Titratable Dosing in Moderate to Severe Asthmatics

AstraZeneca570 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

570

Conditions

Asthma

Interventions

budesonide/formoterolDRUG

Symbicort pMDI + budesonide HFA pMDIDRUG

Symbicort 2 X 160/4.5mcg \& budesonide HFA pMDI 4 X 160mcg

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Asthma exacerbations, ECG and Holter monitors, lung function, adverse events, requirement of other asthma therapies and other routine safety assessments.

Time frame: 7 assessments within 12 month treatment period

Secondary Outcomes

To measure changes in lung function tests, patient reported outcomes and usage of medical resource

Time frame: 7 assessments within 12 month treatment period

Blood levels of budesonide and formoterol

Time frame: 10 blood samples taken at 1 visit in a sub-set of patients

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.