New Version Pulmicort Turbuhaler USA Children
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: budesonide (Drug)
Phase: Phase 3
Sponsored by: AstraZeneca
Official(s) and/or principal investigator(s):
Bertil Andersson, Study Director, Affiliation: AstraZeneca employee
Lars-Göran Carlsson, Study Director, Affiliation: AstraZeneca employee
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.
Official title: 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.
Study design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change from Baseline in % predicted Forced Expiratory Volume in 1 second
Change from baseline in Forced Vital Capacity, Morning Peak Expiratory Flow, Daytime and nighttime asthma symptom scores, beta-agonist use and discontinuation rate
Incidence of Adverse Events
Pharmacokinetics of budesonide (AUC, maximum concentration and time to maximum concentration
Minimum age: 6 Years.
Maximum age: 17 Years.
- 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.
- 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.
Locations and Contacts
Starting date: November 2002
Ending date: December 2004
Last updated: March 18, 2008