerging Markets, GSK, Panama City, Panama.
AMS (Singapore) · SGEge University · TRGlaxoSmithKline (United Kingdom) · GBHospital Fernández · ARHospital Samaritano de São Paulo · BRInstituto Nacional de Enfermedades Respiratorias · MXPhilippine Heart Center · PHPrince of Songkla University · TH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionDespite the proven benefits of inhaled corticosteroid (ICS)-containing triple therapy for chronic obstructive pulmonary disease (COPD), clinicians limit patient exposure to ICS due to the risk of pneumonia. However, there are multiple factors associated with the risk of pneumonia in patients with COPD. This post hoc analysis of IMPACT trial data aims to set the risks associated with ICS into a context of specific patient-related factors that contribute to the risk of pneumonia.

methodsThe 52-week, double-blind IMPACT trial randomized patients with symptomatic COPD and ≥1 exacerbation in the prior year 2:2:1 to once-daily fluticasone furoate (FF)/umeclidinium (UMEC)/vilanterol (VI), FF/VI or UMEC/VI. Annual rate of on-treatment pneumonias in the intent-to-treat population associated with age, body mass index (BMI), percent predicted forced expiratory volume in 1 s (FEV

resultsThis analysis revealed that the annual rate of pneumonia showed the lowest risk at the age of 50 years. The 95% confidence intervals (CI) between ICS-containing and non-ICS containing treatments diverged in ages > 63 years, suggesting a significantly increased ICS-related risk in older patients. In contrast, the annual rate of pneumonia rose in both groups below BMI of 22.5 kg/m

conclusionsThere was little evidence of a differential effect of older age, lower BMI, lower FEV CLINICAL

trial registrationIMPACT ClinicalTrials.gov number, NCT02164513.

Indexed as

COPDICSIMPACTPneumonia riskPost hoc analysis

Identifiers

PMID38446336
PMCPMC11282004
OpenAlexW4392505132

What Socratic holds

Textmetadata
LicenceCC BY-NC
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 Socratic graph.