Asthma Control-A "Patient Follow up Programme" Maintenanc... | NCT00524641

Studies
Asthma Control-A "Patient Follow up Programme" Maintenance and Reliever Therapy in a Single Inhaler

NCT00524641

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Jul 9, 2009Estimated

Enrollment

1,254Actual

Phase

Not provided

Conditions

Asthma

Interventions

Not provided

Countries

Vietnam

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

ID	Type	Description	Link
NIS-R84-AST-2007/3

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

Mar 2008Actual

Completion Date

Apr 2008Actual

First Submitted Date

Aug 30, 2007

First Submission Date that Met QC Criteria

Aug 31, 2007

First Posted Date

Sep 3, 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 8, 2009

Last Update Posted Date

Jul 9, 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

To investigate the change in patient's asthma symptom control using ACQ scores after 4 to 6 weeks of Symbicort Turbuhaler (budesonide/ formoterol) in SMART approach.

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

1,254Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Asthma patients from both sexes, age 18 or older
Have already been on Symbicort SMART treatment
Willing to give written informed consents to participate in the program.

Exclusion Criteria:

Patients who are not willing to give written informed consent
Patients in emergency care for asthma at ICUs or COPD patients are excluded from the program.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Hospital out-patient departments and private clinics in all areas of Vietnam

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dinh Ngoc SY, MD	TB and Lung Disease Hospital, Hanoi	Study Chair
Tran Van Ngoc, MD, PhD	Cho Ray Hospital	Study Chair
Nguyen Hong Duc	Pharm Ngoc Thach Hospital	Study Chair
Do Van Dung, MD, PhD	Ho Chi Minh City Univ of Medicine and Pharmacist	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Hanoi			Vietnam
Research Site

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma

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