Pulmicort Asthma Prevention (Post-PAC)

AstraZeneca400 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

400

Conditions

Asthma

Interventions

Pulmicort (budesonide) pMDIPROCEDURE

Eligibility

Sex: ALLMax age: 6 Years

Medical Language ↔ Plain English

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.

Locations (1)

Research Site

Copenhagen, Denmark

Outcomes

Primary Outcomes

Success rate of the treatment algorithm: Frequency of protocol deviations, asthma exacerbations, different treatment steps.

Efficacy - development of lung function.

Secondary Outcomes

Acceptability of the treatment algorithm by the parents.

Growth rate and BMD.

Exhaled nitrogen Oxide, bronchohyperresponsiveness.

Data from ClinicalTrials.gov

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