Evidence map›Paper›PMID 32106777›Full record

ArticleTherapeutic advances in respiratory disease

Efficacy and safety of revefenacin for nebulization in patients with chronic obstructive pulmonary disease taking concomitant ICS/LABA or LABA: subgroup analysis from phase III trials.

Sanjay Sethi, James F Donohue, Gary T Ferguson, Chris N Barnes, Glenn D Crater

3 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Therapeutic advances in respiratory disease. 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 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.4field-weighted citation impact, top 36% 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.

NCT02459080 phase3completednot on this map

A Phase 3, 12-week, Randomized, Double-blind Placebo-controlled Parallel Group Study of Nebulized TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease

TypeinterventionalSponsorMylan Inc.Ran2015 to 2016Enrolled619ConditionsChronic Obstructive Pulmonary Disease (COPD)ArmsTD-4208, Placebo
NCT02512510 phase3completednot on this map

A Phase 3, 12-week, Randomized, Double-blind Placebo-controlled Parallel Group Study of Nebulized TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease

TypeinterventionalSponsorMylan Inc.Ran2015 to 2016Enrolled611ConditionsChronic Obstructive Pulmonary Disease (COPD)ArmsTD-4208, Placebo
NCT02518139 phase3completednot on this map

A Phase 3, 52-week, Randomized, Active-Controlled Parallel Group Study to Evaluate the Safety and Tolerability of Nebulized TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease

TypeinterventionalSponsorMylan Inc.Ran2015 to 2017Enrolled1,060ConditionsChronic Obstructive Pulmonary Disease (COPD)ArmsTD-4208, Tiotropium
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 3 citations in OpenAlex.

  1. Article
  2. Revefenacin, a once-daily, long-acting muscarinic antagonist, for nebulized maintenance therapy in patients with chronic obstructive pulmonary disease.American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists · 2021
    Review
  3. 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

5 authors at 3 institutions in 1 country.

Sanjay SethiUniversity at Buffalo, State University of New York, Buffalo, NY, USA.
James F DonohueUniversity of North Carolina School of Medicine, Chapel Hill, NC, USA.
Gary T FergusonPulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, USA.
Chris N BarnesTheravance Biopharma US, Inc., South San Francisco, CA, USA.
Glenn D CraterTheravance Biopharma US, Inc., South San Francisco, CA 94080, USA.ORCID 0000-0002-1159-1323
Theravance Biopharma (United States) · USUniversity at Buffalo, State University of New York · USUniversity of North Carolina at Chapel Hill · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCombinations of a long-acting muscarinic receptor antagonist (LAMA), long-acting β-agonist (LABA), and inhaled corticosteroid (ICS) are used for patients with persistent chronic obstructive pulmonary disease (COPD) exacerbations on bronchodilator monotherapy. In this prespecified subgroup analysis, we assessed the efficacy and safety of the LAMA revefenacin in patients with COPD taking concomitant LABA, including ICS/LABA (LABA subgroup).

methodsEfficacy data were obtained from two 12-week, replicate, placebo-controlled trials and safety data were pooled from the 12-week and a 52-week tiotropium-controlled trial. Patients received revefenacin 175 µg or placebo in the 12-week or tiotropium 18 µg in the 52-week studies. The efficacy endpoint was least squares (LS) mean change from baseline in trough forced expiratory volume in 1 second (FEV

resultsRevefenacin produced similar improvements from baseline in trough FEV

conclusionsOnce daily revefenacin for nebulization can be an effective and well-tolerated treatment for patients who require concomitant use of LABA with or without ICS. CLINICALTRIALS.GOV IDENTIFIERS: NCT02512510, NCT02459080, NCT02518139

Indexed as

Administration, InhalationAdrenal Cortex HormonesAdrenergic beta-AgonistsAgedBenzamidesBronchodilator AgentsCarbamatesClinical Trials, Phase III as TopicDrug Administration ScheduleDrug Therapy, CombinationFemaleForced Expiratory VolumeHumansLungMaleMiddle AgedAdrenal Cortex HormonesAdrenergic beta-AgonistsBenzamidesBronchodilator AgentsCarbamatesMuscarinic Antagonistsrevefenacinlong-acting muscarinic receptor antagonistnebulizationtriple therapy

Identifiers

PMID32106777
PMCPMC7052452
OpenAlexW3008177675

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.