Study to Investigate Real Life Effectiveness of Symbicort Maintenance and Reliever Therapy in Asthma Patients Across Asia - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00939341

Purpose

The purpose of this study is to compare whether Symbicort Maintenance & Reliever Therapy (SMART) is more effective in uncontrolled asthmatic patients than their current therapy in a real life situation.

Condition	Intervention	Phase
Asthma	Drug: Symbicort (Budesonide/Formoterol)	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment
Official Title:	Real Life Effectiveness of Symbicort Maintenance and Reliever Therapy (SMART) in Asthma Patients Across Asia: SMARTASIA

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:

Change in Asthma Control Questionnaire (ACQ(5)) score from baseline at a regional level [ Time Frame: At initiate study treatment visit with 3 further visits at 4, 8 and 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in ACQ (5) score from baseline at country level [ Time Frame: At initiate study treatment visit with 3 further visits at 4, 8 and 12 weeks ] [ Designated as safety issue: No ]
Change in Asthma Quality of Life Questionnaire, standardized version (AQLQ (S)) domain and overall scores from baseline [ Time Frame: At initiate study treatment visit with 3 further visits at 4, 8 and 12 weeks ] [ Designated as safety issue: No ]
Study medication use (maintenance and reliever) in Diary Cards [ Time Frame: At initiate study treatment visit with 2 further visits at 4 and 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	1000
Study Start Date:	July 2009
Estimated Study Completion Date:	April 2010

Arms	Assigned Interventions
1: Experimental Symbicort Turbuhaler 160/4.5 µg delivered dose	Drug: Symbicort (Budesonide/Formoterol) Turbuhaler 160/4.5 µg delivered dose, twice daily (one inhalation in the morning and one inhalation in the evening) and as need (prn) in response to symptoms

Eligibility

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

Criteria

Inclusion Criteria:

Provision of signed informed consent
Asthma diagnosis at least 6 months before visit 1 of study
Patients who have reversible airway obstruction continuous asthma treatment except Symbicort at least within 4 weeks before visit 1 of study

Exclusion Criteria:

Known or suspected allergy to active ingredients of study medication or excipients
Use of oral, rectal or parenteral glucocorticosteroids 30 days before visit 1 of study
Smoking, current or previous with a smoking history of ≥ 10 pack years

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00939341

Contacts

Contact: AstraZeneca Thailand Clinical Study Information

+66 2 739 7400

nongluk.yimsuan@astrazeneca.com

Show 33 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Joher Raniwalla, MD

AstraZeneca

More Information

No publications provided

Responsible Party:	AstraZeneca ( MC MD )
Study ID Numbers:	D5890L00035
Study First Received:	July 13, 2009
Last Updated:	July 23, 2009
ClinicalTrials.gov Identifier:	NCT00939341 History of Changes
Health Authority:	China: Ethics Committee; India: Ministry of Health; Indonesia: Departement Kesehatan (Department of Health); New Zealand: Institutional Review Board; Taiwan: Institutional Review Board; Thailand: Ethical Committee

Keywords provided by AstraZeneca:

Symbicort SMART

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 February 09, 2010