Evidence map›Paper›PMID 27130202›Full record

Trial reportBMC pulmonary medicine2016

Efficacy and safety of ipratropium bromide/albuterol compared with albuterol in patients with moderate-to-severe asthma: a randomized controlled trial.

James F Donohue, Robert Wise, William W Busse, Sandra Garfinkel, Valentina B Zubek, Mo Ghafouri, Raymond C Manuel, Rozsa Schlenker-Herceg, Eugene R Bleecker

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC pulmonary medicine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00818454 (A Multicenter Randomized Study Starting With a 4 Week 2 Way Crossover Double Blind Treatment Phase Comparing the Efficacy and Safety of Combivent CFC MDI to Albuterol HFA MDI Followed by a 4 Week Open Label Combivent Respimat Treatment Phase When All Study Drugs Are Used for Symptom Relief as Needed in Pts With Moderate to Severe Asthma), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.8field-weighted citation impact, top 16% 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.

NCT00818454 phase2completednot on this map

A Multicenter Randomized Study Starting With a 4 Week 2 Way Crossover Double Blind Treatment Phase Comparing the Efficacy and Safety of Combivent CFC MDI to Albuterol HFA MDI Followed by a 4 Week Open Label Combivent Respimat Treatment Phase When All Study Drugs Are Used for Symptom Relief as Needed in Pts With Moderate to Severe Asthma (GINA 2007 Treatment Steps 3-5)

TypeinterventionalSponsorBoehringer IngelheimRan2008Enrolled226ConditionsAsthmaArmsCombivent CFC MDI, Albuterol HFA MDI, Respimat Combivent
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 20 citations in OpenAlex.

  1. Patterns of bronchodilator therapy in asthmatic outpatients.Journal of public health in Africa · 2023
    Article
  2. Review
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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

9 authors at 6 institutions in 2 countries.

James F DonohueDivision of Pulmonary Diseases & Critical Care Medicine, University of North Carolina, Chapel Hill, NC, USA.
Robert WisePulmonary and Critical Care Division, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
William W BusseDepartment of Medicine, University of Wisconsin, Wisconsin, WI, USA.
Sandra GarfinkelBoehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.
Valentina B ZubekBoehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.
Mo GhafouriBoehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.
Raymond C ManuelBoehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.
Rozsa Schlenker-HercegBoehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.
Eugene R BleeckerWake Forest School of Medicine, Center for Genomics and Personalized Medicine, Winston-Salem, NC, 27157, USA. ebleeck@wakehealth.edu.
Boehringer Ingelheim (United States) · USBoehringer Ingelheim (France) · FRJohns Hopkins Medicine · USUniversity of North Carolina at Chapel Hill · USUniversity of Wisconsin–Madison · USWake Forest University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMany patients with asthma require frequent rescue medication for acute symptoms despite appropriate controller therapies. Thus, determining the most effective relief regimen is important in the management of more severe asthma. This study's objective was to evaluate whether ipratropium bromide/albuterol metered-dose inhaler (CVT-MDI) provides more effective acute relief of bronchospasm in moderate-to-severe asthma than albuterol hydrofluoroalkaline (ALB-HFA) alone after 4 weeks.

methodsIn this double-blind, crossover study, patients who had been diagnosed with asthma for ≥1 year were randomized to two sequences of study medication "as needed" for symptom relief (1-7 day washout before second 4-week treatment period): CVT-MDI/ALB-HFA or ALB-HFA/CVT-MDI. On days 1 and 29 of each sequence, 6-hour serial spirometry was performed after administration of the study drug. Co-primary endpoints were FEV1 area under the curve (AUC0-6) and peak (post-dose) forced expiratory volume in 1 s (FEV1) response (change from test day baseline) after 4 weeks. The effects of "as needed" treatment with ALB-HFA/CVT-MDI were analyzed using mixed effect model repeated measures (MMRM).

resultsA total of 226 patients, ≥18 years old, with inadequately controlled, moderate-to-severe asthma were randomized. The study met both co-primary endpoints demonstrating a statistically significant treatment benefit of CVT-MDI versus ALB-HFA. FEV1 AUC0-6h response was 167 ml for ALB-HFA, 252 ml for CVT-MDI (p <0.0001); peak FEV1 response was 357 ml for ALB-HFA, 434 ml for CVT-MDI (p <0.0001). Adverse events were comparable across groups.

conclusionsCVT-MDI significantly improved acute bronchodilation over ALB-HFA alone after 4 weeks of "as-needed" use for symptom relief, with a similar safety profile. This suggests additive bronchodilator effects of β2-agonist and anticholinergic treatment in moderate-to-severe, symptomatic asthma.

trial registrationClinicalTrials.gov No.: NCT00818454 ; Registered November 16, 2009.

Indexed as

Administration, InhalationAdrenergic beta-2 Receptor AgonistsAlbuterolAsthmaBronchodilator AgentsCross-Over StudiesDose-Response Relationship, DrugDouble-Blind MethodDrug Therapy, CombinationFemaleFollow-Up StudiesForced Expiratory VolumeHumansIpratropiumMaleMetered Dose InhalersAdrenergic beta-2 Receptor AgonistsAlbuterolBronchodilator AgentsIpratropiumAcute symptom reliefAlbuterol hydrofluoroalkalineAnticholinergic/β2-agonistAs-neededBronchodilationIpratropium bromideIpratropium bromide/albuterol metered-dose inhalerModerate-to-severe asthmaRandomized controlled trial

Identifiers

PMID27130202
PMCPMC4851785
OpenAlexW2344999173

What OpenQuestion holds

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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.