Pharmacokinetics and pharmacodynamics of albuterol multidose dry powder inhaler and albuterol hydrofluoroalkane in children with asthma. Ratnayake A., Taveras H., Iverson H., & Shore P. 2016. ![Pharmacokinetics and pharmacodynamics of albuterol multidose dry powder inhaler and albuterol hydrofluoroalkane in children with asthma [link]](https://bibbase.org/img/filetypes/link.svg "link")
Paper abstract bibtex Background: Many children struggle with the use of albuterol hydrofluoroalkane (HFA) inhalers. Albuterol multidose dry powder inhaler (MDPI) may simplify rescue bronchodilator use in children. Objective: To compare the pharmacokinetics (PK), pharmacodynamics (PD), and tolerability of albuterol MDPI and albuterol HFA after a single inhaled dose in children with asthma. Methods: This single-center, open-label, two-period crossover study randomized children to albuterol MDPI or HFA 180 mug on two treatment days with a 4- to 14-day washout. Plasma albuterol concentrations were measured before the dose and up to 10 hours after the dose to determine the primary PK values of area under the plasma concentration-versus-time curve from time 0 to the last measurable concentration (AUC0-t), maximum observed concentration (Cmax), and AUC from time 0 extrapolated to infinity (AUC0-inf). Heart rate and blood pressure before the dose and after the dose were monitored for PD effects, and adverse events (AE) were monitored for overall safety. Results: Fifteen children, ages 6-11 years, were included (PK, n = 13 for time to Cmax and terminal half-life of elimination; n = 12 for AUC and Cmax due to incomplete data). AUC0-t (geometric mean ratio [GMR] 1.056 [90% confidence interval \CI\, 0.88 -1.268]) and AUC0-inf (GMR 0.971 [90% CI, 0.821-1.147]) were comparable between treatments. Cmax was larger for albuterol MDPI versus HFA (GMR 1.340 [90% CI, 1.098 -1.636]). PD parameters between the treatments were comparable. No deaths, serious AEs, treatment-emergent AEs, or withdrawals due to AEs were reported for either treatment. Conclusion: Albuterol MDPI and albuterol HFA had comparable PK and PD in children after a single 180-mug dose. Copyright ©2016, OceanSide Publications, Inc., U.S.A.
@misc{ratnayake_a._pharmacokinetics_2016,
title = {Pharmacokinetics and pharmacodynamics of albuterol multidose dry powder inhaler and albuterol hydrofluoroalkane in children with asthma},
url = {http://www.ingentaconnect.com/search/download?pub=infobike%3a%2f%2focean%2faap%2f2016%2f00000037%2f00000005%2fart00011&mimetype=application%2fpdf&exitTargetId=1473325081442},
abstract = {Background: Many children struggle with the use of albuterol hydrofluoroalkane (HFA) inhalers. Albuterol multidose dry powder inhaler (MDPI) may simplify rescue bronchodilator use in children. Objective: To compare the pharmacokinetics (PK), pharmacodynamics (PD), and tolerability of albuterol MDPI and albuterol HFA after a single inhaled dose in children with asthma. Methods: This single-center, open-label, two-period crossover study randomized children to albuterol MDPI or HFA 180 mug on two treatment days with a 4- to 14-day washout. Plasma albuterol concentrations were measured before the dose and up to 10 hours after the dose to determine the primary PK values of area under the plasma concentration-versus-time curve from time 0 to the last measurable concentration (AUC0-t), maximum observed concentration (Cmax), and AUC from time 0 extrapolated to infinity (AUC0-inf). Heart rate and blood pressure before the dose and after the dose were monitored for PD effects, and adverse events (AE) were monitored for overall safety. Results: Fifteen children, ages 6-11 years, were included (PK, n = 13 for time to Cmax and terminal half-life of elimination; n = 12 for AUC and Cmax due to incomplete data). AUC0-t (geometric mean ratio [GMR] 1.056 [90\% confidence interval \{CI\}, 0.88 -1.268]) and AUC0-inf (GMR 0.971 [90\% CI, 0.821-1.147]) were comparable between treatments. Cmax was larger for albuterol MDPI versus HFA (GMR 1.340 [90\% CI, 1.098 -1.636]). PD parameters between the treatments were comparable. No deaths, serious AEs, treatment-emergent AEs, or withdrawals due to AEs were reported for either treatment. Conclusion: Albuterol MDPI and albuterol HFA had comparable PK and PD in children after a single 180-mug dose. Copyright ©2016, OceanSide Publications, Inc., U.S.A.},
journal = {Allergy and Asthma Proceedings},
author = {{Ratnayake A.} and {Taveras H.} and {Iverson H.} and {Shore P.}},
year = {2016},
keywords = {*albuterol hydrofluoroalkane/ae [Adverse Drug Reaction], *albuterol hydrofluoroalkane/cm [Drug Comparison], *albuterol hydrofluoroalkane/ct [Clinical Trial], *albuterol hydrofluoroalkane/dt [Drug Therapy], *albuterol hydrofluoroalkane/ih [Inhalational Drug Administration], *albuterol hydrofluoroalkane/pk [Pharmacokinetics], *antiasthmatic agent/ae [Adverse Drug Reaction], *antiasthmatic agent/cm [Drug Comparison], *antiasthmatic agent/ct [Clinical Trial], *antiasthmatic agent/dt [Drug Therapy], *antiasthmatic agent/ih [Inhalational Drug Administration], *antiasthmatic agent/pk [Pharmacokinetics], *asthma, *asthma/dt [Drug Therapy], *dry powder inhaler, *dry powder inhaler/ct [Clinical Trial], *dry powder inhaler/dc [Device Comparison], *inhaler, *inhaler/ct [Clinical Trial], *inhaler/dc [Device Comparison], *multidose dry powder inhaler, *multidose dry powder inhaler/ct [Clinical Trial], *multidose dry powder inhaler/dc [Device Comparison], *pharmacodynamics, *salbutamol, *salbutamol/ae [Adverse Drug Reaction], *salbutamol/cm [Drug Comparison], *salbutamol/cr [Drug Concentration], *salbutamol/ct [Clinical Trial], *salbutamol/dt [Drug Therapy], *salbutamol/ih [Inhalational Drug Administration], *salbutamol/pk [Pharmacokinetics], Child, Pharmacokinetics, adverse drug reaction, area under the curve, asthma/dt [Drug Therapy], blood pressure, blood pressure monitoring, clinical article, clinical trial, conference paper, confidence interval, controlled clinical trial, controlled study, crossover procedure, death, drug blood level, drug efficacy, drug elimination, drug half life, drug monitoring, drug safety, drug withdrawal, female, fluorinated hydrocarbon, half life time, heart rate, human, human tissue, male, maximum plasma concentration, pharmacodynamics, phase 1 clinical trial, plasma concentration-time curve, preschool child, randomized controlled trial, safety, side effect, time to maximum plasma concentration, unclassified drug, unspecified side effect/si [Side Effect]}
}
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{"_id":"2tzNE7Yv6WaxdayPL","bibbaseid":"ratnayakea-taverash-iversonh-shorep-pharmacokineticsandpharmacodynamicsofalbuterolmultidosedrypowderinhalerandalbuterolhydrofluoroalkaneinchildrenwithasthma-2016","downloads":0,"creationDate":"2017-05-12T20:20:58.169Z","title":"Pharmacokinetics and pharmacodynamics of albuterol multidose dry powder inhaler and albuterol hydrofluoroalkane in children with asthma","author_short":["Ratnayake A.","Taveras H.","Iverson H.","Shore P."],"year":2016,"bibtype":"misc","biburl":"http://bibbase.org/zotero/gxu917","bibdata":{"bibtype":"misc","type":"misc","title":"Pharmacokinetics and pharmacodynamics of albuterol multidose dry powder inhaler and albuterol hydrofluoroalkane in children with asthma","url":"http://www.ingentaconnect.com/search/download?pub=infobike%3a%2f%2focean%2faap%2f2016%2f00000037%2f00000005%2fart00011&mimetype=application%2fpdf&exitTargetId=1473325081442","abstract":"Background: Many children struggle with the use of albuterol hydrofluoroalkane (HFA) inhalers. Albuterol multidose dry powder inhaler (MDPI) may simplify rescue bronchodilator use in children. Objective: To compare the pharmacokinetics (PK), pharmacodynamics (PD), and tolerability of albuterol MDPI and albuterol HFA after a single inhaled dose in children with asthma. Methods: This single-center, open-label, two-period crossover study randomized children to albuterol MDPI or HFA 180 mug on two treatment days with a 4- to 14-day washout. Plasma albuterol concentrations were measured before the dose and up to 10 hours after the dose to determine the primary PK values of area under the plasma concentration-versus-time curve from time 0 to the last measurable concentration (AUC0-t), maximum observed concentration (Cmax), and AUC from time 0 extrapolated to infinity (AUC0-inf). Heart rate and blood pressure before the dose and after the dose were monitored for PD effects, and adverse events (AE) were monitored for overall safety. Results: Fifteen children, ages 6-11 years, were included (PK, n = 13 for time to Cmax and terminal half-life of elimination; n = 12 for AUC and Cmax due to incomplete data). AUC0-t (geometric mean ratio [GMR] 1.056 [90% confidence interval \\CI\\, 0.88 -1.268]) and AUC0-inf (GMR 0.971 [90% CI, 0.821-1.147]) were comparable between treatments. Cmax was larger for albuterol MDPI versus HFA (GMR 1.340 [90% CI, 1.098 -1.636]). PD parameters between the treatments were comparable. No deaths, serious AEs, treatment-emergent AEs, or withdrawals due to AEs were reported for either treatment. Conclusion: Albuterol MDPI and albuterol HFA had comparable PK and PD in children after a single 180-mug dose. Copyright ©2016, OceanSide Publications, Inc., U.S.A.","journal":"Allergy and Asthma Proceedings","author":[{"firstnames":[],"propositions":[],"lastnames":["Ratnayake A."],"suffixes":[]},{"firstnames":[],"propositions":[],"lastnames":["Taveras H."],"suffixes":[]},{"firstnames":[],"propositions":[],"lastnames":["Iverson H."],"suffixes":[]},{"firstnames":[],"propositions":[],"lastnames":["Shore P."],"suffixes":[]}],"year":"2016","keywords":"*albuterol hydrofluoroalkane/ae [Adverse Drug Reaction], *albuterol hydrofluoroalkane/cm [Drug Comparison], *albuterol hydrofluoroalkane/ct [Clinical Trial], *albuterol hydrofluoroalkane/dt [Drug Therapy], *albuterol hydrofluoroalkane/ih [Inhalational Drug Administration], *albuterol hydrofluoroalkane/pk [Pharmacokinetics], *antiasthmatic agent/ae [Adverse Drug Reaction], *antiasthmatic agent/cm [Drug Comparison], *antiasthmatic agent/ct [Clinical Trial], *antiasthmatic agent/dt [Drug Therapy], *antiasthmatic agent/ih [Inhalational Drug Administration], *antiasthmatic agent/pk [Pharmacokinetics], *asthma, *asthma/dt [Drug Therapy], *dry powder inhaler, *dry powder inhaler/ct [Clinical Trial], *dry powder inhaler/dc [Device Comparison], *inhaler, *inhaler/ct [Clinical Trial], *inhaler/dc [Device Comparison], *multidose dry powder inhaler, *multidose dry powder inhaler/ct [Clinical Trial], *multidose dry powder inhaler/dc [Device Comparison], *pharmacodynamics, *salbutamol, *salbutamol/ae [Adverse Drug Reaction], *salbutamol/cm [Drug Comparison], *salbutamol/cr [Drug Concentration], *salbutamol/ct [Clinical Trial], *salbutamol/dt [Drug Therapy], *salbutamol/ih [Inhalational Drug Administration], *salbutamol/pk [Pharmacokinetics], Child, Pharmacokinetics, adverse drug reaction, area under the curve, asthma/dt [Drug Therapy], blood pressure, blood pressure monitoring, clinical article, clinical trial, conference paper, confidence interval, controlled clinical trial, controlled study, crossover procedure, death, drug blood level, drug efficacy, drug elimination, drug half life, drug monitoring, drug safety, drug withdrawal, female, fluorinated hydrocarbon, half life time, heart rate, human, human tissue, male, maximum plasma concentration, pharmacodynamics, phase 1 clinical trial, plasma concentration-time curve, preschool child, randomized controlled trial, safety, side effect, time to maximum plasma concentration, unclassified drug, unspecified side effect/si [Side Effect]","bibtex":"@misc{ratnayake_a._pharmacokinetics_2016,\n\ttitle = {Pharmacokinetics and pharmacodynamics of albuterol multidose dry powder inhaler and albuterol hydrofluoroalkane in children with asthma},\n\turl = {http://www.ingentaconnect.com/search/download?pub=infobike%3a%2f%2focean%2faap%2f2016%2f00000037%2f00000005%2fart00011&mimetype=application%2fpdf&exitTargetId=1473325081442},\n\tabstract = {Background: Many children struggle with the use of albuterol hydrofluoroalkane (HFA) inhalers. Albuterol multidose dry powder inhaler (MDPI) may simplify rescue bronchodilator use in children. Objective: To compare the pharmacokinetics (PK), pharmacodynamics (PD), and tolerability of albuterol MDPI and albuterol HFA after a single inhaled dose in children with asthma. Methods: This single-center, open-label, two-period crossover study randomized children to albuterol MDPI or HFA 180 mug on two treatment days with a 4- to 14-day washout. Plasma albuterol concentrations were measured before the dose and up to 10 hours after the dose to determine the primary PK values of area under the plasma concentration-versus-time curve from time 0 to the last measurable concentration (AUC0-t), maximum observed concentration (Cmax), and AUC from time 0 extrapolated to infinity (AUC0-inf). Heart rate and blood pressure before the dose and after the dose were monitored for PD effects, and adverse events (AE) were monitored for overall safety. Results: Fifteen children, ages 6-11 years, were included (PK, n = 13 for time to Cmax and terminal half-life of elimination; n = 12 for AUC and Cmax due to incomplete data). AUC0-t (geometric mean ratio [GMR] 1.056 [90\\% confidence interval \\{CI\\}, 0.88 -1.268]) and AUC0-inf (GMR 0.971 [90\\% CI, 0.821-1.147]) were comparable between treatments. Cmax was larger for albuterol MDPI versus HFA (GMR 1.340 [90\\% CI, 1.098 -1.636]). PD parameters between the treatments were comparable. No deaths, serious AEs, treatment-emergent AEs, or withdrawals due to AEs were reported for either treatment. Conclusion: Albuterol MDPI and albuterol HFA had comparable PK and PD in children after a single 180-mug dose. Copyright ©2016, OceanSide Publications, Inc., U.S.A.},\n\tjournal = {Allergy and Asthma Proceedings},\n\tauthor = {{Ratnayake A.} and {Taveras H.} and {Iverson H.} and {Shore P.}},\n\tyear = {2016},\n\tkeywords = {*albuterol hydrofluoroalkane/ae [Adverse Drug Reaction], *albuterol hydrofluoroalkane/cm [Drug Comparison], *albuterol hydrofluoroalkane/ct [Clinical Trial], *albuterol hydrofluoroalkane/dt [Drug Therapy], *albuterol hydrofluoroalkane/ih [Inhalational Drug Administration], *albuterol hydrofluoroalkane/pk [Pharmacokinetics], *antiasthmatic agent/ae [Adverse Drug Reaction], *antiasthmatic agent/cm [Drug Comparison], *antiasthmatic agent/ct [Clinical Trial], *antiasthmatic agent/dt [Drug Therapy], *antiasthmatic agent/ih [Inhalational Drug Administration], *antiasthmatic agent/pk [Pharmacokinetics], *asthma, *asthma/dt [Drug Therapy], *dry powder inhaler, *dry powder inhaler/ct [Clinical Trial], *dry powder inhaler/dc [Device Comparison], *inhaler, *inhaler/ct [Clinical Trial], 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