Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00159263
Status:
COMPLETED
Last Update Posted:
2019-09-27
First Post:
2005-09-08
Brief Title:
Effect of Symbicort on GR Localisation in Asthma
Sponsor:
Imperial College London
Organization:
Imperial College London
Study Overview
Official Title:
Effect of Symbicort on GR Glucocorticoid Receptor Translocation in Induced Sputum in Comparison With Budesonide Formoterol and Placebo A Single Dose Exploratory Study in Patients With Mild Asthma
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To investigate a possible interaction between formoterol and budesonide on GR-translocation and to compare the effect of different doses of Symbicort 8045 and 2x8045 mcg with the effect of budesonide 200 mcg and 800 mcg on GR translocation and to investigate the effect of the study drugs on exhaled NO bronchial and alveolar fraction
Detailed Description:
Combination therapy with inhaled corticosteroids ICS and long-acting β2-adrenergic agonists LABA is reported to have superior effects on controlling asthma symptoms to ICS alone however there is no molecular-based evidence to explain the clinical effects Here the effect of the ICSLABA combination was compared with ICS on glucocorticoid receptor GR activation in sputum macrophage
In a randomised double-blind cross-over placebo-controlled 6-visit study 10 patients with mild asthma were given placebo formoterol Oxis 12 μg budesonide Pulmicort 200 μg BUD200 or 800 μg BUD800 or budesonideformoterol combination Symbicort as a single 1006 μg SYM100 or double 20012 μg SYM200 dose Sputum macrophages were separated by plate adhesion from induced sputum GR binding to the glucocorticoid-response elements on oligonucleotides GR-GRE binding was evaluated by ELISA mRNA expression of MAP-kinase phosphatase MKP-1 and IL-8 were measured by quantitative RT-PCR
In a randomised double-blind cross-over placebo-controlled 6-visit study 10 patients with mild asthma were given placebo formoterol Oxis 12 μg budesonide Pulmicort 200 μg BUD200 or 800 μg BUD800 or budesonideformoterol combination Symbicort as a single 1006 μg SYM100 or double 20012 μg SYM200 dose Sputum macrophages were separated by plate adhesion from induced sputum GR binding to the glucocorticoid-response elements on oligonucleotides GR-GRE binding was evaluated by ELISA mRNA expression of MAP-kinase phosphatase MKP-1 and IL-8 were measured by quantitative RT-PCR
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None