Evidence map›Paper›PMID 20979471›Full record

Trial reportThe New England journal of medicine2010

Tiotropium bromide step-up therapy for adults with uncontrolled asthma.

Stephen P Peters, Susan J Kunselman, Nikolina Icitovic, Wendy C Moore, Rodolfo Pascual, Bill T Ameredes, Homer A Boushey, William J Calhoun, Mario Castro, Reuben M Cherniack and 24 more

4 registry-linked trialsOpen access · bronzeAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The New England journal of medicine, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 161 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
161citing papers in PubMed, 10 pooled it
30.6field-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.

NCT00565266 phase3completednot on this map

Asthma Clinical Research Network (ACRN) Trial - Tiotropium Bromide as an Alternative to Increased Inhaled Corticosteroid in Patients Inadequately Controlled on a Lower Dose of Inhaled Corticosteroid (TALC)

TypeinterventionalSponsorMilton S. Hershey Medical CenterRan2008 to 2010Enrolled210ConditionsAsthmaArmstiotropium bromide, salmeterol xinafoate, beclomethasone dipropionate
NCT02836691 nacompletednot on this mapstarted 2016, after this paper: background citation

Autonomic Nervous System Role in Uncontrolled ASTHMA and the Paucigranulocitic Phenotype

TypeinterventionalSponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauRan2016 to 2019Enrolled40ConditionsAsthmaArmsEKG (electrocardiogram)
NCT03084718 phase2completednot on this mapstarted 2017, after this paper: background citation

An 8-week, Multicenter, Randomized, Double-blind, Placebo and Active-controlled, Parallel Group, Dose-ranging Study to Evaluate the Efficacy and Safety of 3 Doses of CHF 718 pMDI (HFA Beclomethasone Dipropionate Via Pressured Metered Dose Inhaler) in Asthmatic Subjects.

TypeinterventionalSponsorChiesi Farmaceutici S.p.A.Ran2017 to 2018Enrolled610ConditionsAsthmaArmsCHF 718 pMDI, Placebo pMDI, Beclomethasone Dipropionate (BDP)
NCT04129931 phase2completednot on this mapstarted 2019, after this paper: background citation

PrecISE (Precision Interventions for Severe and/or Exacerbation-Prone Asthma) Network Study

TypeinterventionalSponsorUniversity of North Carolina, Chapel HillRan2019 to 2025Enrolled950ConditionsAsthmaArmsMCT, Clazakizumab, Broncho-Vaxom, Imatinib Mesylate, Cavosonstat
3 · Its place in the literature

Who cites it

161 citing papers in PubMed, 10 syntheses or guidelines pooled it, 510 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Pooled it
  10. Guideline
  11. Trial
  12. Trial
  13. Trial
  14. Trial
  15. Trial
  16. Obesity's effect on asthma extends to diagnostic criteria.The Journal of allergy and clinical immunology · 2018
    Trial
  17. Therapeutic Effects of a Long-Acting Cholinergic Receptor Blocker, Tiotropium Bromide, on Asthma.Medical science monitor : international medical journal of experimental and clinical research · 2018
    Trial
  18. Trial
  19. Population Pharmacokinetics Modeling of Inhaled Umeclidinium for Adult Patients with Asthma.European journal of drug metabolism and pharmacokinetics · 2017
    Trial
  20. Trial

101 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

34 authors at 11 institutions in 1 country.

Stephen P PetersWake Forest University Health Sciences, Center for Genomics and Personalized Medicine Research, Medical Center Blvd., Winston-Salem, NC 27157, USA. sppeters@wfubmc.edu
Susan J Kunselman
Nikolina Icitovic
Wendy C Moore
Rodolfo Pascual
Bill T Ameredes
Homer A Boushey
William J Calhoun
Mario Castro
Reuben M Cherniack
Timothy Craig
Loren Denlinger
Linda L Engle
Emily A DiMango
John V Fahy
Elliot Israel
Nizar Jarjour
Shamsah D Kazani
Monica Kraft
Stephen C Lazarus
Robert F Lemanske
Njira Lugogo
Richard J Martin
Deborah A Meyers
Joe Ramsdell
Christine A Sorkness
E Rand Sutherland
Stanley J Szefler
Stephen I Wasserman
Michael J Walter
Michael E Wechsler
Vernon M Chinchilli
Eugene R Bleecker
National Heart, Lung, and Blood Institute Asthma Clinical Research Network
Penn State Milton S. Hershey Medical Center · USWake Forest University · USUniversity of Colorado Denver · USHarvard University · USDuke University · USMadison County Public Schools · USThe University of Texas Medical Branch at Galveston · USWashington University in St. Louis · USColumbia University Irving Medical Center · USMadison Group (United States) · USUniversity of Wisconsin–Madison · US

Funding

Washington University Institute of Clinical and Translational SciencesUL1TR000448 · NCATS · WASHINGTON UNIVERSITY · PI EVANOFF, BRADLEY A · 2012 to 2016
$41.4M
ACRN Data Coordinating CenterU10HL074231 · NHLBI · PENNSYLVANIA STATE UNIV HERSHEY MED CTR · PI CHINCHILLI, VERNON M. · 2003 to 2007
$13.3M
Informative Clinical Studies in AsthmaU10HL074227 · NHLBI · BRIGHAM AND WOMEN'S HOSPITAL · PI ISRAEL, ELLIOT · 2003 to 2007
$5.8M
Treatment of Severe Persistent AsthmaU10HL074212 · NHLBI · UNIVERSITY OF WISCONSIN-MADISON · PI LEMANSKE, ROBERT F · 2003 to 2007
$4.9M
Innovative Investigations and Therapies for AsthmaU10HL074073 · NHLBI · NATIONAL JEWISH HEALTH · PI MARTIN, RICHARD J · 2003 to 2007
$3.9M
Asthma Clinical Research Network Center at UCSFU10HL074204 · NHLBI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI BOUSHEY, HOMER A · 2003 to 2007
$3.8M
Asthma Clinical Research NetworkU10HL074206 · NHLBI · UNIVERSITY OF TEXAS MEDICAL BR GALVESTON · PI CALHOUN, WILLIAM J · 2003 to 2008
$3.6M
Asthma Clinical Research Network-Washington UniversityU10HL074208 · NHLBI · WASHINGTON UNIVERSITY · PI CASTRO, MARIO · 2003 to 2007
$3.4M
ASTHMA CLINICAL RESEARCH NETWORKU10HL074218 · NHLBI · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI WASSERMAN, STEPHEN I · 2003 to 2012
$3.3M
Asthma Clinical Research Network (ACRN)U10HL074225 · NHLBI · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI PETERS, STEPHEN P · 2003 to 2007
$3.2M
NCATS NIH HHS UL1 TR000448NHLBI NIH HHS U10 HL074073NHLBI NIH HHS U10 HL074204NHLBI NIH HHS U10 HL074206NHLBI NIH HHS U10 HL074208NHLBI NIH HHS U10 HL074212NHLBI NIH HHS U10 HL074218NHLBI NIH HHS U10 HL074225NHLBI NIH HHS U10 HL074227NHLBI NIH HHS U10 HL074231
6 · The paper itself

Abstract

backgroundLong-acting beta-agonist (LABA) therapy improves symptoms in patients whose asthma is poorly controlled by an inhaled glucocorticoid alone. Alternative treatments for adults with uncontrolled asthma are needed.

methodsIn a three-way, double-blind, triple-dummy crossover trial involving 210 patients with asthma, we evaluated the addition of tiotropium bromide (a long-acting anticholinergic agent approved for the treatment of chronic obstructive pulmonary disease but not asthma) to an inhaled glucocorticoid, as compared with a doubling of the dose of the inhaled glucocorticoid (primary superiority comparison) or the addition of the LABA salmeterol (secondary noninferiority comparison).

resultsThe use of tiotropium resulted in a superior primary outcome, as compared with a doubling of the dose of an inhaled glucocorticoid, as assessed by measuring the morning peak expiratory flow (PEF), with a mean difference of 25.8 liters per minute (P<0.001) and superiority in most secondary outcomes, including evening PEF, with a difference of 35.3 liters per minute (P<0.001); the proportion of asthma-control days, with a difference of 0.079 (P=0.01); the forced expiratory volume in 1 second (FEV1) before bronchodilation, with a difference of 0.10 liters (P=0.004); and daily symptom scores, with a difference of -0.11 points (P<0.001). The addition of tiotropium was also noninferior to the addition of salmeterol for all assessed outcomes and increased the prebronchodilator FEV1 more than did salmeterol, with a difference of 0.11 liters (P=0.003).

conclusionsWhen added to an inhaled glucocorticoid, tiotropium improved symptoms and lung function in patients with inadequately controlled asthma. Its effects appeared to be equivalent to those with the addition of salmeterol. (Funded by the National Heart, Lung, and Blood Institute; ClinicalTrials.gov number, NCT00565266.).

Indexed as

Administration, InhalationAdultAlbuterolAsthmaBeclomethasoneBronchodilator AgentsCholinergic AntagonistsCross-Over StudiesDouble-Blind MethodDrug Therapy, CombinationFemaleGlucocorticoidsHumansMalePeak Expiratory Flow RateSalmeterol XinafoateAlbuterolBeclomethasoneBronchodilator AgentsCholinergic AntagonistsGlucocorticoidsSalmeterol XinafoateScopolamine DerivativesTiotropium Bromide

Identifiers

PMID20979471
PMCPMC3011177
OpenAlexW2126325768

What OpenQuestion holds

Textmetadata
LicenceTDM
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.