Local Phase 4 Pan-European SMART Study

AstraZeneca

Status and phase

Completed

Phase 4

Conditions

Asthma

Treatments

Drug: Budesonide/formoterol

Study type

Interventional

Funder types

Industry

Identifiers

NCT00463866

D5890L00022

EudraCTNo. 2006-006512-30

EUROSMART

Details and patient eligibility

About

The purpose of this study is to evaluate the effect of two different maintenance doses of Symbicort Maintenance And Reliever Therapy (SMART) in adult asthmatic patients. A 6 month treatment period

Enrollment

8,424 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients at out-patient clinics
>18 years with a minimum of 6 months documented history of persistent asthma who have used inhaled glucocorticosteroids for at least one month and have a history of use in rapid-acting B2 agonists for symptom relief

Exclusion criteria

Asthma exacerbation within the last 14 days prior to study start
subject aged >40 years with a smoking history of >10pack-years
subjects with chronic obstructive lung disease or other significant respiratory disease