Evidence map›Paper›PMID 24966672›Full record

Trial reportInternational journal of chronic obstructive pulmonary disease2014

Efficacy and safety of olodaterol once daily delivered via Respimat® in patients with GOLD 2-4 COPD: results from two replicate 48-week studies.

Gary T Ferguson, Gregory J Feldman, Peter Hofbauer, Alan Hamilton, Lisa Allen, Lawrence Korducki, Paul Sachs

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International journal of chronic obstructive pulmonary disease, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 48 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
48citing papers in PubMed, 10 pooled it
–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.

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

48 citing papers in PubMed, 10 syntheses or guidelines pooled it.

  1. Joint longitudinal model-based meta-analysis of FEVJournal of pharmacokinetics and pharmacodynamics · 2023
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  13. Tiotropium/olodaterol versus tiotropium in Japanese patients with COPD: results from the DYNAGITO study.International journal of chronic obstructive pulmonary disease · 2018
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  14. Long-term safety of tiotropium/olodaterol RespimatInternational journal of chronic obstructive pulmonary disease · 2018
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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

7 authors.

Gary T FergusonPulmonary Research Institute of Southeast Michigan, Livonia, MI, USA.
Gregory J FeldmanS Carolina Pharmaceutical Research, Spartanburg, SC, USA.
Peter HofbauerPneumologie, Weinheim, Germany.
Alan HamiltonBoehringer Ingelheim, Burlington, ON, Canada.
Lisa AllenBoehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA.
Lawrence KorduckiBoehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA.
Paul SachsPulmonary Associates of Stamford, Stamford, CT, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOlodaterol is a long-acting β2-agonist with a 24-hour bronchodilator profile. Two replicate, randomized, double-blind, placebo-controlled, parallel-group, Phase III trials were performed as part of a comprehensive clinical program to investigate the long-term safety and efficacy of olodaterol in patients with moderate to very severe chronic obstructive pulmonary disease (COPD) receiving usual-care background therapy.

methodsPatients received olodaterol 5 μg or 10 μg or placebo once daily for 48 weeks. Coprimary end points were forced expiratory volume in 1 second (FEV1) area under the curve from 0 to 3 hours (AUC0-3) response (change from baseline), and trough FEV1 response at 12 weeks. Secondary end points included additional lung function assessments, use of rescue medications, FEV1 AUC response from 0 to 12 hours, and Patient Global Rating over 48 weeks.

resultsOverall, 624 and 642 patients were evaluated in studies 1222.11 and 1222.12, respectively. In both studies, olodaterol 5 μg and 10 μg significantly improved the FEV1 AUC0-3 response (P<0.0001) and trough FEV1 (study 1222.11, P<0.0001; study 1222.12, P<0.05, post hoc) at week 12, with an incidence of adverse events comparable with that of placebo. Secondary end points supported the efficacy of olodaterol.

conclusionThese studies demonstrate the long-term efficacy and safety of once-daily olodaterol 5 μg and 10 μg in patients with moderate to very severe COPD continuing with usual-care maintenance therapy.

Indexed as

Nebulizers and VaporizersAdministration, InhalationAdrenergic beta-2 Receptor AgonistsAgedArea Under CurveAsiaAustraliaBenzoxazinesBronchodilator AgentsDouble-Blind MethodEquipment DesignFemaleForced Expiratory VolumeGermanyHumansLungAdrenergic beta-2 Receptor AgonistsBenzoxazinesBronchodilator Agentsolodaterolbronchodilatorchronic obstructive pulmonary diseaseolodaterol

Identifiers

PMID24966672
PMCPMC4064950

What OpenQuestion holds

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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.