Efficacy and Safety Study of Symbicort Turbuhaler in Chinese Patients With COPD - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00421122

Purpose

This study aims at evaluating efficacy and safety of Symbicort® Turbuhaler® in Chinese COPD patients as defined by GOLD treatment guidelines in order to obtain an approval for indication of COPD from Chinese State Food and Drug Administration.

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease	Drug: budesonide/formoterol (Symbicort) Drug: budesonide (Pulmicort) Drug: terbutaline sulfate (Bricasol)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A 6-Month, Phase IIIA, Multi-Center,Randomised,Double-Blind, Double-Dummy, Parallel-Group Study of the Efficacy and Safety of Symbicort® Turbuhaler®+ Bricasol® pMDI Compared With Pulmicort® Turbuhaler®+Bricasol® pMDI in Chinese Patients With COPD

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Terbutaline Terbutaline sulfate Budesonide Formoterol Symbicort

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Post-study medication FEV1 [ Time Frame: 1 hour after medication ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

FVC [ Time Frame: Pre dose and 1 hour post dose ] [ Designated as safety issue: No ]
FEV1 [ Time Frame: Pre-dose and 15 minutes post dose ] [ Designated as safety issue: No ]
SGRQ symptom scores
COPD symptom scores
morning and evening PEF [ Time Frame: Assessed daily ] [ Designated as safety issue: No ]
reliever medication use
AE
lab measures
ECG
physician examination
vital signs

Enrollment:	315
Study Start Date:	September 2006
Study Completion Date:	November 2007

Arms	Assigned Interventions
1: Active Comparator Bricasol®	Drug: terbutaline sulfate (Bricasol) inhalation therapy
2: Experimental Bricasol® + Pulmicort®	Drug: budesonide (Pulmicort) inhalation Drug: terbutaline sulfate (Bricasol) inhalation therapy
3: Experimental Bricasol® + Symbicort®	Drug: budesonide/formoterol (Symbicort) inhalation therapy Drug: terbutaline sulfate (Bricasol) inhalation therapy

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Signed and dated inform consent
Out-patient, clinical diagnosis of COPD
Men or women at the age of 40 or over

Exclusion Criteria:

A history of asthma
Seasonal allergic rhinitis before 40 years of age
Patients with significant or unstable ischemic heart disease, arrhythmia, cardiomyopathy, heart failure, uncontrolled hypertension as defined by the investigator or other disorder

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00421122

Locations

China
Research Site
Beijing, China
Research Site
Shanghai, China
China, Guangdong
Research Site
Guangzhou, Guangdong, China
China, Jiangsu
Research Site
Nanjing, Jiangsu, China
China, Liaoling
Research Site
Shenyang, Liaoling, China
China, Shanxi
Research Site
Xi'an, Shanxi, China
China, Sichuan
Research Site
Chengdu, Sichuan, China
China, Zhejiang
Research Site
Hangzhou, Zhejiang, China

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Symbicort Medical Science Director, MD

AstraZeneca

More Information

No publications provided

Study ID Numbers:	D5892C00013
Study First Received:	January 9, 2007
Last Updated:	March 26, 2009
ClinicalTrials.gov Identifier:	NCT00421122 History of Changes
Health Authority:	China: State Food and Drug Administration

Keywords provided by AstraZeneca:

Chinese patients
COPD

Study placed in the following topic categories:

Anti-Inflammatory Agents
Neurotransmitter Agents
Symbicort
Adrenergic Agents
Adrenergic beta-Agonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Budesonide
Anti-Asthmatic Agents
Hormones

Glucocorticoids
Adrenergic Agonists
Terbutaline
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Formoterol
Peripheral Nervous System Agents
Bronchodilator Agents
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

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

Tocolytic Agents
Therapeutic Uses
Adrenergic beta-Agonists
Sympathomimetics
Budesonide
Anti-Asthmatic Agents
Glucocorticoids
Pharmacologic Actions
Autonomic Agents
Lung Diseases
Peripheral Nervous System Agents
Bronchodilator Agents
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on September 09, 2009