Evidence map›Paper›PMID 26952309›Full record

Trial reportInternational journal of chronic obstructive pulmonary disease2016

Early response to inhaled bronchodilators and corticosteroids as a predictor of 12-month treatment responder status and COPD exacerbations.

Peter M Calverley, Dirkje S Postma, Antonio R Anzueto, Barry J Make, Göran Eriksson, Stefan Peterson, Christine R Jenkins

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International journal of chronic obstructive pulmonary disease, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
2.3field-weighted citation impact, top 12% 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

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Early Clinically Important Improvement (ECII) and Exacerbation Outcomes in COPD Patients.International journal of chronic obstructive pulmonary disease · 2020
    Trial
  4. Trial
  5. Trial
  6. Article
  7. Inhaled corticosteroids for chronic obstructive pulmonary disease: what is their role in therapy?International journal of chronic obstructive pulmonary disease · 2018
    Review
  8. Article
  9. 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

7 authors at 6 institutions in 5 countries.

Peter M CalverleyPulmonary and Rehabilitation Research Group, University Hospital Aintree, Liverpool, UK.
Dirkje S PostmaDepartment of Pulmonary Medicine and Tuberculosis, Gronigen Research Institute for Asthma and COPD, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
Antonio R AnzuetoDivision of Pulmonary Diseases and Critical Care Medicine, University of Texas Health Sciences Center, School of Medicine, University of Texas, San Antonio, TX, USA; South Texas Veterans Health Care System, San Antonio, TX, USA.
Barry J MakeDivision of Pulmonary Sciences and Critical Care Medicine, National Jewish Health, University of Colorado, Denver, CO, USA.
Göran ErikssonDepartment of Respiratory Medicine and Allergology, University Hospital, Lund, Sweden.
Stefan PetersonStatMind AB, Lund, Sweden.
Christine R JenkinsGeorge Institute for Global Health, Concord Clincal School, The University of Sydney, Sydney, NSW, Australia.
Aintree University Hospital · GBLund University · SENational Jewish Health · USRepublican Scientific and Practical Centre of Pulmonology and Tuberculosis · BYSouth Texas Veterans Health Care System · USThe George Institute for Global Health · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEarly treatment response markers, for example, improvement in forced expiratory volume in 1 second (FEV1) and St George's Respiratory Questionnaire (SGRQ) total score, may help clinicians to better manage patients with chronic obstructive pulmonary disease (COPD). We investigated the prevalence of clinically important improvements in FEV1 and SGRQ scores after 2-month budesonide/formoterol or formoterol treatment and whether such improvements predict subsequent improvements and exacerbation rates.

methodsThis post hoc analysis is based on data from three double-blind, randomized studies in patients with moderate-to-very-severe COPD receiving twice-daily budesonide/formoterol or formoterol alone for 6 or 12 months. Prebronchodilator FEV1 and SGRQ total score were measured before treatment and at 2 and 12 months; COPD exacerbation rates were measured during months 2-12. Responders were defined by ≥100 mL improvement in prebronchodilator FEV1 and ≥4-point decrease in SGRQ total score.

resultsOverall, 2,331 and 1,799 patients were included in the 0-2- and 0-12-month responder analyses, respectively, and 2,360 patients in the 2-12-month exacerbation rate analysis. At 2 months, 35.1% of patients were FEV1 responders and 44.3% were SGRQ responders. The probability of response was significantly greater with budesonide/formoterol than with formoterol or placebo for both parameters. Two-month responders had a greater chance of 12-month response than 2-month nonresponders for both FEV1 (odds ratio, 5.57; 95% confidence interval, 4.14-7.50) and SGRQ (odds ratio, 3.87; 95% confidence interval, 2.83-5.31). Two-month response in FEV1 (P<0.001), but not SGRQ (P=0.11), was associated with greater reductions in exacerbation risk.

conclusionEarly FEV1 and SGRQ treatment responses relate to their changes at 12 months. FEV1 response, but not SGRQ response, at 2 months predicts the risk of a future COPD exacerbation in some, but not all patients. This is potentially useful in clinical practice, although more sensitive and specific markers of favorable treatment response are required.

Indexed as

Pulmonary Disease, Chronic ObstructiveAdministration, InhalationAdrenal Cortex HormonesAdultAgedBronchodilator AgentsBudesonideDouble-Blind MethodDrug Therapy, CombinationFemaleForced Expiratory VolumeFormoterol FumarateHumansMaleMiddle AgedPrognosisAdrenal Cortex HormonesBronchodilator AgentsBudesonideFormoterol Fumarateanti-inflammatoriesbronchodilator effectchronic obstructive pulmonary diseasepredictorsrisk assessmentrisk factors

Identifiers

PMID26952309
PMCPMC4772946
OpenAlexW2274013777

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.