Pulmicort Asthma Prevention (Post-PAC)

NCT ID: NCT00233584

Last Updated: 2008-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-07-31
• Study Completion Date: 2006-06-30

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.

Conditions

Asthma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Pulmicort (budesonide) pMDI

Intervention Type: PROCEDURE

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.

• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Principal Investigators

AstraZeneca Denmark Medical Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

Research Site

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

D5254C00004

Identifier Type: -

Identifier Source: org_study_id