Evidence map›Paper›PMID 33061349›Full record

Trial reportInternational journal of chronic obstructive pulmonary disease2020

Clinically Important Deterioration Among Patients with Chronic Obstructive Pulmonary Disease (COPD) Treated with Nebulized Glycopyrrolate: A Post Hoc Analysis of Pooled Data from Two Randomized, Double-Blind, Placebo-Controlled Studies.

Edward M Kerwin, Lindsey Murray, Xiaoli Niu, Carole Dembek

2 registry-linked trialsOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in International journal of chronic obstructive pulmonary disease, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 5 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 2 pooled it
0.6field-weighted citation impact, top 26% 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.

NCT02347761 phase3completednot on this map

Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Efficacy and Safety Trial of 12 Weeks of Treatment With Nebulized SUN-101 in Patients With COPD: GOLDEN-3 (Glycopyrrolate for Obstructive Lung Disease Via Electronic Nebulizer)

TypeinterventionalSponsorSunovion Respiratory Development Inc.Ran2015 to 2015Enrolled653ConditionsCOPDArmsSUN-101 50 mcg BID eFlow (CS) nebulizer, SUN-101 25 mcg BID eFlow (CS) nebulizer, Placebo BID eFlow Closed System (CS) nebulizer
NCT02347774 phase3completednot on this map

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Efficacy and Safety Trial of 12 Weeks of Treatment With Nebulized SUN-101 in Patients With COPD: GOLDEN-4 (Glycopyrrolate for Obstructive Lung Disease Via Electronic Nebulizer

TypeinterventionalSponsorSunovion Respiratory Development Inc.Ran2015 to 2015Enrolled641ConditionsCOPD, Chronic Obstructive Pulmonary DiseaseArmsSUN-101 50 mcg BID eFlow (CS) nebulizer, SUN-101 25 mcg BID eFlow (CS) nebulizer, Placebo eFlow (CS) nebulizer
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 2 syntheses or guidelines pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Article
  5. 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

4 authors at 3 institutions in 1 country.

Edward M KerwinClinical Research Institute of Southern Oregon, Medford, OR, USA.ORCID 0000-0002-1697-9036
Lindsey MurrayEvidera, Bethesda, MD, USA.
Xiaoli NiuSunovion Pharmaceuticals Inc., Marlborough, MA, USA.
Carole DembekSunovion Pharmaceuticals Inc., Marlborough, MA, USA.
Sunovion (United States) · USClinical Research Institute · USIthaka Harbors · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: Using a composite endpoint, pooled data from two 12-week Phase III placebo-controlled trials (GOLDEN 3, NCT02347761; GOLDEN 4, NCT02347774) were analyzed to determine whether glycopyrrolate inhalation solution (25 mcg and 50 mcg) administered twice daily (BID) via the eFlow Methods: CID was defined as ≥100-mL decrease from baseline in post-bronchodilator trough forced expiratory volume in one second (FEV Results: Compared to placebo, GLY 25 mcg and 50 mcg BID over 12 weeks significantly reduced the risk of CID by 50% (OR: 0.50 [0.37-0.68]) and 40% (OR: 0.60 [0.44-0.80]), respectively. Subjects treated with GLY 25 mcg BID were 59% less likely to experience CID in FEV Conclusion: Nebulized GLY over 12 weeks significantly reduced the risk of CID and provided greater short-term stability in patients with moderate-to-very-severe COPD.

Indexed as

Bronchodilator AgentsGlycopyrrolatePulmonary Disease, Chronic ObstructiveAdministration, InhalationAgedDisease ProgressionDouble-Blind MethodFemaleForced Expiratory VolumeHumansMuscarinic AntagonistsSeverity of Illness IndexTreatment OutcomeBronchodilator AgentsGlycopyrrolateMuscarinic Antagonistsclinically important deteriorationcomposite measurenebulized glycopyrrolate

Identifiers

PMID33061349
PMCPMC7535937
OpenAlexW3090131282

What OpenQuestion 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 OpenQuestion graph.