Pulmicort Asthma Prevention (Post-PAC) | NCT00233584

Studies
Pulmicort Asthma Prevention (Post-PAC)

NCT00233584

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Jan 14, 2008Estimated

Enrollment

400

Phase

Not Applicable

Conditions

Asthma

Interventions

Pulmicort (budesonide) pMDI

Countries

Denmark

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

Jan 2008

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 2001

Primary Completion Date

May 2006Actual

Completion Date

Jun 2006Actual

First Submitted Date

Oct 4, 2005

First Submission Date that Met QC Criteria

Oct 4, 2005

First Posted Date

Oct 6, 2005Estimated

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 11, 2008

Last Update Posted Date

Jan 14, 2008Estimated

Description Module

Brief Summary

This prospective study will evaluate the feasibility of the defined decision tree for the treatment of asthmatic young children. Children who develop episode (=3 consecutive days) of any troublesome lower respiratory symptoms are treated according to a strictly pre-defined multi-steps treatment algorithm until the age of 6 years.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400

Name	Type	Description	Arm Group Labels	Other Names
Pulmicort (budesonide) pMDI	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Success rate of the treatment algorithm: Frequency of protocol deviations, asthma exacerbations, different treatment steps.
Efficacy - development of lung function.

Secondary Outcomes

Measure	Description	Time Frame
Acceptability of the treatment algorithm by the parents.
Growth rate and BMD.
Exhaled nitrogen Oxide, bronchohyperresponsiveness.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children form the COPSAC/PAC study with episodes of troublesome respiratory symptoms. Episodes are defined as 3 consecutive days of any troublesome lower respiratory symptoms.

Exclusion Criteria:

Differential diagnoses including at least a chest x-ray and sweat test.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

6 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
AstraZeneca Denmark Medical Director, MD	AstraZeneca	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Copenhagen			Denmark

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
D019819	Budesonide

Ancestor Terms

ID	Term
D011282	Pregnenediones
D011283	Pregnenes
D011278	Pregnanes
D013256	Steroids
D000072473

Browse Leaves

Not provided

Browse Branches

Not provided