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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

Tracking Information
First Submitted Date  ICMJE October 5, 2005
First Posted Date  ICMJE October 7, 2005
Last Update Posted Date January 24, 2011
Study Start Date  ICMJE November 1998
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2005)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 11, 2006)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2005)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PreAsthmaControl (PAC)
Official Title  ICMJE Prevention of Asthma in Infants/Young Children - PAC
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE Drug: Pulmicort (budesonide) pMDI
Study Arms  ICMJE Not Provided
Publications * Bisgaard H, Hermansen MN, Loland L, Halkjaer LB, Buchvald F. Intermittent inhaled corticosteroids in infants with episodic wheezing. N Engl J Med. 2006 May 11;354(19):1998-2005.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: October 5, 2005)
400
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 6 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00234390
Other Study ID Numbers  ICMJE SD-004-0299
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AstraZeneca AB CNS Medical Science Director, MD AstraZeneca
PRS Account AstraZeneca
Verification Date January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP