Efficacy of Symbicort pMDI Administered Once Daily in Adolescents and Adults During 12 Weeks - STEM

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: budesonide and placebo; Drug: budesonide/formoterol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00652392

D5896C00726

SD-039-0726

Details and patient eligibility

About

The purpose of this study is to compare a dose of Symbicort taken once daily with other dosage regimens of Symbicort , budesonide and placebo for the treatment of asthma in adolescents and adults

Enrollment: 750 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of asthma and baseline lung function tests as determined by the protocol
• Required and received treatment with inhaled corticosteroids within the timeframe and doses specified in the protocol

Exclusion criteria

• Severe asthma
• Has required treatment with any non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in protocol or requires treatment with beta-blockers

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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750 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: budesonide/formoterol

2

Placebo Comparator group

Treatment:

Drug: budesonide and placebo