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PreAsthmaControl (PAC)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00234390
First received: October 5, 2005
Last updated: January 21, 2011
Last verified: January 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Asthma
 Drug: Pulmicort (budesonide) pMDI
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Prevention of Asthma in Infants/Young Children - PAC

Resource links provided by NLM:

MedlinePlus related topics: Asthma
Drug Information available for: Budesonide
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • symptom free days
  • days with no use of bronchodilator
  • days with no use of bronchodilator and no symptoms
  • number of treated episodes
  • number of treatment with add-on medication

Secondary Outcome Measures:
  • asthma status
  • time to start of algorithm treatment
  • the total steroid dose
  • First treatment episode:
  • number of symptom days
  • number of days with use of bronchodilator
  • number of patients who needed add-on medication
  • BMD
  • height
  • serious adverse events

Estimated Enrollment: 400
Study Start Date: November 1998
Study Completion Date: December 2004
  Eligibility

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00234390

Locations
Denmark
Research Site
Copenhagen, Denmark
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca AB CNS Medical Science Director, MD AstraZeneca
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00234390     History of Changes
Other Study ID Numbers: SD-004-0299
Study First Received: October 5, 2005
Last Updated: January 21, 2011
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Bronchodilator Agents
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 21, 2013