Evidence map›Paper›PMID 29096627›Full record

Trial reportRespiratory research2017

A 28-day, randomized, double-blind, placebo-controlled, parallel group study of nebulized revefenacin in patients with chronic obstructive pulmonary disease.

Krishna K Pudi, Chris N Barnes, Edmund J Moran, Brett Haumann, Edward Kerwin

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Respiratory research, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02040792 (A Phase 2B, 28-Day, Randomized, Double-Blind Placebo-Controlled Parallel Group Study of Nebulized TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease), which is not on this map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed
–field-weighted citation impact
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.

NCT02040792 phase2completednot on this map

A Phase 2B, 28-Day, Randomized, Double-Blind Placebo-Controlled Parallel Group Study of Nebulized TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease

TypeinterventionalSponsorMylan Inc.Ran2014 to 2014Enrolled355ConditionsCOPDArmsTD-4208, Placebo
3 · Its place in the literature

Who cites it

20 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Soft drugs: design principles and topical applications.Nature reviews. Drug discovery · 2026
    Review
  4. Review
  5. Muscarinic control of cardiovascular function in humans: a review of current clinical evidence.Clinical autonomic research : official journal of the Clinical Autonomic Research Society · 2024
    Review
  6. 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
  7. Article
  8. Review
  9. Review
  10. Future Trends in Nebulized Therapies for Pulmonary Disease.Journal of personalized medicine · 2020
    Review
  11. Review
  12. Review
  13. Review
  14. Review
  15. Article
  16. Revefenacin: A Once-Daily, Long-Acting Bronchodilator For Nebulized Treatment Of COPD.International journal of chronic obstructive pulmonary disease · 2019
    Review
  17. Pharmacokinetics and safety of revefenacin in subjects with impaired renal or hepatic function.International journal of chronic obstructive pulmonary disease · 2019
    Article
  18. Review
  19. Article
  20. 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

5 authors.

Krishna K PudiUpstate Pharmaceutical Research, Greenville, SC, USA.
Chris N BarnesTheravance Biopharma US, Inc., South San Francisco, CA, USA.
Edmund J MoranTheravance Biopharma US, Inc., South San Francisco, CA, USA.
Brett HaumannTheravance Biopharma UK Limited, London, UK. bhaumann@theravance.com.
Edward KerwinClinical Research Institute of Southern Oregon, PC, Medford, OR, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRevefenacin is a once-daily long-acting muscarinic antagonist (LAMA) in clinical development for the treatment of patients with chronic obstructive pulmonary disease (COPD). In a dose-ranging study, nebulized once-daily revefenacin had a long duration of action in patients after 7 days' administration of doses up to 700 μg. In this multiple-dose study, the bronchodilation efficacy and adverse events profile were characterized in patients administered nebulized revefenacin once daily for 28 days.

methodsA total of 355 COPD patients (mean age 62 years, mean forced expiratory volume in 1 s [FEV

resultsRevefenacin (88, 175 and 350 μg) significantly improved D28 trough FEV

conclusionsThese data suggest that 88 and 175 μg revefenacin are appropriate doses for use in longer-term safety and efficacy trials. Revefenacin offers the potential for the first once-daily LAMA for nebulization in patients with COPD who require or prefer a nebulized drug delivery option.

trial registrationClinicalTrials.gov NCT02040792 . Registered January 16, 2014.

Indexed as

Nebulizers and VaporizersAdministration, InhalationAdultAgedDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansMaleMaximal Expiratory Flow RateMiddle AgedMuscarinic AntagonistsPulmonary Disease, Chronic ObstructiveTime FactorsMuscarinic Antagonists

Identifiers

PMID29096627
PMCPMC5667509

What OpenQuestion holds

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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.