New Version Pulmicort Turbuhaler USA Children
New Version Pulmicort Turbuhaler USA Children
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.
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.