Evidence map›Paper›PMID 30310273›Full record

Trial reportInternational journal of chronic obstructive pulmonary disease

Improved lung function and patient-reported outcomes with co-suspension delivery technology glycopyrrolate/formoterol fumarate metered dose inhaler in COPD: a randomized Phase III study conducted in Asia, Europe, and the USA.

Brian J Lipworth, David J Collier, Yasuhiro Gon, Nanshan Zhong, Koichi Nishi, Rongchang Chen, Samir Arora, Andrea Maes, Shahid Siddiqui, Colin Reisner and 1 more

Open access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International journal of chronic obstructive pulmonary disease. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 9 pooled it
4.6field-weighted citation impact, top 5% 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

25 citing papers in PubMed, 9 syntheses or guidelines pooled it, 41 citations in OpenAlex.

  1. Pooled it
  2. Race-Based Pulmonary Function Testing Correction in COPD Inhaler Therapy Trials: A Systematic Review.International journal of chronic obstructive pulmonary disease · 2024
    Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Efficacy and cardiovascular safety of LAMA in patients with COPD: a systematic review and meta-analysis.Journal of investigative medicine : the official publication of the American Federation for Clinical Research · 2021
    Pooled it
  7. Pooled it
  8. Pooled it
  9. Pooled it
  10. Trial
  11. Trial
  12. Trial
  13. Trial
  14. Trial
  15. Article
  16. Article
  17. Observational
  18. Article
  19. Formoterol for the Treatment of Chronic Obstructive Pulmonary Disease.International journal of chronic obstructive pulmonary disease · 2020
    Review
  20. Review
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

11 authors at 7 institutions in 5 countries.

Brian J LipworthScottish Centre for Respiratory Research, Ninewells Hospital, University of Dundee, Dundee, Scotland, UK, b.j.lipworth@dundee.ac.uk.
David J CollierWilliam Harvey Research Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
Yasuhiro GonItabashi Hospital, Nihon University School of Medicine, Itabashi, Tokyo, Japan.
Nanshan ZhongGuangzhou Institute of Respiratory Health, State Key Laboratory of Respiratory Diseases, National Clinical Research Center of Respiratory Diseases, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, People's Republic of China.
Koichi NishiIshikawa Prefectural Central Hospital, Kanazawa, Ishikawa, Japan.
Rongchang ChenGuangzhou Institute of Respiratory Health, State Key Laboratory of Respiratory Diseases, National Clinical Research Center of Respiratory Diseases, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, People's Republic of China.
Samir AroraAventiv Research Inc., Columbus, OH, USA.
Andrea MaesPearl - a member of the AstraZeneca group, Morristown, NJ, USA.
Shahid SiddiquiAstraZeneca, Gaithersburg, MD, USA.
Colin ReisnerPearl - a member of the AstraZeneca group, Morristown, NJ, USA.
Ubaldo J MartinAstraZeneca, Gaithersburg, MD, USA.
AstraZeneca (Poland) · PLAstraZeneca (United States) · USFirst Affiliated Hospital of Guangzhou Medical University · CNIshikawa Prefectural Central Hospital · JPNihon University Itabashi Hospital · JPNinewells Hospital · GBQueen Mary University of London · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCOPD is a major global cause of mortality and morbidity. PINNACLE-4 evaluated the efficacy and safety of GFF MDI (glycopyrrolate/formoterol fumarate metered dose inhaler) in patients from Asia, Europe, and the USA with moderate-to-very severe COPD.

methodsIn this double-blind, placebo-controlled, Phase III study, patients were randomized to treatment with GFF MDI 18/9.6 μg, glycopyrrolate (GP) MDI 18 μg, formoterol fumarate (FF) MDI 9.6 μg, or placebo MDI (all twice daily) for 24 weeks. Lung function, patient-reported outcomes (symptoms and health-related quality of life), and safety were assessed.

resultsOf the 1,756 patients randomized, 1,740 patients were included in the intent-to-treat population (mean age 64.2 years, 74.1% male, and 40.2% Asian). GFF MDI significantly improved morning predose trough FEV

conclusionThese results demonstrated the efficacy of GFF MDI in patients with moderate-to-very severe COPD. GFF MDI was well tolerated, with a safety profile commensurate with long-acting bronchodilators.

Indexed as

Metered Dose InhalersPatient Reported Outcome MeasuresAdministration, InhalationAdultAgedAged, 80 and overAsiaBronchodilator AgentsDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleDrug Therapy, CombinationEuropeFemaleFollow-Up StudiesForced Expiratory VolumeBronchodilator AgentsFormoterol FumarateGlycopyrrolatebronchodilatorCOPDco-suspension delivery technologymuscarinic antagonistβ2-agonist

Identifiers

PMID30310273
PMCPMC6167125
OpenAlexW2892705619

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.