Evidence map›Paper›PMID 31319851›Full record

SynthesisRespiratory research2019

Peak expiratory flow as an endpoint for clinical trials in asthma: a comparison with FEV

David M G Halpin, Eli O Meltzer, Wendelgard Pisternick-Ruf, Petra Moroni-Zentgraf, Michael Engel, Liliana Zaremba-Pechmann, Thomas Casale, J Mark FitzGerald

8 registry-linked trialsOpen access · goldAbstract readComparative StudyMeta-Analysis
In one paragraph

Synthesis in Respiratory research, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 8 registered trials, which are not on this map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
1.6field-weighted citation impact, top 17% 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.

NCT00772538 phase3completednot on this map

A Phase III Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate Efficacy and Safety of Tiotropium Inhalation Solution Delivered Via Respimat® Inhaler (5 mcg/Day) Over 48 Weeks as add-on Controller Therapy on Top of Usual Care in Patients With Severe Persistent Asthma

TypeinterventionalSponsorBoehringer IngelheimRan2008Enrolled459ConditionsAsthmaArmstiotropium 5mcg/day, placebo
NCT00776984 phase3completednot on this map

A Phase III Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate Efficacy and Safety of Tiotropium Inhalation Solution Delivered Via Respimat® Inhaler (5 mcg/Day) Over 48 Weeks as add-on Controller Therapy on Top of Usual Care in Patients With Severe Persistent Asthma

TypeinterventionalSponsorBoehringer IngelheimRan2008Enrolled453ConditionsAsthmaArmstiotropium 5mcg/day, placebo
NCT01172808 phase3completednot on this map

A Phase III Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate Efficacy and Safety of Tiotropium Inhalation Solution Delivered Via Respimat® Inhaler (2.5 and 5 µg Once Daily) Compared With Placebo and Salmeterol HFA MDI (50 µg Twice Daily) Over 24 Weeks in Moderate Persistent Asthma

TypeinterventionalSponsorBoehringer IngelheimRan2010 to 2012Enrolled1,071ConditionsAsthmaArmsPlacebo, tiotropium Respimat® low dose, tiotropium Respimat® high dose, 50 mcg salmeterol HFA MDI
NCT01172821 phase3completednot on this map

A Phase III Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate Efficacy and Safety of Tiotropium Inhalation Solution Delivered Via Respimat® Inhaler (2.5 and 5 µg Once Daily) Compared With Placebo and Salmeterol HFA MDI (50 µg Twice Daily) Over 24 Weeks in Moderate Persistent Asthma

TypeinterventionalSponsorBoehringer IngelheimRan2010 to 2012Enrolled1,032ConditionsAsthmaArmsplacebo, tiotropium Respimat® low dose, tiotropium Respimat® high dose, 50 mcg salmeterol HFA MDI
NCT01257230 phase3completednot on this map

A Phase III, Randomised, Double Blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety Over 48 Weeks of Orally Inhaled Tiotropium Bromide (2.5 and 5 µg Once Daily ) Delivered by the Respimat® Inhaler in Adolescents (12 to 17 Years Old) With Moderate Persistent Asthma.

TypeinterventionalSponsorBoehringer IngelheimRan2010 to 2013Enrolled398ConditionsAsthmaArmstiotropium Respimat low dose, placebo Respimat, tiotropium Respimat high dose
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
NCT01316380 phase3completednot on this map

A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate Efficacy and Safety of Tiotropium Inhalation Solution Delivered Via Respimat® Inhaler (2.5 ug and 5 ug Once Daily) Compared to Placebo Over 12 Weeks in Mild Persistent Asthma

TypeinterventionalSponsorBoehringer IngelheimRan2011 to 2012Enrolled465ConditionsAsthmaArmsplacebo, tiotropium 2.5 mcg, tiotropium 5 mcg
NCT01340209 phase3completednot on this map

A Phase III Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate Safety and Efficacy of Tiotropium Inhalation Solution Delivered Via Respimat Inhaler (2.5 and 5 µg Once Daily) Compared With Placebo Over 52 Weeks in Patients With Moderate to Severe Persistent Asthma

TypeinterventionalSponsorBoehringer IngelheimRan2011 to 2013Enrolled285ConditionsAsthmaArmsTiotropium Respimat, Placebo Respimat
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 25 citations in OpenAlex.

  1. Article
  2. Article
  3. Observational
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Agreement between forced expiratory volume in the first second (FEVLung India : official organ of Indian Chest Society
    Article
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

8 authors at 5 institutions in 4 countries.

David M G HalpinUniversity of Exeter Medical School, College of Medicine and Health, University of Exeter, Exeter, EX1 2LU, UK. d.halpin@nhs.net.
Eli O MeltzerAllergy and Asthma Medical Group and Research Center, University of California, San Diego, CA, USA.
Wendelgard Pisternick-RufBoehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany.
Petra Moroni-ZentgrafBoehringer Ingelheim Pty Ltd, Sydney, Australia.
Michael EngelBoehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.
Liliana Zaremba-PechmannBoehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany.
Thomas CasaleDivision of Allergy and Immunology, University of South Florida Morsani College of Medicine, Tampa, FL, USA.
J Mark FitzGeraldCentre for Heart and Lung Health, Vancouver, Canada.
Boehringer Ingelheim (Germany) · DEBoehringer Ingelheim (Australia) · AUUniversity of California, San Diego · USUniversity of Exeter · GBUniversity of South Florida · US

Funding

Boehringer Ingelheim N/A
6 · The paper itself

Abstract

backgroundThe primary lung function endpoint in clinical trials in adolescent and adult patients with asthma is usually forced expiratory volume in one second (FEV

methodsFor this assessment, we calculated post hoc the correlation between pre-dose FEV

resultsAcross all 8 trials included in this analysis, changes in lung function from baseline correlated well between pre-dose FEV

conclusionsPre-dose PEF measured at home could be an alternative primary lung function endpoint for trials in adolescent and adult patients with asthma. Using home-measured PEF could facilitate trial conduct and improve the convenience for patients by relocating scheduled assessments from the clinic to the patient's home.

trial registrationAdolescents aged 12 to 17 years: RubaTinA-asthma® ( NCT01257230 ), PensieTinA-asthma® ( NCT01277523 ). Adults aged 18 to 75 years: GraziaTinA-asthma® ( NCT01316380 ), MezzoTinA-asthma® ( NCT01172808 / NCT01172821 ), CadenTinA-asthma® ( NCT01340209 ), PrimoTinA-asthma® ( NCT00772538 / NCT00776984 ). All from Clinicaltrials.gov ( https://clinicaltrials.gov/ ).

Indexed as

AdolescentAdultAgedAsthmaChildClinical Trials, Phase III as TopicFemaleForced Expiratory VolumeHumansMaleMiddle AgedPeak Expiratory Flow RateRespiratory Function TestsYoung AdultAsthmaCorrelationFEV1Home-measurementIn-clinic measurementPEFTiotropium

Identifiers

PMID31319851
PMCPMC6637596
OpenAlexW2959105853

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

and 2 more above

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.