NCT00646516CompletedPhase 3
A Rand, Doubleblind, Activecontrolled, Parallel-grp,Singledummy, Multicenter,12 wk Study to Assess the Effic.&Safety of Symbicort pMDI 2x160/4.5mcg QD Compared to Symb. pMDI 2x80/4.5mcg QD, Symb. pMDI 2x80/4.5mcg Bid and to Budesonide pMDI 2x160 Mcg QD in Asthmatic Sub's12yrs and Over
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 615
- Primary Endpoint
- Change from start of treatment in evening pre-dose FEV1
Study Overview
Brief Summary
The purpose of this study is to determine whether treatment with Symbicort for 12 weeks will improve lung function and symptoms of adults and adolescents with asthma.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 12 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of asthma
- •Baseline lung function tests as determined by protocol.
- •Required and received treatment with inhaled corticosteroids and/or lung treatments specified in the protocol within timeframe and doses specified in protocol.
Exclusion Criteria
- •Severe asthma
- •Has required treatment with any non-inhaled corticosteroid within previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers
- •Had cancer within previous 5 years or currently has any other significant disease or disorder as judged by the investigator
Arms & Interventions
1
Experimental
Intervention: budesonide/formoterol (Symbicort) (Drug)
Outcomes
Primary Outcomes
Change from start of treatment in evening pre-dose FEV1
Time Frame: 2, 6 and 12 weeks after starting treatment
Secondary Outcomes
- Change from before treatment in lung function, symptoms, use of rescue medication and patient-physician reported outcomes(Daily)
- Investigate safety profile of Symbicort and budesonide(Before and 2, 4, 12 weeks after start of treatment and 1 week after end of treatment)
Investigators
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