Utilization Patterns of Pulmicort in Real Life Practice | NCT00660569

Studies
Utilization Patterns of Pulmicort in Real Life Practice

NCT00660569

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Dec 1, 2010Estimated

Enrollment

260Actual

Phase

Not provided

Conditions

Asthma

Interventions

Not provided

Countries

Spain

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

Nov 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

Jan 2008

Primary Completion Date

Not provided

Completion Date

Feb 2009Actual

First Submitted Date

Apr 15, 2008

First Submission Date that Met QC Criteria

Apr 15, 2008

First Posted Date

Apr 17, 2008Estimated

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

Nov 30, 2010

Last Update Posted Date

Dec 1, 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

The purpose of this study is to identify the potential issues during short and mid term utilization of Pulmicort hydro fluoroaklane (HFA) pressurized metered-dose inhaler (pMDI)and describe associated factors.

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

260Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Asthmatic patients with a diagnose of at least 12 months of duration before study inclusion, previously treated with Pulmicort chlorofluorocarbons (CFC) who have changed their treatment to Pulmicort HFA

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Asthmatic patients with a diagnose of at least 12 months of duration before study inclusion
Patients previously treated with Pulmicort CFC who have changed their treatment to Pulmicort HFA

Exclusion Criteria:

Disability that, from investigator point of view, prevent from complying the follow up schedule
To have participated in any clinical study in the past 6 months

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Population treated by General Practitioner, Pneumologists or Paediatricians

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Javier Nuevo Rivero	AstraZeneca MC SpainEpidemiologyValue Demonstration Unit	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Barcelona	Barcelona		Spain
Research Site

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma
D010342	Patient Acceptance of Health Care

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