Gemini Symbicort pMDI

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Mild or Moderate Asthma

Treatments: Drug: budesonide/formoterol (Symbicort)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00646516

D5896C00001

Details and patient eligibility

About

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.

Enrollment: 615 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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615 participants in 1 patient group

1

Experimental group

Treatment:

Drug: budesonide/formoterol (Symbicort)