Evidence map›Paper›PMID 25187881›Full record

ArticleSpringerPlus2014

The 24-h FEV1 time profile of olodaterol once daily via Respimat® and formoterol twice daily via Aerolizer® in patients with GOLD 2-4 COPD: results from two 6-week crossover studies.

Gregory J Feldman, Jonathan A Bernstein, Alan Hamilton, Michael C Nivens, Lawrence Korducki, Craig LaForce

2 registry-linked trialsOpen access · diamondAbstract read
In one paragraph

Article in SpringerPlus, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 26 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 3 pooled it
8.2field-weighted citation impact, top 2% 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.

NCT00931385 phase3completednot on this map

Characterisation of 24-hour FEV1-time Profiles of Inhaled BI 1744 CL and Inhaled Foradil Iin Patients With Chronic Obstructive Pulmonary Disease

TypeinterventionalSponsorBoehringer IngelheimRan2009Enrolled99ConditionsPulmonary Disease, Chronic ObstructiveArmsBI 1744, bi1744, Placebo, Foradil
NCT00932646 phase3completednot on this map

Characterization of 24 Hour Spirometry Profiles of Inhaled BI 1744 CL and Inhaled Foradil in Patients With Chronic Obstructive Pulmonary Disease

TypeinterventionalSponsorBoehringer IngelheimRan2009Enrolled100ConditionsPulmonary Disease, Chronic ObstructiveArmsBI 1744 (Olodaterol) Low Dose, BI 1744 (Olodaterol) Medium Dose, Placebo, Foradil
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 3 syntheses or guidelines pooled it, 40 citations in OpenAlex.

  1. Pooled it
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  3. Pooled it
  4. 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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  18. Efficacy and safety of tiotropium + olodaterol maintenance treatment in patients with COPD in the TONADOInternational journal of chronic obstructive pulmonary disease · 2016
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  19. A review of nebulized drug delivery in COPD.International journal of chronic obstructive pulmonary disease · 2016
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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

6 authors at 2 institutions in 2 countries.

Gregory J FeldmanS. Carolina Pharmaceutical Research, 141 Harold Fleming Court, North Grove Medical Park, Spartanburg, South Carolina 29303 USA.
Jonathan A BernsteinDepartment of Internal Medicine, Bernstein Clinical Research Center, Cincinnati, Ohio USA.
Alan HamiltonBoehringer Ingelheim, Burlington, Ontario Canada.
Michael C NivensBoehringer Ingelheim Pharmaceuticals Inc, Biberach an der Riss, Germany.
Lawrence KorduckiBoehringer Ingelheim Pharma GmbH & Co. KG, Ridgefield, Connecticut USA.
Craig LaForceNorth Carolina Clinical Research, Raleigh, North Carolina USA.
Boehringer Ingelheim (Canada) · CABoehringer Ingelheim (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

abstractThese studies evaluated the 24-h forced expiratory volume in 1 sec (FEV1) profile of once-daily (QD) olodaterol compared to placebo and twice-daily (BID) formoterol in patients with moderate to very severe chronic obstructive pulmonary disease. In two replicate, randomized, double-blind, double-dummy, four-way crossover studies, patients received olodaterol 5 and 10 μg QD, formoterol 12 μg BID, or placebo for 6 weeks in addition to usual-care background maintenance therapy. Co-primary end points were FEV1 area under the curve from 0-12 h (AUC0-12) response (change from baseline) and FEV1 AUC from 12-24 h (AUC12-24) response after 6 weeks, with FEV1 AUC from 0-24 h response identified as a key secondary end point. Other secondary end points included FEV1 AUC from 0-3 h and trough FEV1 responses, as well as corresponding forced vital capacity responses. With both olodaterol doses, FEV1 increased to near-maximal 30 min post-morning dose, which was sustained over 24 h. FEV1 also increased within 30 min post-morning dose of formoterol and was sustained over 12 h; the second formoterol dose resulted in a further increase, sustained for an additional 12 h. FEV1 AUC0-12 and AUC12-24 responses with both QD olodaterol doses and BID formoterol were significantly greater than placebo at 6 weeks (P < .0001). Secondary end-point outcomes were consistent with those of the co-primary end points. These data, together with those from the wider phase III clinical program, provide evidence for the 24-h bronchodilator efficacy of olodaterol QD in this patient population. TRIAL REGISTRY: ClinicalTrials.gov; NCT00931385 and NCT00932646.

Identifiers

PMID25187881
PMCPMC4152473
OpenAlexW2118132357

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.