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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: budesonide/formoterol (Symbicort)
* Drug: budesonide (Pulmicort)
* Drug: terbutaline sulfate (Bricasol)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Bricasol® | Drug: terbutaline sulfate (Bricasol)<br>* inhalation therapy<br>* Other names: Bricasol pMDI;|
| Experimental: 2<br>Bricasol® + Pulmicort® | Drug: budesonide (Pulmicort)<br>* inhalation<br>* Other names: Pulmicort® Turbuhaler;Drug: terbutaline sulfate (Bricasol)<br>* inhalation therapy<br>* Other names: Bricasol pMDI;|
| Experimental: 3<br>Bricasol® + Symbicort® | Drug: budesonide/formoterol (Symbicort)<br>* inhalation therapy<br>* Other names: Symbicort® Turbuhaler;Drug: terbutaline sulfate (Bricasol)<br>* inhalation therapy<br>* Other names: Bricasol pMDI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-study medication FEV1 |  | 1 hour after medication | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FVC |  | Pre dose and 1 hour post dose | 
| FEV1 |  | Pre-dose and 15 minutes post dose | 
| SGRQ symptom scores |  |  | 
| COPD symptom scores |  |  | 
| morning and evening PEF |  | Assessed daily | 
| reliever medication use |  |  | 
| AE |  |  | 
| lab measures |  |  | 
| ECG |  |  | 
| physician examination |  |  | 
| vital signs |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Chinese patients