Local Phase 4 Pan-European SMART Study - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00463866

Purpose

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

Condition	Intervention	Phase
Asthma	Drug: Budesonide/formoterol	Phase IV

MedlinePlus related topics: Asthma

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study

Further study details as provided by AstraZeneca:

Estimated Enrollment:	8000
Study Start Date:	March 2007
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Eligibility

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00463866

Show 820 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:	Michel Aubier, Prof	FRANCE
Study Chair:	Juliette Ostinelli, MD	AstraZeneca, MC France

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	D5890L00022, EUROSMART, EudraCTNo. 2006-006512-30
Study First Received:	April 19, 2007
Last Updated:	May 19, 2008
ClinicalTrials.gov Identifier:	NCT00463866
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products; Finland: National Agency for Medicines; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Greece: National Organization of Medicines; Ireland: Irish Medicines Board; Italy: Ethics Committee; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Norway: The National Committees for Research Ethics in Norway; Russia: Ministry of Health and Social Development of the Russian Federation; Spain: Spanish Agency of Medicines; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Sweden: Medical Products Agency

Keywords provided by AstraZeneca:

Asthma

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 January 16, 2009