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PreAsthmaControl (PAC)

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ClinicalTrials.gov Identifier: NCT00234390
Recruitment Status : Completed
First Posted : October 7, 2005
Last Update Posted : January 24, 2011
Sponsor:
Information provided by:
AstraZeneca

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Asthma Drug: Pulmicort (budesonide) pMDI Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Prevention of Asthma in Infants/Young Children - PAC
Study Start Date : November 1998
Actual Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

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

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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

Eligibility Criteria
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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00234390


Locations
Denmark
Research Site
Copenhagen, Denmark
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca AB CNS Medical Science Director, MD AstraZeneca
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

ClinicalTrials.gov Identifier: NCT00234390     History of Changes
Other Study ID Numbers: SD-004-0299
First Posted: October 7, 2005    Key Record Dates
Last Update Posted: January 24, 2011
Last Verified: January 2011

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