New Version Pulmicort Turbuhaler USA Adults
New Version Pulmicort Turbuhaler USA Adults
A comparison of the safety, efficacy and budesonide pharmacokinetics of the currently
 approved Pulmicort Turbuhaler with a new version of the inhaler, in adult patients who have
 asthma and are currently being treated with inhaled steroids. In addition the study evaluated
 the functionality of the new inhaler at the end of its intended life.
Inclusion Criteria:

 -  Males and females at least 18 years old with a diagnosis of asthma (as defined by the
 ATS) for at least 6 months.

 -  To enter the run in period, subjects were also required to have the following:

 -  A forced expiratory volume (FEV1) in 1 second of 60% to 90% of predicted normal,
 airway reversibility of at least 12% and 0.20 L, use of orally inhaled corticosteroids
 for at least 3 months prior to the study.

 -  At Visit 2, subjects who met additional entry criteria related to rescue medication
 use and asthma symptom scores during the run in period plus visit specific FEV1
 requirements were assigned to randomized treatments

 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 (28 days) 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 the study. Subject must not smoke or have smoked within 6 months of the study.