Titratable Dosing in Moderate to Severe Asthmatics

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: budesonide/formoterol; Drug: Symbicort pMDI + budesonide HFA pMDI

Study type: Interventional

Funder types: Industry

Identifiers

NCT00651768

SD-039-0728

D5896C00728

Details and patient eligibility

About

The purpose of this study is to compare the long term safety of Symbicort with budesonide alone, in adolescents and adults with asthma.

Enrollment: 570 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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570 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: budesonide/formoterol

2

Sham Comparator group

Treatment:

Drug: Symbicort pMDI + budesonide HFA pMDI