Real Life Effectiveness in Asthma of Symbicort Single Inhaler Therapy - Full Text View

Purpose

The purpose of this study is to determine whether patients with asthma are better able to manage and control their symptoms by using one inhaler daily that both prevents as well as treats the symptoms of an asthma exacerbation.

Condition	Intervention	Phase
Asthma	Drug: Budesonide/formoterol Device: Symbicort® Turbohaler®	Phase III

MedlinePlus related topics:

Asthma

ChemIDplus related topics:

Formoterol Arformoterol Arformoterol Tartrate Formoterol fumarate Budesonide Symbicort

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study

Official Title:	Real Life Effectiveness in Asthma of Symbicort Single Inhaler Therapy

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

In a real life setting, to compare Symbicort® Single Inhaler Therapy with a patient's previous therapy (including low dose ICS), by assessment of the changes in the Asthma Control Questionnaire score in uncontrolled asthmatic patients.

Secondary Outcome Measures:

Change in forced expiratory volume in one second (FEV1)
Change in peak expiratory flow (PEF)
Patient Reported Outcomes: AQLQ(S), SATQ, RCP-3 scores

Estimated Enrollment:	550
Study Start Date:	September 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Aged over 18
Confirmed diagnosis of mild to moderate asthma by doctor
Currently receiving inhaled corticoid-steroid medicine for treatment of asthma and requiring a review of current asthma treatment

Exclusion Criteria:

Women who are pregnant, breast-feeding, or planning pregnancy
Patients with a history of chronic obstructive pulmonary disease
Patients using any beta blocker therapy
Patients receiving steroid tablets or steroid injections

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00319306

Show 59 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators


Principal Investigator:	Iain Small, MD	General Practitioner

Study Director:	AstraZeneca UK Medical Director, MD	AstraZeneca

More Information

Study ID Numbers:	D5890L00012, RELEASE
First Received:	April 27, 2006
Last Updated:	March 27, 2007
ClinicalTrials.gov Identifier:	NCT00319306
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:

Respiratory Tract Diseases

Bronchial Diseases

Anti-asthmatic agents

Anti-asthmatic drugs

Bronchodilators

Study placed in the following topic categories:

Hypersensitivity

Lung Diseases, Obstructive

Symbicort

Respiratory Tract Diseases

Lung Diseases

Budesonide

Hypersensitivity, Immediate

Formoterol

Asthma

Respiratory Hypersensitivity

Additional relevant MeSH terms:

Respiratory System Agents

Neurotransmitter Agents

Bronchial Diseases

Immune System Diseases

Adrenergic beta-Agonists

Adrenergic Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Anti-Asthmatic Agents

Adrenergic Agonists

Pharmacologic Actions

Autonomic Agents

Therapeutic Uses

Peripheral Nervous System Agents

Bronchodilator Agents

ClinicalTrials.gov processed this record on October 06, 2008

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00319306