New Version Pulmicort Turbuhaler USA Children

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00642161
First received: March 18, 2008
Last updated: January 21, 2011
Last verified: January 2011

March 18, 2008
January 21, 2011
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
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Asthma
Drug: budesonide
Other Name: Pulmicort
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) 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
Not Provided
 
NCT00642161
SD-004-0726, D5254C00726
No
Lars-Göran Carlsson
AstraZeneca
Not Provided
Study Director: Bertil Andersson AstraZeneca employee
Study Director: Lars-Göran Carlsson AstraZeneca employee
AstraZeneca
January 2011

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