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New Version Pulmicort Turbuhaler USA Children
This study has been completed.
Study NCT00642161   Information provided by AstraZeneca
First Received: March 18, 2008   Last Updated: March 24, 2009   History of Changes

March 18, 2008
March 24, 2009
November 2002
September 2004   (final data collection date for primary outcome measure)
Change from Baseline in % predicted Forced Expiratory Volume in 1 second [ Time Frame: Week 2, 4 and 8, then at week 12 ]
Same as current
Complete list of historical versions of study NCT00642161 on ClinicalTrials.gov Archive Site
  • Change from baseline in Forced Vital Capacity, Morning Peak Expiratory Flow, Daytime and nighttime asthma symptom scores, beta-agonist use and discontinuation rate [ Time Frame: Week 2, 4 and 8, then at week 12 ]
  • Incidence of Adverse Events [ Time Frame: Week 2, 4 and 8, then at week 12 ]
  • Pharmacokinetics of budesonide (AUC, maximum concentration and time to maximum concentration [ Time Frame: 6 or 12 hours post dose ]
Same as current
 
New Version Pulmicort Turbuhaler USA Children
A Placebo-Controlled Comparison of the Efficacy, Safety and Pharmacokinetics of the Current US Version of Pulmicort (Budesonide) Turbuhaler and the New Version of Pulmicort Turbuhaler in Asthmatic Children and Adolescents.

A comparison of the safety, efficacy and budesonide pharmacokinetics of the currently approved Pulmicort Turbuhaler with a new version of the inhaler, in children and adolescents who have asthma. In addition the study evaluated the functionality of the new inhaler at the end of its intended life.

 
Phase III
Interventional
Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Asthma
Drug: budesonide
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
430
September 2004
September 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or females aged 6 to 17 with a diagnosis of asthma for at least 3 months. Have used inhaled corticosteroids for no more than one month before entering the study or none at all.
  • A forced expiratory volume (FEV1) in 1 second of 75% to 90% of predicted normal for those aged 6 to 11 and 60% to 90% for those aged 12 to 17 years.
  • Airway reversibility of at least 12% , use of orally inhaled corticosteroids for no more than one month immediately before entering the study or none at all.

Exclusion Criteria:

  • Life threatening asthma, Two or more overnight hospitalisations for asthma within 1 year or any emergency room visit for asthma within 6 months of starting study.
  • Use of steroid tablets or injections during the month prior to Visit 1 and use of other asthma medicines (except rescue medication) within 2 weeks prior to the study.
  • Any acute exacerbation of asthma or a respiratory tract infection within 30 days prior to Visit 1. Must not smoke or have smoked.
Both
6 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00642161
Lars-Göran Carlsson
SD-004-0726, D5254C00726
AstraZeneca
 
Study Director: Bertil Andersson AstraZeneca employee
Study Director: Lars-Göran Carlsson AstraZeneca employee
AstraZeneca
March 2009

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