Evidence map›Paper›PMID 31666076›Full record

Trial reportRespiratory research2019

Maintained therapeutic effect of revefenacin over 52 weeks in moderate to very severe Chronic Obstructive Pulmonary Disease (COPD).

James F Donohue, Edward Kerwin, Sanjay Sethi, Brett Haumann, Srikanth Pendyala, Lorna Dean, Chris N Barnes, Edmund J Moran, Glenn Crater

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIRandomized 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. It is linked to trial NCT02518139 (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), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
2.8field-weighted citation impact, top 9% 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.

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

8 citing papers in PubMed, 19 citations in OpenAlex.

  1. Revefenacin Area Under the Curve Spirometry in Patients with Moderate to Very Severe COPD.International journal of chronic obstructive pulmonary disease · 2024
    Trial
  2. Trial
  3. Article
  4. 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
  5. Review
  6. Article
  7. Review
  8. Nebulized Therapies in COPD: Past, Present, and the Future.International journal of chronic obstructive pulmonary disease · 2020
    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

9 authors at 4 institutions in 1 country.

James F DonohuePulmonary Medicine, UNC School of Medicine, Chapel Hill, NC, USA.
Edward KerwinClinical Research Institute of Southern Oregon, PC, Medford, OR, USA.
Sanjay SethiUniversity at Buffalo, State University of New York, Buffalo, NY, USA.
Brett HaumannTheravance Biopharma US, Inc., 901 Gateway Boulevard, South San Francisco, CA, 94080, USA.
Srikanth PendyalaTheravance Biopharma US, Inc., 901 Gateway Boulevard, South San Francisco, CA, 94080, USA.
Lorna DeanTheravance Biopharma US, Inc., 901 Gateway Boulevard, South San Francisco, CA, 94080, USA.
Chris N BarnesTheravance Biopharma US, Inc., 901 Gateway Boulevard, South San Francisco, CA, 94080, USA.
Edmund J MoranTheravance Biopharma US, Inc., 901 Gateway Boulevard, South San Francisco, CA, 94080, USA.
Glenn CraterTheravance Biopharma US, Inc., 901 Gateway Boulevard, South San Francisco, CA, 94080, USA. gcrater@theravance.com.ORCID http://orcid.org/0000-0002-1159-1323
Theravance Biopharma (United States) · USClinical Research Institute · USUniversity at Buffalo, State University of New York · USUniversity of North Carolina Health Care · US

Funding

Theravance Biopharma, Ireland Limited Inc. (IE) Not applicable
6 · The paper itself

Abstract

backgroundRevefenacin is a long-acting muscarinic antagonist that was recently approved for the nebulized treatment of chronic obstructive pulmonary disease (COPD). Although shorter duration studies have documented the efficacy of revefenacin in COPD, longer-term efficacy has not been described. In a recent 52-week safety trial, revefenacin was well tolerated and had a favorable benefit-risk profile. Here we report exploratory efficacy and health outcomes in patients receiving revefenacin 175 μg or 88 μg daily during the 52-week trial.

methodsIn this randomized, parallel-group, 52-week trial (NCT02518139), 1055 participants with moderate to very severe COPD received revefenacin 175 μg or 88 μg in a double-blind manner, or open-label active control tiotropium.

resultsOver the 52-week treatment period, both doses of revefenacin, as well as tiotropium, elicited significant (all p < 0.0003) improvements from baseline in trough forced expiratory volume in 1 s (FEV

conclusionsSignificant sustained improvements from baseline in trough FEV

trial registrationNCT02518139 ; Registered 5 August 2015.

Indexed as

Severity of Illness IndexAgedBenzamidesBronchodilator AgentsCarbamatesDouble-Blind MethodDrug Administration ScheduleFemaleForced Expiratory VolumeHumansMaleMiddle AgedMuscarinic AntagonistsPulmonary Disease, Chronic ObstructiveTreatment OutcomeBenzamidesBronchodilator AgentsCarbamatesMuscarinic Antagonistsrevefenacin

Identifiers

PMID31666076
PMCPMC6822411
OpenAlexW2982651237

What OpenQuestion holds

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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.