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OpenTrials
Completed

NCT Number: NCT00421122

Efficacy and Safety Study of Symbicort Turbuhaler 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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

budesonide/formoterol (Symbicort)

Drug

inhalation therapy

Other names: Symbicort® Turbuhaler

budesonide (Pulmicort)

Drug

inhalation

Other names: Pulmicort® Turbuhaler

terbutaline sulfate (Bricasol)

Drug

inhalation therapy

Other names: Bricasol pMDI

Primary outcomes

  1. Post-study medication FEV1

    Time frame: 1 hour after medication

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2006
Study completion
2007
First posted
Jan 11, 2007
Registry last updated
Mar 27, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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