Real Life Effectiveness in Patients With Not Optimally Co... | NCT01647646

Studies
Real Life Effectiveness in Patients With Not Optimally Controlled Asthma

NCT01647646

Sponsor

Far Eastern Memorial Hospital

Status

Completed

Last Update Posted

Jul 24, 2012Estimated

Enrollment

200Actual

Phase

Phase 4

Conditions

Asthma

Interventions

Seretide

Countries

Not provided

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 2012

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

Mar 2009

Primary Completion Date

Feb 2011Actual

Completion Date

Mar 2012Actual

First Submitted Date

Jul 19, 2012

First Submission Date that Met QC Criteria

Jul 20, 2012

First Posted Date

Jul 23, 2012Estimated

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 23, 2012

Last Update Posted Date

Jul 24, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Shih-Lung Cheng, Chief, Division of Pulmonary Medicine, Far Eastern Memorial HospitalPrincipal Investigator

Lead Sponsor

Far Eastern Memorial HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

In real life, the investigators will be using different strategies including SMART therapy or other ICS/LABA (medium and high dose) therapy and measure the efficacy for asthma control.

Detailed Description

All not-well controlled asthma patients would include the study.
We will compare three ways of asthma control including SMART, fixed doses with regular doses and fixed doses with higher doses
We will evaluate the efficacy/safety for these not-well controlled patients.

Design Module

Study Type

Interventional

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Symbicort	Active Comparator	We will evaluate the efficacy fot Symbicort use. The usage was 2 doses bid for one year period. Intervention drug: Seretide fixed doses therapy	Drug: Seretide
Seretide	Experimental	In non-well asthma controlled patients, experimental study with Seretide regular doses (125 2 doses bid for one year) and higher doses (250 2 doses bid) for one year	Drug: Seretide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Seretide	Drug	Using Symbicort and Seretide for asthma control measurements Compared with efficacy and safety	Seretide Symbicort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the percentage of asthma total and well control	F/U clinical asthma control status and percentage of Acute exacerbation	one year

Secondary Outcomes

Measure	Description	Time Frame
percentage of asthma acute exacerbation		one year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

asthma not well control

Exclusion Criteria:

COPD

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

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

Intervention Browse Module

MeSH Terms

ID	Term
D000068297	Fluticasone-Salmeterol Drug Combination

Ancestor Terms

ID	Term
D000068299	Salmeterol Xinafoate
D000420	Albuterol
D004983	Ethanolamines
D000605	Amino Alcohols

Browse Leaves

Not provided

Browse Branches

Not provided