Evidence map›Paper›PMID 31266489›Full record

Trial reportRespiratory research2019

Effect of smoking status on lung function, patient-reported outcomes, and safety among COPD patients treated with glycopyrrolate inhalation powder: pooled analysis of GEM1 and GEM2 studies.

Donald P Tashkin, Thomas Goodin, Alyssa Bowling, Barry Price, Ayca Ozol-Godfrey, Sanjay Sharma, Shahin Sanjar

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Respiratory research, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.4field-weighted citation impact, top 17% 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

8 citing papers in PubMed, 11 citations in OpenAlex.

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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 3 institutions in 1 country.

Donald P TashkinDavid Geffen School of Medicine, University of California at Los Angeles, Los Angeles, CA, USA. dtashkin@mednet.ucla.edu.
Thomas GoodinSunovion Pharmaceuticals Inc., Marlborough, MA, USA.
Alyssa BowlingSunovion Pharmaceuticals Inc., Marlborough, MA, USA.
Barry PriceSunovion Pharmaceuticals Inc., Marlborough, MA, USA.
Ayca Ozol-GodfreySunovion Pharmaceuticals Inc., Marlborough, MA, USA.
Sanjay SharmaSunovion Pharmaceuticals Inc., Marlborough, MA, USA.
Shahin SanjarSunovion Pharmaceuticals Inc., Marlborough, MA, USA.
Sunovion (United States) · USVion Pharmaceuticals (United States) · USUniversity of California, Los Angeles · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSmoking is a major risk factor for COPD and may impact the efficacy of COPD treatments; however, a large proportion of COPD patients continue to smoke following diagnosis.

methodsThis post-hoc analysis of pooled data from the replicate 12-week, placebo-controlled GEM1 and GEM2 studies assessed the impact of smoking status on the efficacy and safety of glycopyrrolate 15.6 μg twice daily vs placebo in patients with moderate-to-severe COPD. Data from 867 patients enrolled in GEM1 and GEM2 were pooled for analysis and grouped by smoking status (57% current smokers, 43% ex-smokers). Forced expiratory volume in 1 s (FEV

resultsTreatment with glycopyrrolate resulted in significant improvements in all lung function measures, independent of smoking status. In both current and ex-smokers, changes from baseline in trough FEV

conclusionsIn this post-hoc analysis of GEM1 and GEM2, glycopyrrolate use led to significant improvements in lung function, independent of baseline smoking status; improvements were less marked among patients receiving background ICS, regardless of baseline smoking status. Improvements in PROs were greater with glycopyrrolate than placebo, and the magnitude of changes was numerically greater among current smokers. The safety profile of glycopyrrolate was comparable between current smokers and ex-smokers.

Indexed as

Patient Reported Outcome MeasuresAdministration, InhalationAgedBronchodilator AgentsDouble-Blind MethodFemaleGlycopyrrolateHumansLungMaleMiddle AgedTobacco SmokingTreatment OutcomeVital CapacityBronchodilator AgentsGlycopyrrolateBronchodilatorCOPDGlycopyrrolateLAMALung functionPatient-reported outcomesSafetySmoking status

Identifiers

PMID31266489
PMCPMC6604131
OpenAlexW2955889261

What OpenQuestion holds

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LicenceCC BY
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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.