Prevention of Asthma Relapse After Discharge From Emergency | NCT00326053

Studies
Prevention of Asthma Relapse After Discharge From Emergency

NCT00326053

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Jan 24, 2011Estimated

Enrollment

600Estimated

Phase

Phase 3

Conditions

Asthma

Interventions

Budesonide/formoterol

Countries

Canada

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
PARADE

Status Module

Record Verification Date

Jan 2011

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

May 2006

Primary Completion Date

Not provided

Completion Date

May 2007Actual

First Submitted Date

May 12, 2006

First Submission Date that Met QC Criteria

May 12, 2006

First Posted Date

May 16, 2006Estimated

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

Jan 21, 2011

Last Update Posted Date

Jan 24, 2011Estimated

Description Module

Brief Summary

The purpose of this study is to compare the Symbicort® Turbuhaler® to both Pulmicort® Turbuhaler® and Bricanyl® Turbuhaler® for the treatment of asthma after discharge from the emergency room

Detailed Description

Not provided

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

600Estimated

Name	Type	Description	Arm Group Labels	Other Names
Budesonide/formoterol	Drug			Symbicort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to first asthma relapse

Secondary Outcomes

Measure	Description	Time Frame
Mean use of reliever medication
Asthma Control Questionnaire (ACQ) score
Complete AE and SAE collection

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 - 65 years of age
Presenting at a study emergency department with an asthma exacerbation

Exclusion Criteria:

Admission to hospital
Patients receiving more than 2000 µg/day of beclomethasone equivalent inhaled corticosteroids (1000 µg/day fluticasone or 1600 µg/day budesonide)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gloria Jordana, MD	AstraZeneca	Study Director
Brian Rowe, MD	University of Alberta	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Calgary	Alberta		Canada
Research Site

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma
D004630	Emergencies

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
D000069502	Budesonide, Formoterol Fumarate Drug Combination

Ancestor Terms

ID	Term
D000068759	Formoterol Fumarate
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols

Browse Leaves

Not provided

Browse Branches

Not provided