Study to Investigate the Efficacy of Symbicort SMART. - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00839800

Purpose

The primary objective of this study is to compare the efficacy of Symbicort SMART (Symbicort Turbuhaler 160/4.5μg, one inhalation bid plus as needed) with Symbicort Turbuhaler 160/4.5μg, one inhalation bid plus terbutaline Turbuhaler 0.4 mg as needed, as asthma therapy

Condition	Intervention	Phase
Asthma	Drug: Symbicort Turbuhaler Drug: Terbutaline Turbuhaler	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Comparison of Symbicort® SMART (160/4.5μg) and Symbicort Turbuhaler 160/4.5 μg, Plus Terbutaline Turbuhaler 0.4 mg as Needed, for Treatment of Asthma - a 12-month, Randomized, Double-blind, Parallel Group, Active-controlled, Multinational Phase III Study in Asthmatic Patients From 16 Years

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Terbutaline Terbutaline sulfate Symbicort

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Asthma exacerbations [ Time Frame: daily ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of asthma exacerbations [ Time Frame: End of study period ] [ Designated as safety issue: No ]
Lung function [ Time Frame: daily ] [ Designated as safety issue: No ]
Asthma control [ Time Frame: daily ] [ Designated as safety issue: No ]

Enrollment:	1800
Study Start Date:	February 2009
Study Completion Date:	February 2011
Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Symbicort Turbuhaler 160/4.5 µg one inhalation bid + Symbicort Turbuhaler 160/4.5 µg as needed	Drug: Symbicort Turbuhaler 160/4.5 µg
Active Comparator: 2 Symbicort Turbuhaler 160/4.5 µg one inhalation bid + terbutaline Turbuhaler 0.4 mg as needed	Drug: Symbicort Turbuhaler 160/4.5 µg Drug: Terbutaline Turbuhaler 0.4 mg

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of asthma according to GINA 2007 with a documented history of at least 6 months duration.
Reversible airway obstruction, defined as an increase in FEV1 ≥12% relative to baseline for all patients 15-30 minutes after inhalation of in total 2 x 0.4 mg terbutaline Turbuhaler
Prescribed use of inhaled GCS (any brand) for at least 12 weeks.

Exclusion Criteria:

Respiratory infection affecting the asthma, as judged by the investigator, within 4 weeks.
Intake of oral, rectal or parenteral GCS within 4 weeks and/or depot parenteral GCS within 12 weeks.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00839800

Show 109 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Tomas Andersson, MD	AstraZeneca R&D Lund
Principal Investigator:	Tito Atienza, M.D.	Mary Mediatrix Medical Center, Lipa City, Philippines

More Information

No publications provided

Responsible Party:	Lars-Göran Carlsson, MD, Medical Science Director Symbicort, AstraZeneca
ClinicalTrials.gov Identifier:	NCT00839800 History of Changes
Other Study ID Numbers:	D589LC00001
Study First Received:	February 4, 2009
Last Updated:	May 10, 2011
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Brazil: National Health Surveillance Agency; China: Ministry of Health; China: State Food and Drug Administration; Costa Rica: CEC-UCIMED; Hungary: National Institute of Pharmacy; India: Drugs Controller General of India; Japan: Ministry of Health, Labor and Welfare; Malaysia: Ministry of Health; Philippines: Bureau of Food and Drugs; Russia: Ministry of Health and Social Development of the Russian Federation; South Korea: Korea Food and Drug Administration (KFDA); Thailand: Ethical Committee

Keywords provided by AstraZeneca:

Asthma
Symbicort Turbuhaler

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Terbutaline
Budesonide
Symbicort
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Sympathomimetics
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Glucocorticoids

ClinicalTrials.gov processed this record on February 09, 2012