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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

January 9, 2007
January 11, 2007
March 27, 2009
September 2006
Not Provided
Post-study medication FEV1 [ Time Frame: 1 hour after medication ]
Post-study medication FEV1(1 hour after medication)
Complete list of historical versions of study NCT00421122 on ClinicalTrials.gov Archive Site
  • FVC [ Time Frame: Pre dose and 1 hour post dose ]
  • FEV1 [ Time Frame: Pre-dose and 15 minutes post dose ]
  • SGRQ symptom scores
  • COPD symptom scores
  • morning and evening PEF [ Time Frame: Assessed daily ]
  • reliever medication use
  • AE
  • lab measures
  • ECG
  • physician examination
  • vital signs
  • pre-study medication and 1hour post study medication FVC
  • pre study medication and 15 min. post study medication FEV1
  • SGRQ symptom scores
  • COPD symptom scores
  • morning and evening PEF
  • reliever medication use
  • AE
  • lab measures
  • ECG
  • physician examination
  • vital signs
Not Provided
Not Provided
 
Efficacy and Safety Study of Symbicort Turbuhaler in Chinese Patients With COPD
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease
  • Drug: budesonide/formoterol (Symbicort)
    inhalation therapy
    Other Name: Symbicort® Turbuhaler
  • Drug: budesonide (Pulmicort)
    inhalation
    Other Name: Pulmicort® Turbuhaler
  • Drug: terbutaline sulfate (Bricasol)
    inhalation therapy
    Other Name: Bricasol pMDI
  • Active Comparator: 1
    Bricasol®
    Intervention: Drug: terbutaline sulfate (Bricasol)
  • Experimental: 2
    Bricasol® + Pulmicort®
    Interventions:
    • Drug: budesonide (Pulmicort)
    • Drug: terbutaline sulfate (Bricasol)
  • Experimental: 3
    Bricasol® + Symbicort®
    Interventions:
    • Drug: budesonide/formoterol (Symbicort)
    • Drug: terbutaline sulfate (Bricasol)
Zhong N, Zheng J, Wen F, Yang L, Chen P, Xiu Q, Yao W, Sun T, Zhao Z, Shen H, Shi Y, Lin J, Li Q. Efficacy and safety of budesonide/formoterol via a dry powder inhaler in Chinese patients with chronic obstructive pulmonary disease. Curr Med Res Opin. 2012 Feb;28(2):257-65. doi: 10.1185/03007995.2011.636420. Epub 2012 Jan 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
315
300
November 2007
Not Provided

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
Sexes Eligible for Study: All
40 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT00421122
D5892C00013
Not Provided
Not Provided
Not Provided
Not Provided
AstraZeneca
Not Provided
Study Director: Symbicort Medical Science Director, MD AstraZeneca
AstraZeneca
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP