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Completed

NCT Number: NCT00234390

PreAsthmaControl (PAC)

The purpose of this study is to investigate the ability of budesonide, given during episodes of troublesome lung symptoms to reduce further symptoms in infants and young children at risk of developing asthma

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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 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

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 of asthmatic mothers form the COPSAC birth cohort study

Exclusion criteria

  • Children born more than 4 weeks preterm
  • children with other systemic illness that atopy/allergy
  • Children requiring mechanical ventilation at any time since birth.

Treatment and study plan

Pulmicort (budesonide) pMDI

Drug

Primary outcomes

  1. symptom free days

  2. days with no use of bronchodilator

  3. days with no use of bronchodilator and no symptoms

  4. number of treated episodes

  5. number of treatment with add-on medication

Secondary outcomes

  1. asthma status

  2. time to start of algorithm treatment

  3. the total steroid dose

  4. First treatment episode:

  5. number of symptom days

  6. number of days with use of bronchodilator

  7. number of patients who needed add-on medication

  8. BMD

  9. height

  10. serious adverse events

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Prevention of Asthma in Infants/Young Children - PAC

Important dates

Study start
1998
Study completion
2004
First posted
Oct 7, 2005
Registry last updated
Jan 24, 2011

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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