Effect of Symbicort on GR Localisation in Asthma

Summary

To investigate a possible interaction between formoterol and budesonide on GR-translocation and to compare the effect of different doses of Symbicort (80/4.5 and 2x80/4.5 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.

Timeline

Start

2004-11

Primary completion

2006-11

Completion

2006-11

Outcome

Met primary endpoint

registry Placebo vs Budesonide/Formoterol Combination Single; p = 0.04; ANOVA NCT00159263 ↗

registry Placebo vs Budesonide/Formoterol Combination Double; p = 0.01; ANOVA NCT00159263 ↗

registry Placebo vs Budesonide/Formoterol Combination Double; p = 0.04; ANOVA NCT00159263 ↗

Publications

• Results Essilfie-Quaye S, Ito K, Ito M, Kharitonov SA, Barnes PJ. Comparison of Symbicort(R) versus Pulmicort(R) on steroid pharmacodynamic markers in asthma patients. Respir Med. 2011 Dec;105(12):1784-9. doi: 10.1016/j.rmed.2011.08.020. Epub 2011 Sep 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Budesonide	Small molecule	100 ug	Inhaled
Subject	Budesonide	Small molecule	200 ug	Inhaled
Subject	Budesonide	Small molecule	800 ug	Inhaled
Subject	Formoterol	Other / unclassified	6 ug	Inhaled
Subject	Formoterol	Other / unclassified	12 ug	Inhaled

Indications