A Comparison of the Control of Asthma Provided by Symbicort® Turbuhaler® Versus Symbicort® Turbuhaler® Plus Pulmicort® Turbuhaler® Plus Terbutaline Turbuhaler®

AstraZeneca100 enrolled

Overview

The purpose of this study is to determine if a flexible dose of Symbicort has a similar effect on the airways of patients with asthma as a higher fixed-dose of Symbicort with additional glucocorticosteroids added.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Asthma

Interventions

Budesonide/Formoterol TurbuhalerDRUG

Budesonide Turbuhaler (Pulmicort)DRUG

Terbutaline TurbuhalerDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of asthma for at least 6 months * Prescribed daily use of glucocorticosteroids for at least 3 months prior to visit one Exclusion Criteria: * Respiratory infection affecting asthma within 30 days prior to study * Intake of oral, rectal, or parenteral glucocorticosteroids within 30 days prior to study * Any significant disease or disorder that may jeopardize the safety of the patient

Locations (22)

Research Site

Aalborg, Denmark

Research Site

Århus C, Denmark

Outcomes

Primary Outcomes

Change in eosinophils in bronchial biopsies (first and last visit) and in sputum (5 times during the 12-month treatment period)

Secondary Outcomes

Immunopathology and remodeling in biopsies

Immunopathology and mediators in induced sputum

Severe asthma exacerbations (number of and time to first)

Forced expiratory volume in 1 second (FEV1)

As-needed use

Safety variables, including adverse events and vital signs

All variables assessed over the 12-month treatment period

Data from ClinicalTrials.gov

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