Evidence map›Paper›PMID 26082625›Full record

Trial reportInternational journal of chronic obstructive pulmonary disease2015

LANTERN: a randomized study of QVA149 versus salmeterol/fluticasone combination in patients with COPD.

Nanshan Zhong, Changzheng Wang, Xiangdong Zhou, Nuofu Zhang, Michael Humphries, Linda Wang, Chau Thach, Francesco Patalano, Donald Banerji, LANTERN Investigators

Open access · goldAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International journal of chronic obstructive pulmonary disease, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 81 papers, 16 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
81citing papers in PubMed, 16 pooled it
24.4field-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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

81 citing papers in PubMed, 16 syntheses or guidelines pooled it, 160 citations in OpenAlex.

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  14. LABA/LAMA fixed-dose combinations in patients with COPD: a systematic review.International journal of chronic obstructive pulmonary disease
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21 more citing papers are in PubMed but not listed here.

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

10 authors at 4 institutions in 3 countries.

Nanshan ZhongState Key Laboratory of Respiratory Diseases, First Affiliated Hospital, Guangzhou Medical University, Guangzhou, Guangdong, People's Republic of China.
Changzheng WangInstitute of Respiratory Disease, Xin Qiao Hospital, Third Military Medical University, Chongqing City, Chongqing, People's Republic of China.
Xiangdong ZhouDepartment of Respiratory Medicine, Southwest Hospital, Third Military Medical University, Chongqing City, Chongqing, People's Republic of China.
Nuofu ZhangState Key Laboratory of Respiratory Diseases, First Affiliated Hospital, Guangzhou Medical University, Guangzhou, Guangdong, People's Republic of China.
Michael HumphriesBeijing Novartis Pharma Co. Ltd., Shanghai, People's Republic of China.
Linda WangBeijing Novartis Pharma Co. Ltd., Shanghai, People's Republic of China.
Chau ThachNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Francesco PatalanoNovartis Pharma AG, Basel, Switzerland.
Donald BanerjiNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
LANTERN Investigators
Novartis (China) · CNNovartis (Switzerland) · CHNovartis (United States) · USTris Pharma (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe current Global initiative for chronic Obstructive Lung Disease (GOLD) treatment strategy recommends the use of one or more bronchodilators according to the patient's airflow limitation, their history of exacerbations, and symptoms. The LANTERN study evaluated the effect of the long-acting β2-agonist (LABA)/long-acting muscarinic antagonist (LAMA) dual bronchodilator, QVA149 (indacaterol/glycopyrronium), as compared with the LABA/inhaled corticosteroid, salmeterol/fluticasone (SFC), in patients with moderate-to-severe COPD with a history of ≤1 exacerbation in the previous year.

methodsIn this double-blind, double-dummy, parallel-group study, 744 patients with moderate-to-severe COPD with a history of ≤1 exacerbations in the previous year were randomized (1:1) to QVA149 110/50 μg once daily or SFC 50/500 μg twice daily for 26 weeks. The primary endpoint was noninferiority of QVA149 versus SFC for trough forced expiratory volume in 1 second (FEV1) at week 26.

resultsOverall, 676 patients completed the study. The primary objective of noninferiority between QVA149 and SFC in trough FEV1 at week 26 was met. QVA149 demonstrated statistically significant superiority to SFC for trough FEV1 (treatment difference [Δ]=75 mL; P<0.001). QVA149 demonstrated a statistically significant improvement in standardized area under the curve (AUC) from 0 hours to 4 hours for FEV1 (FEV1 AUC0-4h) at week 26 versus SFC (Δ=122 mL; P<0.001). QVA149 and SFC had similar improvements in transition dyspnea index focal score, St George Respiratory Questionnaire total score, and rescue medication use. However, QVA149 significantly reduced the rate of moderate or severe exacerbations by 31% (P=0.048) over SFC. Overall, the incidence of adverse events was comparable between QVA149 (40.1%) and SFC (47.4%). The incidence of pneumonia was threefold lower with QVA149 (0.8%) versus SFC (2.7%).

conclusionThese findings support the use of the LABA/LAMA, QVA149 as an alternative treatment, over LABA/inhaled corticosteroid, in the management of moderate-to-severe COPD patients (GOLD B and GOLD D) with a history of ≤1 exacerbation in the previous year.

Indexed as

Administration, InhalationAdrenergic beta-2 Receptor AgonistsAdultAgedBronchodilator AgentsDouble-Blind MethodDrug CombinationsFemaleFluticasone-Salmeterol Drug CombinationForced Expiratory VolumeGlucocorticoidsGlycopyrrolateHumansIndansLungMaleAdrenergic beta-2 Receptor AgonistsBronchodilator AgentsDrug CombinationsFluticasone-Salmeterol Drug CombinationGlucocorticoidsGlycopyrrolateindacaterol-glycopyrronium combinationIndansMuscarinic AntagonistsQuinolonesclinical trialCOPDlong-acting muscarinic antagonistlong-acting β2-agonists

Identifiers

PMID26082625
PMCPMC4461092
OpenAlexW1637753636

What OpenQuestion holds

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Registered trials

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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.