Trial reportPloS one2012
Safety, tolerability, pharmacodynamics and pharmacokinetics of umeclidinium and vilanterol alone and in combination: a randomized crossover trial.
Trial report in PloS one, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00976144 (A Single Centre, Randomised, Placebo-controlled, Four-way Cross Over Study to Assess the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single Inhaled Doses of GSK573719 and GW642444 as Monotherapies and Concurrently in Healthy Japanese Subjects), which is not on this map. Cited by 21 papers, 4 of them syntheses that pooled 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.
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.
A Single Centre, Randomised, Placebo-controlled, Four-way Cross Over Study to Assess the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single Inhaled Doses of GSK573719 and GW642444 as Monotherapies and Concurrently in Healthy Japanese Subjects
Who cites it
21 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- Umeclidinium bromide versus placebo for people with chronic obstructive pulmonary disease (COPD).The Cochrane database of systematic reviews · 2017Pooled it
- Pooled it
- Pooled it
- Comparative efficacy of combination bronchodilator therapies in COPD: a network meta-analysis.International journal of chronic obstructive pulmonary disease · 2015Pooled it
- Population Pharmacokinetics Modeling of Inhaled Umeclidinium for Adult Patients with Asthma.European journal of drug metabolism and pharmacokinetics · 2017Trial
- Trial
- Effect of verapamil on systemic exposure and safety of umeclidinium and vilanterol: a randomized and open-label study.International journal of chronic obstructive pulmonary disease · 2013Trial
- Evidence-based review of data on the combination inhaler umeclidinium/vilanterol in patients with COPD.International journal of chronic obstructive pulmonary disease · 2019Review
- Umeclidinium in chronic obstructive pulmonary disease: latest evidence and place in therapy.Therapeutic advances in chronic disease · 2017Review
- Spotlight on fluticasone furoate/umeclidinium/vilanterol in COPD: design, development, and potential place in therapy.International journal of chronic obstructive pulmonary disease · 2017Review
- The ELLIPTA® Dry Powder Inhaler: Design, Functionality, In Vitro Dosing Performance and Critical Task Compliance by Patients and Caregivers.Journal of aerosol medicine and pulmonary drug delivery · 2015Article
- Review
- Effect of severe renal impairment on umeclidinium and umeclidinium/vilanterol pharmacokinetics and safety: a single-blind, nonrandomized study.International journal of chronic obstructive pulmonary disease · 2015Article
- Patient considerations in the treatment of COPD: focus on the new combination inhaler umeclidinium/vilanterol.Patient preference and adherence · 2015Review
- Umeclidinium bromide and vilanterol trifenatate inhalation powder.Hospital pharmacy · 2014Article
- Umeclidinium/Vilanterol: first global approval.Drugs · 2014Article
- Differential pharmacology and clinical utility of emerging combination treatments in the management of COPD--role of umeclidinium/vilanterol.International journal of chronic obstructive pulmonary disease · 2014Review
- Profile of fluticasone furoate/vilanterol dry powder inhaler combination therapy as a potential treatment for COPD.International journal of chronic obstructive pulmonary disease · 2014Review
- Autism traits in the RASopathies.Journal of medical genetics · 2014Article
- New developments in the combination treatment of COPD: focus on umeclidinium/vilanterol.Drug design, development and therapy · 2013Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
unlabelledUmeclidinium bromide (GSK573719; UMEC), a new long-acting muscarinic receptor antagonist (LAMA), is in development with vilanterol (GW642444; VI), a selective long-acting β(2) agonist (LABA), as a once-daily inhaled combination therapy for the treatment of chronic obstructive pulmonary disease (COPD). A single dose healthy volunteer study was conducted to assess the safety and tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of inhaled umeclidinium (500 µg) and vilanterol (50 µg) when administered separately and in combination using a novel dry powder inhaler (NDPI). Co-administration of single inhaled doses of umeclidinium and vilanterol to healthy Japanese subjects was well tolerated and not associated with meaningful changes in systemic exposure or PD effects compared with administration of either compound individually. Pharmacokinetic assessments showed rapid absorption for both drugs (Tmax = 5 min for both umeclidinium and vilanterol) followed by rapid elimination with median tlast of 4-5 h for umeclidinium and median tlast of 1.5-2.0 h for vilanterol. Assessments of pharmacokinetic interaction were inconclusive since for umeclidinium, Cmax following combination was higher than umeclidinium alone but not AUC whereas for vilanterol, AUC following combination was higher than vilanterol alone but not Cmax. There were no obvious trends observed between individual maximum supine heart rate and umeclidinium Cmax or vilanterol Cmax when delivered as umeclidinium 500 µg and vilanterol 50 µg combination or when delivered as umeclidinium or vilanterol alone.
trial registrationClinicaltrials.gov NCT00976144.
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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.