Evidence map›Paper›PMID 26451734›Full record

Trial reportCOPD2016

Efficacy and Safety of Umeclidinium Added to Fluticasone Propionate/Salmeterol in Patients with COPD: Results of Two Randomized, Double-Blind Studies.

Thomas M Siler, Edward Kerwin, Karen Singletary, Jean Brooks, Alison Church

3 registry-linked trialsOpen access · greenAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in COPD, 2016. 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 21 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 4 pooled it
9.6field-weighted citation impact, top 1% 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.

NCT03084718 phase2completednot on this mapstarted 2017, after this paper: background citation

An 8-week, Multicenter, Randomized, Double-blind, Placebo and Active-controlled, Parallel Group, Dose-ranging Study to Evaluate the Efficacy and Safety of 3 Doses of CHF 718 pMDI (HFA Beclomethasone Dipropionate Via Pressured Metered Dose Inhaler) in Asthmatic Subjects.

TypeinterventionalSponsorChiesi Farmaceutici S.p.A.Ran2017 to 2018Enrolled610ConditionsAsthmaArmsCHF 718 pMDI, Placebo pMDI, Beclomethasone Dipropionate (BDP)
NCT03084796 phase2completednot on this mapstarted 2017, after this paper: background citation

A 6-week, Multicenter, Randomized, Double-blind, Placebo and Active-controlled, Parallel Group, Dose-ranging Study to Evaluate the Efficacy and Safety of 4 Doses of CHF 5259 pMDI (HFA Glycopyrronium Bromide Via Pressurized Metered Dose Inhaler) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

TypeinterventionalSponsorChiesi Farmaceutici S.p.A.Ran2017 to 2018Enrolled733ConditionsCOPD, Chronic Obstructive Pulmonary DiseaseArmsCHF 5259, Placebo, Tiotropium Bromide 18 µg Inhalation Capsule
NCT03086460 phase2completednot on this mapstarted 2017, after this paper: background citation

A Randomized, Double-blind, Placebo and Active-controlled, Incomplete Block Cross-over, Dose Ranging Study to Evaluate the Efficacy and Safety of 4 Doses of CHF 1531 pMDI (Formoterol Fumarate) in Asthmatic Subjects

TypeinterventionalSponsorChiesi Farmaceutici S.p.A.Ran2017 to 2018Enrolled67ConditionsAsthmaArmsCHF 1531 pMDI, Formoterol Inhalation Solution, Placebo pMDI
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 4 syntheses or guidelines pooled it, 64 citations in OpenAlex.

  1. Pooled it
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  4. The efficacy ofTherapeutic advances in respiratory disease
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  13. Real-World Experience of Treating Chronic Obstructive Pulmonary Disease with Triple Therapy.International journal of chronic obstructive pulmonary disease · 2023
    Article
  14. Article
  15. Article
  16. Article
  17. Clinical burden of illness among patients with severe eosinophilic COPD.International journal of chronic obstructive pulmonary disease · 2019
    Article
  18. Article
  19. Triple therapy (ICS/LABA/LAMA) in COPD: time for a reappraisal.International journal of chronic obstructive pulmonary disease · 2018
    Review
  20. Observational
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.

Thomas M Silera Midwest Chest Consultants, PC, St. Charles , Missouri , USA.
Edward Kerwinb Clinical Research Institute of Southern Oregon , Medford , Oregon , USA.
Karen Singletaryc GSK, Respiratory and Immuno-Inflammation, Research Triangle Park , North Carolina , USA.
Jean Brooksd GSK, Respiratory Medicines Development Centre, Stockley Park , Uxbridge , United Kingdom.
Alison Churchc GSK, Respiratory and Immuno-Inflammation, Research Triangle Park , North Carolina , USA.
Research Triangle Park Foundation · USAmerican College of Chest Physicians · USClinical Research Institute · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Combinations of drugs with distinct and complementary mechanisms of action may offer improved efficacy in the treatment of chronic obstructive pulmonary disease (COPD). In two 12-week, double-blind, parallel-group studies, patients with COPD were randomized 1:1:1 to once-daily umeclidinium (UMEC; 62.5 μg and 125 μg) or placebo (PBO), added to twice-daily fluticasone propionate/salmeterol (FP/SAL; 250/50 μg). In both studies, the primary efficacy measure was trough forced expiratory volume in 1 second (FEV1) at Day 85. Secondary endpoints were weighted-mean (WM) FEV1 over 0-6 hours post-dose (Day 84) and rescue albuterol use. Health-related quality of life outcomes (St. George's Respiratory Questionnaire [SGRQ] and COPD assessment test [CAT]) were also examined. Safety was assessed throughout. Both UMEC+FP/SAL doses provided statistically significant improvements in trough FEV1 (Day 85: 0.127-0.148 L) versus PBO+FP/SAL. Similarly, both UMEC+FP/SAL doses provided statistically-significant improvements in 0-6 hours post-dose WM FEV1 versus PBO+FP/SAL (Day 84: 0.144-0.165 L). Rescue use over Weeks 1-12 decreased with UMEC+FP/SAL in both studies versus PBO+FP/SAL (Study 1, 0.3 puffs/day [both doses]; Study 2, 0.5 puffs/day [UMEC 125+FP/SAL]). Decreases from baseline in CAT score were generally larger for both doses of UMEC+FP/SAL versus PBO+FP/SAL (except for Day 84 Study 2). In Study 1, no differences in SGRQ score were observed between UMEC+FP/SAL and PBO+FP/SAL; however, in Study 2, statistically significant improvements were observed with UMEC 62.5+FP/SAL (Day 28) and UMEC 125+FP/SAL (Days 28 and 84) versus PBO+FP/SAL. The incidence of on-treatment adverse events across all treatment groups was 37-41% in Study 1 and 36-38% in Study 2. Overall, these data indicate that the combination of UMEC+FP/SAL can provide additional benefits over FP/SAL alone in patients with COPD.

Indexed as

Administration, InhalationAgedAlbuterolBronchodilator AgentsDouble-Blind MethodDrug Therapy, CombinationFemaleFluticasone-Salmeterol Drug CombinationForced Expiratory VolumeGlucocorticoidsHumansMaleMiddle AgedMuscarinic AntagonistsPulmonary Disease, Chronic ObstructiveQuinuclidinesAlbuterolBronchodilator AgentsFluticasone-Salmeterol Drug CombinationGlucocorticoidsGSK573719Muscarinic AntagonistsQuinuclidinesbronchodilationinhaled corticosteroidlong-acting beta agonistlong-acting muscarinic antagonist

Identifiers

PMID26451734
PMCPMC4778542
OpenAlexW1930304162

What OpenQuestion holds

Textmetadata
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.