Evidence map›Paper›PMID 27811070›Full record

Trial reportThe European respiratory journal2017

A randomised controlled trial of tiotropium in adolescents with severe symptomatic asthma.

Eckard Hamelmann, Jonathan A Bernstein, Mark Vandewalker, Petra Moroni-Zentgraf, Daniela Verri, Anna Unseld, Michael Engel, Attilio L Boner

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The European respiratory journal, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01277523 (A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate Efficacy and Safety of Tiotropium Inhalation Solution Delivered Via Respimat® Inhaler), which is not on this map. Cited by 38 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 6 pooled it
12.1field-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.

NCT01277523 phase3completednot on this map

A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate Efficacy and Safety of Tiotropium Inhalation Solution Delivered Via Respimat® Inhaler (2.5 mcg and 5 mcg Once Daily) Over 12 Weeks as add-on Controller Therapy on Top of Usual Care in Adolescents (12 to 17 Years Old) With Severe Persistent Asthma

TypeinterventionalSponsorBoehringer IngelheimRan2011 to 2013Enrolled392ConditionsAsthmaArmstiotropium high dose, placebo, tiotropium low dose
3 · Its place in the literature

Who cites it

38 citing papers in PubMed, 6 syntheses or guidelines pooled it, 107 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Trial
  8. Review
  9. Review
  10. Article
  11. The new era of add-on asthma treatments: where do we stand?Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology · 2022
    Review
  12. Review
  13. 2021 Brazilian Thoracic Association recommendations for the management of severe asthma.Jornal brasileiro de pneumologia : publicacao oficial da Sociedade Brasileira de Pneumologia e Tisilogia · 2021
    Review
  14. Review
  15. Review
  16. Management of Severe Asthma Beyond the Guidelines.Current allergy and asthma reports · 2020
    Review
  17. Review
  18. A comparison of tiotropium, long-acting βRespiratory research · 2020
    Review
  19. Review
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 6 institutions in 4 countries.

Eckard HamelmannKlinik für Kinder- und Jugendmedizin, Kinderzentrum Bethel, Evangelisches Krankenhaus Bielefeld, Akademisches Lehrkrankenhaus der Universität Münster, Bielefeld, Germany eckard.hamelmann@evkb.de.
Jonathan A BernsteinBernstein Allergy Group, Cincinnati, OH, USA.
Mark VandewalkerClinical Research of the Ozarks, Columbia, MO, USA.
Petra Moroni-ZentgrafBoehringer Ingelheim, Sydney, Australia.
Daniela VerriClinical Operations, Medical Department, Boehringer Ingelheim Italia, Milan, Italy.
Anna UnseldGlobal Biometrics and Data Sciences, Boehringer Ingelheim Pharma KG, Biberach an der Riss, Germany.
Michael EngelBoehringer Ingelheim, Sydney, Australia.
Attilio L BonerU.O.C. di Pediatria, Dipartimento di Scienze Chirurgiche Odontostomatologiche e Materno Infantili, Policlinico "G. Rossi", Verona, Italy.
Boehringer Ingelheim (Australia) · AUBernstein Clinical Research Center · USBoehringer Ingelheim (Germany) · DEBoehringer Ingelheim (Italy) · ITEvangelisches Krankenhaus Bielefeld · DEUniversity of the Ozarks · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

We present results from the first phase III trial of once-daily tiotropium add-on to inhaled corticosteroids (ICS) plus one or more controller therapies in adolescents with severe symptomatic asthma.In this double-blind, parallel-group trial (NCT01277523), 392 patients aged 12-17 years were randomised to receive once-daily tiotropium 5 µg or 2.5 µg, or placebo, as an add-on to ICS plus other controller therapies over 12 weeks. The primary and key secondary end-points were change from baseline (response) in peak forced expiratory volume in 1 s (FEV

Indexed as

Administration, InhalationAdolescentAdrenal Cortex HormonesAsthmaChildCholinergic AntagonistsDouble-Blind MethodDrug Therapy, CombinationFemaleForced Expiratory VolumeHumansInternational CooperationMaleProportional Hazards ModelsTiotropium BromideTreatment OutcomeAdrenal Cortex HormonesCholinergic AntagonistsTiotropium Bromide

Identifiers

PMID27811070
PMCPMC5298196
OpenAlexW2546744840

What OpenQuestion holds

Textmetadata
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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.