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

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

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

Study Type:	Interventional
Study Design:	Allocation: Randomized, Control: Historical Control, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Official Title:	Real Life Effectiveness in Asthma of Symbicort Single Inhaler Therapy

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Formoterol fumarate Budesonide Arformoterol Formoterol Symbicort Arformoterol Tartrate

U.S. FDA Resources

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
Study Completion Date:	December 2006

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

No publications provided

Study ID Numbers:	D5890L00012, RELEASE
Study First Received:	April 27, 2006
Last Updated:	March 16, 2009
ClinicalTrials.gov Identifier:	NCT00319306 History of Changes
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

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Symbicort
Bronchial Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Adrenergic Agonists
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Therapeutic Uses

Formoterol
Immune System Diseases
Adrenergic beta-Agonists
Budesonide
Asthma
Anti-Asthmatic Agents
Glucocorticoids
Pharmacologic Actions
Autonomic Agents
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on March 18, 2010