Evidence map›Paper›PMID 32450869›Full record

ArticleRespiratory research2020

Benefits of glycopyrrolate/formoterol fumarate metered dose inhaler (GFF MDI) in improving lung function and reducing exacerbations in patients with moderate-to-very severe COPD: a pooled analysis of the PINNACLE studies.

Fernando J Martinez, Brian J Lipworth, Klaus F Rabe, David J Collier, Gary T Ferguson, Sanjay Sethi, Gregory J Feldman, Gerald O'Brien, Martin Jenkins, Colin Reisner

3 registry-linked trialsOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Respiratory research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are 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
0.5field-weighted citation impact, top 31% 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.

NCT01854645 phase3completednot on this map

A Randomized, Double Blind, Chronic Dosing, Placebo-Controlled, Parallel Group, Multi Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD, Compared With Placebo and Spiriva® Handihaler® (Tiotropium Bromide 18 µg Open-Label) as an Active Control

TypeinterventionalSponsorPearl Therapeutics, Inc.Ran2013 to 2015Enrolled2,103ConditionsChronic Obstructive Pulmonary DiseaseArmsGFF MDI, GP MDI, FF MDI, Open-label tiotropium bromide inhalation powder (Spiriva® Handihaler®), Placebo MDI
NCT01854658 phase3completednot on this map

A Randomized, Double-Blind (Test Products and Placebo), Chronic Dosing (24 Weeks), Placebo-Controlled, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD, Compared With Placebo

TypeinterventionalSponsorPearl Therapeutics, Inc.Ran2013 to 2015Enrolled1,615ConditionsChronic Obstructive Pulmonary Disease (COPD)ArmsGFF MDI (PT003), GP MDI (PT001), FF MDI (PT005), Placebo
NCT02343458 phase3completednot on this map

A Randomized, Double-Blind, Chronic Dosing (24 Weeks), Placebo-Controlled, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD, Compared With Placebo

TypeinterventionalSponsorPearl Therapeutics, Inc.Ran2015 to 2017Enrolled1,756ConditionsChronic Obstructive Pulmonary DiseaseArmsGFF MDI (PT003), FF MDI (PT005), GP MDI (PT001), Placebo MDI
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Review
  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

10 authors at 7 institutions in 3 countries.

Fernando J MartinezWeill Cornell Medical College, New York-Presbyterian Hospital/Weill Cornell Medical Center, 525 E 68th St, Room M-522, Box 130, New York, NY, 10065, USA. fjm2003@med.cornell.edu.
Brian J LipworthScottish Centre for Respiratory Research, Ninewells Hospital, University of Dundee, Dundee, Scotland, UK.
Klaus F RabeLungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, Member of the German Center for Lung Research (DZL), Kiel, Germany.
David J CollierWilliam Harvey Research Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
Gary T FergusonPulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, USA.
Sanjay SethiUniversity at Buffalo, SUNY, Buffalo, NY, USA.
Gregory J FeldmanS. Carolina Pharmaceutical Research, Spartanburg, SC, USA.
Gerald O'Brienformerly of AstraZeneca, Wilmington, DE, USA.
Martin JenkinsAstraZeneca, Cambridge, UK.
Colin ReisnerAstraZeneca, Morristown, NJ, USA.
AstraZeneca (United States) · USAstraZeneca (United Kingdom) · GBLungenClinic Grosshansdorf · DENew York Hospital Queens · USQueen Mary University of London · GBUniversity at Buffalo, State University of New York · USUniversity of Dundee · GB

Funding

AstraZeneca NA
6 · The paper itself

Abstract

backgroundThe Phase III PINNACLE studies assessed the efficacy and safety of glycopyrrolate/formoterol fumarate metered dose inhaler (GFF MDI), a dual long-acting bronchodilator for chronic obstructive pulmonary disease (COPD). Here we present a pre-specified pooled analysis of PINNACLE-1, PINNACLE-2, and PINNACLE-4.

methodsPINNACLE-1, -2, and -4 were multicenter, double-blind, randomized controlled trials that enrolled patients with moderate-to-very severe COPD, with no requirement for exacerbation history or a high symptom burden. Patients received GFF MDI 18/9.6 μg, glycopyrrolate (GP) MDI 18 μg, formoterol fumarate (FF) MDI 9.6 μg, or placebo MDI, twice-daily for 24 weeks. The primary endpoint of the pooled analysis was the change from baseline in morning pre-dose trough forced expiratory volume in 1 s (FEV

resultsThe pooled intent-to-treat population included 4983 patients; of these, 61.9% had a COPD assessment test (CAT) score ≥15, and 25.0% had experienced ≥1 moderate/severe exacerbation in the past year. At week 24, GFF MDI improved morning pre-dose trough FEV

conclusionsThis pooled analysis of the PINNACLE studies demonstrated that GFF MDI improved lung function and reduced the risk of exacerbations compared with monocomponents and placebo in patients with COPD. Exacerbation reductions with GFF MDI versus comparators were generally greater in patients with higher symptom burden and those with exacerbation history.

trial registrationClinicalTrials.gov NCT01854645, NCT01854658, and NCT02343458. Registered 13 May 2013 (NCT01854645, NCT01854658) and 6 January 2015 (NCT02343458).

Indexed as

Severity of Illness IndexAdministration, InhalationAdultAgedAged, 80 and overBronchodilator AgentsClinical Trials, Phase III as TopicDouble-Blind MethodDrug Therapy, CombinationFemaleFormoterol FumarateGlycopyrrolateHumansLungMaleMetered Dose InhalersBronchodilator AgentsFormoterol FumarateGlycopyrrolateChronic obstructive pulmonary diseaseClinically important deteriorationExacerbationsFixed-dose combinationFormoterol fumarate dihydrateGFF MDIGlycopyrroniumLAMA/LABAMetered dose inhalerSymptomatic

Identifiers

PMID32450869
PMCPMC7249639
OpenAlexW3028897368

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.