Evidence map›Paper›PMID 26316741›Full record

Trial reportInternational journal of chronic obstructive pulmonary disease2015

Efficacy and safety of the long-acting β2-agonist olodaterol over 4 weeks in Japanese patients with chronic obstructive pulmonary disease.

Masakazu Ichinose, Ayako Takizawa, Toshiyasu Izumoto, Yusuke Tadayasu, Alan L Hamilton, Christina Kunz, Yoshinosuke Fukuchi

Registry-linked trialAbstract readMulticenter 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. It is linked to trial NCT00824382 (Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of 4 Weeks of Once Daily Treatment of Orally Inhaled BI 1744 CL Delivered by the Respimat Inhaler in Japanese Patients With COPD), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 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.

NCT00824382 phase2completednot on this map

Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of 4 Weeks of Once Daily Treatment of Orally Inhaled BI 1744 CL Delivered by the Respimat Inhaler in Japanese Patients With COPD

TypeinterventionalSponsorBoehringer IngelheimRan2009Enrolled328ConditionsPulmonary Disease, Chronic ObstructiveArmsBI 1744 CL 2 µg, BI 1744 CL 5 µg, BI 1744 CL 10 µg, Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
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.

Masakazu IchinoseDepartment of Respiratory Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan.
Ayako TakizawaNippon Boehringer Ingelheim Co. Ltd, Tokyo, Japan.
Toshiyasu IzumotoNippon Boehringer Ingelheim Co. Ltd, Tokyo, Japan.
Yusuke TadayasuNippon Boehringer Ingelheim Co. Ltd, Tokyo, Japan.
Alan L HamiltonBoehringer Ingelheim, Burlington, Ontario, Canada.
Christina KunzBoehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riß, Germany.
Yoshinosuke FukuchiJuntendo University School of Medicine, Tokyo, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOlodaterol is a novel long-acting β2-agonist with proven ≥24-hour duration of action in preclinical and clinical studies.

objectiveThis randomized, double-blind, placebo-controlled, parallel-group study evaluated the dose response of once-daily (QD) olodaterol based on bronchodilator efficacy, safety, and pharmacokinetics over 4 weeks in Japanese patients with chronic obstructive pulmonary disease (COPD).

methodsAll eligible patients were randomized to receive 2 µg, 5 µg, or 10 µg of olodaterol or placebo for 4 weeks via the Respimat Soft Mist inhaler. The primary end point was the change from baseline in trough forced expiratory volume in 1 second (FEV1) after 4 weeks of olodaterol treatment. Secondary end points included trough FEV1 after 1 week and 2 weeks of treatment, FEV1 area under the curve from 0 hour to 3 hours (AUC(0-3)), peak FEV1 from 0 hour to 3 hours (peak FEV1), and corresponding forced vital capacity (FVC) responses. Rescue medication use, COPD symptoms, physician global evaluation, pharmacokinetics, and safety were also assessed.

resultsA total of 328 patients with COPD were randomized to receive treatment. All olodaterol doses assessed in the study showed statistically significant increases in trough FEV1 compared to placebo at Day 29 (P<0.0001). Mean increases in peak FEV1 and FEV1 AUC(0-3) compared to placebo were also significant (P<0.0001). A clear dose-response relationship was observed across all treatment groups. FVC responses (trough and FVC AUC(0-3)) supported FEV1 outcomes. All doses of olodaterol were well tolerated, and no safety concerns were identified.

conclusionQD olodaterol demonstrated 24-hour bronchodilator efficacy and was well tolerated in Japanese patients with COPD.

trial registrationClinicalTrials.gov: NCT00824382.

Indexed as

Administration, InhalationAdrenergic beta-2 Receptor AgonistsAgedArea Under CurveBenzoxazinesBronchodilator AgentsDouble-Blind MethodDrug Administration ScheduleFemaleForced Expiratory VolumeHumansJapanLungMaleMiddle AgedNebulizers and VaporizersAdrenergic beta-2 Receptor AgonistsBenzoxazinesBronchodilator Agentsolodateroldose-findingonce-dailyplasma concentrationpulmonary functiontrough FEV1trough FVC

Identifiers

PMID26316741
PMCPMC4548739

What OpenQuestion holds

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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.