Trial reportEuropean journal of drug metabolism and pharmacokinetics2017
Population Pharmacokinetics Modeling of Inhaled Umeclidinium for Adult Patients with Asthma.
Trial report in European journal of drug metabolism and pharmacokinetics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01641692 (A Multi-national, Randomized, Double-blind, Placebo-controlled, 3-period Crossover Study With GSK 573719 as Monotherapy in Adult Subjects With Asthma), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.
What it found
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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 Multi-national, Randomized, Double-blind, Placebo-controlled, 3-period Crossover Study With GSK 573719 as Monotherapy in Adult Subjects With Asthma
Who cites it
2 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.
- Assessment of the predictive capability of modelling and simulation to determine bioequivalence of inhaled drugs: A systematic review.Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences · 2022Pooled it
- Population Pharmacokinetic Modeling of Fluticasone Furoate, Umeclidinium Bromide, and Vilanterol in Patients with Asthma, Using Data from a Phase IIIA Study (CAPTAIN).Clinical pharmacokinetics · 2021Trial
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundUmeclidinium (UMEC; a long-acting anti-muscarinic) in combination with fluticasone furoate (an inhaled corticosteroid) is in development for asthma treatment. This secondary analysis aimed to develop a population pharmacokinetic model characterizing UMEC in adults with asthma, and evaluated the impact of covariates on pharmacokinetic parameters.
methodsPlasma concentration data from study NCT01641692 (assessing once-daily UMEC 15.6, 31.25, 62.5, 125, and 250 mcg, twice daily UMEC 15.6 and 31.25 mcg, and placebo) were analyzed using non-linear mixed-effect modeling in NONMEM
resultsIn total, 128 patients provided 3757 data points. The pharmacokinetics of UMEC were best described using a two-compartment model with intravenous bolus input, due to fast absorption following inhalation. CL/F was 257 L/h and V
conclusionThe final population pharmacokinetic model adequately described the data, demonstrating minimal creatinine clearance, age, and body weight effects on overall plasma UMEC pharmacokinetics and systemic exposure.
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Registered trials
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