Symbicort SMART Satisfaction From Patient Perspective 2009 | NCT00946452

Studies
Symbicort SMART Satisfaction From Patient Perspective 2009

NCT00946452

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Mar 18, 2010Estimated

Enrollment

205Actual

Phase

Not provided

Conditions

Asthma

Interventions

Not provided

Countries

Malaysia

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

Mar 2010

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

Aug 2009

Primary Completion Date

Jan 2010Actual

Completion Date

Jan 2010Actual

First Submitted Date

Jul 24, 2009

First Submission Date that Met QC Criteria

Jul 24, 2009

First Posted Date

Jul 27, 2009Estimated

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

Mar 17, 2010

Last Update Posted Date

Mar 18, 2010Estimated

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

To characterize the level of asthma control and patient satisfaction amongst diagnosed asthma sufferers who are currently receiving Symbicort Maintenance and Reliever Therapy (SMART) in Malaysia.

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

205Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Score level of Satisfaction in Asthma Treatment Questionnaire (SATQ)		After 3 months on SMART - once
Score level of Asthma Control Test (ACT)		After 3 months on SMART - once

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Have been prescribed Symbicort SMART (1 or 2 inhalation twice daily) by their Dr's for the past 3 months
Informed consent

Exclusion Criteria:

Symbicort SMART treatment < 3 months
Patients requiring short courses of oral steroids more than twice in a month

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

59 Years

Standard Ages

Adult

Study Population

Primary care clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Liam Chong Kin, Professor	UMMC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Petaling Jaya	Selangor		Malaysia

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma
D010549	Personal Satisfaction

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