An Efficacy Study Comparing SYMBICORT® Pressurised Metered Dose Inhaler (pMDI) With Budesonide Hydrofluoroalkanes (HFA) pMDI, in Hispanic Subjects With ICS Dependent Asthma

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Budesonide/formoterol (SYMBICORT) pMDI; Drug: Budesonide HFA pMDI

Study type: Interventional

Funder types: Industry

Identifiers

NCT00419757

D5896C00021

Details and patient eligibility

About

The purpose of this study is to determine the effectiveness and safety of SYMBICORT® pMDI (a medication approved by the Food and Drug Administration(FDA)) in the Hispanic population.

Enrollment: 558 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or Female, Hispanic (self-reported), > 12 years of age
• Moderate to severe asthma requiring treatment with an inhaled corticosteroid
• Diagnosis of asthma for at least 6 months

Exclusion criteria

• Subjects requiring treatment with systemic corticosteroids (e.g., oral, parenteral, ocular)
• Any significant disease or disorder that may jeopardize a subject's safety

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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558 participants in 2 patient groups

Symbicort

Active Comparator group

Description:

SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily

Treatment:

Drug: Budesonide/formoterol (SYMBICORT) pMDI

Budesonide

Active Comparator group

Description:

budesonide HFA pMDI 160 μg x 2 actuations twice daily

Treatment:

Drug: Budesonide HFA pMDI