Evidence map›Paper›PMID 26893551›Full record

Trial reportInternational journal of chronic obstructive pulmonary disease2016

The lung function profile of once-daily tiotropium and olodaterol via Respimat(®) is superior to that of twice-daily salmeterol and fluticasone propionate via Accuhaler(®) (ENERGITO(®) study).

Kai-Michael Beeh, Eric Derom, José Echave-Sustaeta, Lars Grönke, Alan Hamilton, Dongmei Zhai, Leif Bjermer

Open access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International journal of chronic obstructive pulmonary disease, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 50 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
50citing papers in PubMed, 8 pooled it
12.3field-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

50 citing papers in PubMed, 8 syntheses or guidelines pooled it, 105 citations in OpenAlex.

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  14. Exacerbation heterogeneity in COPD: subgroup analyses from the FLAME study.International journal of chronic obstructive pulmonary disease
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 6 institutions in 5 countries.

Kai-Michael BeehInsaf GmbH Institut für Atemwegsforschung, Wiesbaden, Germany.
Eric DeromDepartment of Internal Medicine, Ghent University Hospital, Ghent, Belgium.
José Echave-SustaetaServicio de Neumología, Hospital Universitario Quirón, Madrid, Spain.
Lars GrönkeBoehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
Alan HamiltonBoehringer Ingelheim, Burlington, ON, Canada.
Dongmei ZhaiInVentiv Health Clinical, Wilmington, DE, USA.
Leif BjermerDepartment of Respiratory Medicine and Allergology, Lund University, Lund, Sweden.
Boehringer Ingelheim (Canada) · CABoehringer Ingelheim (Germany) · DEGhent University Hospital · BEHospital Universitario Quirónsalud Madrid · ESLund University · SERespiratory Research Institute · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTiotropium + olodaterol has demonstrated improvements beyond lung function benefits in a large Phase III clinical program as a once-daily maintenance treatment for COPD and may be a potential option for the initiation of maintenance treatment in COPD. Despite guideline recommendations that combined long-acting β2-agonists and inhaled corticosteroids should only be used in individuals at high risk of exacerbation, there is substantial use in individuals at lower risk. This raises the question of the comparative effectiveness of this combination as maintenance treatment in this group compared to other combination regimens.

objectiveThe study aimed to assess the effect on lung function of once-daily tiotropium + olodaterol versus twice-daily salmeterol + fluticasone propionate in all participants with Global initiative for chronic Obstructive Lung Disease 2 or 3 (moderate to severe) COPD.

methodsThis was a randomized, double-blind, double-dummy, four-treatment, complete crossover study in which participants received once-daily tiotropium + olodaterol (5/5 µg and 2.5/5 µg) via Respimat(®) and twice-daily salmeterol + fluticasone propionate (50/500 µg and 50/250 µg) via Accuhaler(®) for 6 weeks. The primary end point was change in forced expiratory volume in 1 second (FEV1) area under the curve from 0 hour to 12 hours (AUC0-12) relative to the baseline after 6 weeks.

resultsTiotropium + olodaterol 5/5 µg and 2.5/5 µg demonstrated statistically significant improvements in FEV1 AUC0-12 compared to salmeterol + fluticasone propionate (improvements from baseline were 317 mL and 295 mL with tiotropium + olodaterol 5/5 µg and 2.5/5 µg, and 188 mL and 192 mL with salmeterol + fluticasone propionate 50/500 µg and 50/250 µg, respectively). Tiotropium + olodaterol was superior to salmeterol + fluticasone propionate in lung function secondary end points, including FEV1 area under the curve from 0 hour to 24 hours (AUC0-24).

conclusionOnce-daily tiotropium + olodaterol in participants with moderate-to-severe COPD provided superior lung function improvements to twice-daily salmeterol + fluticasone propionate. Dual bronchodilation can be considered to optimize lung function in individuals requiring maintenance treatment for COPD.

Indexed as

Pulmonary Disease, Chronic ObstructiveAdministration, InhalationAgedBenzoxazinesBronchodilator AgentsDouble-Blind MethodDrug Administration ScheduleDrug CombinationsDrug MonitoringFemaleFluticasoneHumansMaleMiddle AgedNebulizers and VaporizersRespiratory Function TestsBenzoxazinesBronchodilator AgentsDrug CombinationsFluticasoneolodaterolSalmeterol XinafoateTiotropium BromideCOPDFEV1inhaled corticosteroidlung functionmaintenance treatmenttiotropium

Identifiers

PMID26893551
PMCPMC4745834
OpenAlexW2267101752

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.