A 4-week, open-label, randomized, multi-centre, parallel-group study evaluating the safety and efficacy of 4 actuations symbicort (budesonide/formoterol) HFA pMDI [hydrofluoroalkane pressurised metered-dose inhaler] 40/2.25 microg twice daily, with and without spacer, in children (6-11 years) with asthma.
Phase of Trial: Phase III
Latest Information Update: 05 Apr 2012
At a glance
- Drugs Budesonide/formoterol (Primary)
- Indications Asthma
- Focus Adverse reactions
- Sponsors AstraZeneca
- 31 Aug 2018 Biomarkers information updated
- 15 Mar 2012 Actual initiation data changed from Sep 2007 to 15 Aug 2007 as reported by European Clinical Trials Database.
- 04 Jun 2008 Astrazeneca submitted sNDA to FDA for the long-term maintenace of asthma in children 6-11 years of age.