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OpenTrials
Completed

NCT Number: NCT00233584

Pulmicort Asthma Prevention (Post-PAC)

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

Up to 6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Research Site

Copenhagen, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pulmicort (budesonide) pMDI

Procedure

Primary outcomes

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

  2. Efficacy - development of lung function.

Secondary outcomes

  1. Acceptability of the treatment algorithm by the parents.

  2. Growth rate and BMD.

  3. Exhaled nitrogen Oxide, bronchohyperresponsiveness.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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)

Important dates

Study start
2001
Primary completion
2006
Study completion
2006
First posted
Oct 6, 2005
Registry last updated
Jan 14, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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