Evidence map›Paper›PMID 22743678›Full record

Trial reportThe European respiratory journal2013

A phase II placebo-controlled study of tralokinumab in moderate-to-severe asthma.

Edward Piper, Christopher Brightling, Robert Niven, Chad Oh, Raffaella Faggioni, Kwai Poon, Dewei She, Chris Kell, Richard D May, Gregory P Geba and 1 more

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The European respiratory journal, 2013. 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 131 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
131citing papers in PubMed, 10 pooled it
21.2field-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.

NCT00873860 phase2completednot on this map

A Phase 2a, Randomized, Double-blind, Placebo-Controlled, Parallel-Arm, Multicenter Study to Evaluate the Efficacy and Safety of CAT-354, a Recombinant Human Monoclonal Antibody Directed Against Interleukin-13 (IL-13), on Asthma Control in Adults With Uncontrolled, Moderate-to-severe, Persistent Asthma

TypeinterventionalSponsorMedImmune LLCRan2009 to 2010Enrolled357ConditionsAsthmaArmsPlacebo, CAT-354 150 mg, CAT-354 300 mg, CAT-354 600 mg
NCT04556461 phase2completednot on this mapstarted 2020, after this paper: background citation

Effects of Tralokinumab Treatment of Atopic Dermatitis on Skin Barrier Function

TypeinterventionalSponsorProf. Dr. Stephan WeidingerRan2020 to 2023Enrolled16ConditionsAtopic DermatitisArmsTralokinumab
3 · Its place in the literature

Who cites it

131 citing papers in PubMed, 10 syntheses or guidelines pooled it, 371 citations in OpenAlex.

  1. Pooled it
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  3. Anti-IL-5 therapies for asthma.The Cochrane database of systematic reviews · 2022
    Pooled it
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  8. Anti-IL5 therapies for asthma.The Cochrane database of systematic reviews · 2017
    Pooled it
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  10. Omalizumab for asthma in adults and children.The Cochrane database of systematic reviews · 2014
    Pooled it
  11. Trial
  12. Trial
  13. Article
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  15. Article
  16. Review
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71 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 3 institutions in 1 country.

Edward PiperClinical Development, MedImmune Ltd., Granta Park, Cambridge, UK. pipered@medimmune.com
Christopher Brightling
Robert Niven
Chad Oh
Raffaella Faggioni
Kwai Poon
Dewei She
Chris Kell
Richard D May
Gregory P Geba
Nestor A Molfino
PredictImmune · GBUniversity of Leicester · GBUniversity of Manchester · GB

Funding

Wellcome Trust 082265
6 · The paper itself

Abstract

Pre-clinical data demonstrate a pivotal role for interleukin (IL)-13 in the development and maintenance of asthma. This study assessed the effects of tralokinumab, an investigational human IL-13-neutralising immunoglobulin G4 monoclonal antibody, in adults with moderate-to-severe uncontrolled asthma despite controller therapies. 194 subjects were randomised to receive tralokinumab (150, 300 or 600 mg) or placebo subcutaneously every 2 weeks. Primary end-point was change from baseline in mean Asthma Control Questionnaire score (ACQ-6; ACQ mean of six individual item scores) at week 13 comparing placebo and combined tralokinumab dose groups. Secondary end-points included pre-bronchodilator lung function, rescue β(2)-agonist use and safety. Numerical end-points are reported as mean±sd. At week 13, change from baseline in ACQ-6 was -0.76±1.04 for tralokinumab versus -0.61±0.90 for placebo (p=0.375). Increases from baseline in forced expiratory volume in 1 s (FEV(1)) were 0.21±0.38 L versus 0.06±0.48 L (p=0.072), with a dose-response observed across the tralokinumab doses tested. β(2)-agonist use (puffs per day) was decreased for tralokinumab -0.68±1.45 versus placebo -0.10±1.49 (p=0.020). The increase in FEV(1) following tralokinumab treatment remained evident 12 weeks after the final dose. Safety profile was acceptable with no serious adverse events related to tralokinumab. No improvement in ACQ-6 was observed, although tralokinumab treatment was associated with improved lung function.

Indexed as

AdolescentAdultAgedAntibodies, MonoclonalAsthmaDouble-Blind MethodFemaleHumansImmunoglobulin GInterleukin-13MaleMiddle AgedModels, StatisticalRespiratory Function TestsSurveys and QuestionnairesTreatment OutcomeAntibodies, MonoclonalImmunoglobulin GInterleukin-13tralokinumab

Identifiers

PMID22743678
PMCPMC3561510
OpenAlexW2153395214

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.