Asthma
Conditions
Keywords
asthma, adults, adolescents, safety, Symbicort, budesonide/formoterol, budesonide
Brief summary
The purpose of this study is to compare the long term safety of Symbicort with budesonide alone, in adolescents and adults with asthma.
Interventions
DRUGbudesonide/formoterol
DRUGSymbicort pMDI + budesonide HFA pMDI
Symbicort 2 X 160/4.5mcg & budesonide HFA pMDI 4 X 160mcg
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of asthma and baseline lung function tests, symptoms and medication use as determined by the protocol * Required and received treatment with inhaled corticosteroids within the timeframe and doses specified in the protocol
Exclusion criteria
* Has required treatment with non-inhaled corticosteroids within previous 30 days, has sensitivity to drugs specified in the protocol or requires treatment with a beta-blocker. * Has had cancer within previous 5 years or has a condition that may put the patient at risk in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Asthma exacerbations, ECG and Holter monitors, lung function, adverse events, requirement of other asthma therapies and other routine safety assessments. | 7 assessments within 12 month treatment period |
Secondary
| Measure | Time frame |
|---|---|
| To measure changes in lung function tests, patient reported outcomes and usage of medical resource | 7 assessments within 12 month treatment period |
| Blood levels of budesonide and formoterol | 10 blood samples taken at 1 visit in a sub-set of patients |
Outcome results
None listed