Evidence map›Paper›PMID 30962681›Full record

Trial reportInternational journal of chronic obstructive pulmonary disease2019

AMPLIFY: a randomized, Phase III study evaluating the efficacy and safety of aclidinium/formoterol vs monocomponents and tiotropium in patients with moderate-to-very severe symptomatic COPD.

Sanjay Sethi, Edward Kerwin, Henrik Watz, Gary T Ferguson, Robert M Mroz, Rosa Segarra, Eduard Molins, Diana Jarreta, Esther Garcia Gil

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIComparative StudyEquivalence Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International journal of chronic obstructive pulmonary disease, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02796677 (A 24 Week Treatment, Multicenter, Randomized, Double Blinded, Double Dummy, Parallel-group, Clinical Trial Evaluating the Efficacy and Safety of Aclidinium Bromide 400 μg/Formoterol Fumarate 12 μg Fixed-dose Combination BID Compared With Each Monotherapy), which is not on this map. Cited by 13 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 3 pooled it
3.7field-weighted citation impact, top 6% 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.

NCT02796677 phase3completednot on this map

A 24 Week Treatment, Multicenter, Randomized, Double Blinded, Double Dummy, Parallel-group, Clinical Trial Evaluating the Efficacy and Safety of Aclidinium Bromide 400 μg/Formoterol Fumarate 12 μg Fixed-dose Combination BID Compared With Each Monotherapy (Aclidinium Bromide 400 μg BID and Formoterol Fumarate 12 μg BID) and Tiotropium 18 μg QD When Administered to Patients With Stable Chronic Obstructive Pulmonary Disease.

TypeinterventionalSponsorAstraZenecaRan2016 to 2017Enrolled1,595ConditionsChronic Obstructive Pulmonary DiseaseArmsAclidinium bromide 400 μg/Formoterol Fumarate 12 μg (AB/FF 400/12 μg), Aclidinium bromide 400 μg (AB 400 μg), Formoterol fumarate 12 μg (FF 12 μg), Placebo to AB/FF 400/12 μg, AB 400 μg and FF 12 μg, Tiotropium 18 μg (TIO 18 μg)
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 3 syntheses or guidelines pooled it, 27 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Observational
  7. Real-Life Effectiveness of Aclidinium/Formoterol on COPD Control: The REDACT Observational Study.International journal of chronic obstructive pulmonary disease · 2026
    Observational
  8. New Perspectives on Chronic Obstructive Pulmonary Disease.International journal of chronic obstructive pulmonary disease · 2022
    Article
  9. Article
  10. Article
  11. Observational
  12. Formoterol for the Treatment of Chronic Obstructive Pulmonary Disease.International journal of chronic obstructive pulmonary disease · 2020
    Review
  13. 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

9 authors at 5 institutions in 4 countries.

Sanjay SethiJacobs School of Medicine and Biomedical Sciences, University at Buffalo, SUNY, Buffalo, NY, USA, ssethi@buffalo.edu.
Edward KerwinClinical Research Institute, Medford, OR, USA.
Henrik WatzPulmonary Research Institute at LungenClinic Grosshansdorf, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany.
Gary T FergusonPulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, USA.
Robert M MrozCentrum Medycyny Oddechowej, Białystok, Poland.
Rosa SegarraAstraZeneca, Barcelona, Spain.
Eduard MolinsAstraZeneca, Barcelona, Spain.
Diana JarretaAstraZeneca, Barcelona, Spain.
Esther Garcia GilAstraZeneca, Barcelona, Spain.
AstraZeneca (Spain) · ESClinical Research Institute · USGerman Center for Lung Research · DEJacobs (United States) · USMedical University of Białystok · PL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: AMPLIFY assessed the efficacy and safety of aclidinium bromide/formoterol fumarate (AB/FF) vs its monocomponents and tiotropium (TIO) in patients with moderate-to-very severe symptomatic COPD (NCT02796677). Methods: In this 24-week, Phase III, double-dummy, active-controlled study, symptomatic patients (COPD Assessment Test score ≥10) were randomized to twice-daily AB/FF 400/12 µg, AB 400 µg, or FF 12 µg, or once-daily TIO 18 µg. Co-primary endpoints were change from baseline at week 24 in 1-hour morning post-dose FEV Results: A total of 1,594 patients were randomized; 566 entered the sub-study. At week 24, 1-hour post-dose FEV Conclusion: In patients with moderate-to-very severe symptomatic COPD, twice-daily AB/FF significantly improved lung function vs monocomponents and TIO, and early morning symptom control vs TIO.

Indexed as

Adrenergic beta-2 Receptor AgonistsAgedBronchodilator AgentsDouble-Blind MethodDrug CombinationsEuropeFemaleForced Expiratory VolumeFormoterol FumarateHumansIsraelLungMaleMiddle AgedMuscarinic AntagonistsPulmonary Disease, Chronic Obstructiveaclidinium bromideAdrenergic beta-2 Receptor AgonistsBronchodilator AgentsDrug CombinationsFormoterol FumarateMuscarinic AntagonistsTiotropium BromideTropanes24-hour lung functionaclidinium bromidebronchodilatorsLABALAMA

Identifiers

PMID30962681
PMCPMC6435124
OpenAlexW2923446750

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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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.