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

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ClinicalTrials.gov Identifier: NCT00421122
Recruitment Status : Completed
First Posted : January 11, 2007
Last Update Posted : March 27, 2009
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: budesonide/formoterol (Symbicort) Drug: budesonide (Pulmicort) Drug: terbutaline sulfate (Bricasol) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 315 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : September 2006
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Budesonide

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Post-study medication FEV1 [ Time Frame: 1 hour after medication ]

Secondary Outcome Measures :
  1. FVC [ Time Frame: Pre dose and 1 hour post dose ]
  2. FEV1 [ Time Frame: Pre-dose and 15 minutes post dose ]
  3. SGRQ symptom scores
  4. COPD symptom scores
  5. morning and evening PEF [ Time Frame: Assessed daily ]
  6. reliever medication use
  7. AE
  8. lab measures
  9. ECG
  10. physician examination
  11. vital signs


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00421122     History of Changes
Other Study ID Numbers: D5892C00013
First Posted: January 11, 2007    Key Record Dates
Last Update Posted: March 27, 2009
Last Verified: March 2009

Keywords provided by AstraZeneca:
Chinese patients
COPD

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Formoterol Fumarate
Budesonide
Terbutaline
Budesonide, Formoterol Fumarate Drug Combination
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Sympathomimetics
Tocolytic Agents
Reproductive Control Agents