Pulmicort Asthma Prevention (Post-PAC)

Asthma Clinical Trial

Official title:

A Study to Evaluate the Feasibility of a Treatment Algorithm in Newly Diagnosed Asthmatic Children. An Open Follow-up to Asthma Prevention in Infants/Young Children (PAC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00233584
• Other study ID #: D5254C00004
• Status: Completed
• Phase: N/A
• First received: October 4, 2005
• Last updated: January 11, 2008
• Start date: July 2001
• Est. completion date: June 2006

Study information

• Verified date: January 2008
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: June 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 6 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Procedure:
• Pulmicort (budesonide) pMDI

Locations

Country	Name	City	State
Denmark	Research Site	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate of the treatment algorithm: Frequency of protocol deviations, asthma exacerbations, different treatment steps.
Primary	Efficacy - development of lung function.
Secondary	Acceptability of the treatment algorithm by the parents.
Secondary	Growth rate and BMD.
Secondary	Exhaled nitrogen Oxide, bronchohyperresponsiveness.