Symbicort SMART (Symbicort Maintenance And Reliever Therapy) | NCT00523679

Studies
Symbicort SMART (Symbicort Maintenance And Reliever Therapy)

NCT00523679

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Jul 13, 2009Estimated

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Asthma

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2007

Primary Completion Date

Not provided

Completion Date

Jul 2008Actual

First Submitted Date

Aug 29, 2007

First Submission Date that Met QC Criteria

Aug 29, 2007

First Posted Date

Aug 31, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 10, 2009

Last Update Posted Date

Jul 13, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to investigate the extent of Symbicort use in patients prescribed Symbicort as maintenance and reliever therapy.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Asthma patients prescribed Symbicort as maintenance and reliever therapy, according to the label, before inclusion in this program.

Exclusion Criteria:

Since this programme intends to describe Symbicort use in routine clinical practice when prescribed as Symbicort maintenance and reliever therapy, there are no programme specific exclusion criteria, other than: involvement in the planning and conduct of the programme (applies to both AstraZeneca staff or staff at the investigational site)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Hospital Outpatient Clinics

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joon-Woo Bahn	AstraZeneca Korea	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Seoul	Jongro-gu		South Korea
Research Site

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma
D010349	Patient Compliance

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided