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Efficacy and Safety Study of Symbicort Turbuhaler in Chinese Patients With COPD

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00421122
First received: January 9, 2007
Last updated: March 26, 2009
Last verified: March 2009
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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:

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
Active Comparator: 1
Bricasol®
 Drug: terbutaline sulfate (Bricasol)
inhalation therapy
Other Name: Bricasol pMDI
Experimental: 2
Bricasol® + Pulmicort®
 Drug: budesonide (Pulmicort)
inhalation
Other Name: Pulmicort® Turbuhaler
Drug: terbutaline sulfate (Bricasol)
inhalation therapy
Other Name: Bricasol pMDI
Experimental: 3
Bricasol® + Symbicort®
 Drug: budesonide/formoterol (Symbicort)
inhalation therapy
Other Name: Symbicort® Turbuhaler
Drug: terbutaline sulfate (Bricasol)
inhalation therapy
Other Name: Bricasol pMDI

  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, Beijing
Research Site
Beijing, Beijing, China
China, Guangdong
Research Site
Guangzhou, Guangdong, China
China, Jiangsu
Research Site
Nanjing, Jiangsu, China
China, Liaoling
Research Site
Shenyang, Liaoling, China
China, Shanghai
Research Site
Shanghai, Shanghai, 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 by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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

Keywords provided by AstraZeneca:
Chinese patients
COPD

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Terbutaline
Budesonide
Formoterol
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
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 19, 2013