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

AstraZeneca750 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

750

Conditions

Asthma

Interventions

budesonide/formoterolDRUG

budesonide and placeboDRUG

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in evening PEF

Time frame: Daily throughout the 12 week treatment period

Secondary Outcomes

Lung function, asthma symptoms, use of rescue medication and parent/caregiver/physician reported outcomes

Time frame: Daily throughout the 12 week treatment period

Health-related quality of life

Time frame: 4 assessments within 12 week treatment period

Routine safety assessments

Time frame: 4 assessments within 12 week treatment period

Data from ClinicalTrials.gov

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