Exposure-Response and Clinical Outcome Modeling of Inhaled Budesonide/Formoterol Combination in Asthma Patients.
asthma control test
budesonide/formoterol
dose optimization
moderate asthma
population analysis
Journal
Pharmaceutics
ISSN: 1999-4923
Titre abrégé: Pharmaceutics
Pays: Switzerland
ID NLM: 101534003
Informations de publication
Date de publication:
09 Apr 2020
09 Apr 2020
Historique:
received:
13
03
2020
revised:
06
04
2020
accepted:
07
04
2020
entrez:
15
4
2020
pubmed:
15
4
2020
medline:
15
4
2020
Statut:
epublish
Résumé
Exposure-response and clinical outcome (CO) model for inhaled budesonide/formoterol was developed to quantify the relationship among pharmacokinetics (PK), pharmacodynamics (PD) and CO of the drugs and evaluate the covariate effect on model parameters. Sputum eosinophils cationic proteins (ECP) and forced expiratory volume (FEV1) were selected as PD markers and asthma control score was used as a clinical outcome. One- and two-compartment models were used to describe the PK of budesonide and formoterol, respectively. The indirect response model (IDR) was used to describe the PD effect for ECP and FEV1. In addition, the symptomatic effect on the disease progression model for CO was connected with IDR on each PD response. The slope for the effect of ECP and FEV1 to disease progression were estimated as 0.00008 and 0.644, respectively. Total five covariates (ex. ADRB2 genotype etc.) were searched using a stepwise covariate modeling method, however, there was no significant covariate effect. The results from the simulation study were showed that a 1 puff b.i.d. had a comparable effect of asthma control with a 2 puff b.i.d. As a result, the 1 puff b.i.d. of combination drug could be suggested as a standardized dose to minimize the side effects and obtain desired control of disease compared to the 2 puff b.i.d.
Identifiants
pubmed: 32283726
pii: pharmaceutics12040336
doi: 10.3390/pharmaceutics12040336
pmc: PMC7238265
pii:
doi:
Types de publication
Journal Article
Langues
eng
Subventions
Organisme : Korea Health Industry Development Institute
ID : HI17C0970
Pays : Republic of Korea
Organisme : Korea Health Industry Development Institute
ID : HI16C0992
Pays : Republic of Korea
Déclaration de conflit d'intérêts
The authors declare no conflict of interest.
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