New Version Pulmicort Turbuhaler USA Children

Condition(s) targeted: Asthma

Intervention: budesonide (Drug)

Phase: Phase 3

Status: Completed

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

Secondary outcome:

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. Gender(s): Both.

Criteria:

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.

Starting date: November 2002
Ending date: December 2004
Last updated: March 18, 2008