A 6-week Study in Asthmatic Children Aged 6 to <12 Yrs Comparing Budesonide pMDI 160ug Twice Daily With Placebo

Phase 2, double-blind, randomized, parallel-group, placebo-controlled, multicenter study,
comparing budesonide pMDI 160 �g bid with placebo: a 6-week efficacy and safety study in
children aged 6 to <12 years with asthma

Inclusion Criteria:

- Has a documented clinical diagnosis of asthma for at least 6 months prior to Visit 2
that has required daily inhaled corticosteroid in the low dose range OR LTRA as
monotherapy for at least 30 days prior to Visit 2.

- Has a morning clinic pre-bronchodilator FEV1 measured at least 6 hours after the last
dose of inhaled short acting beta agonist of greater than or equal to 70% and less
than or equal to 95% of predicted normal

- Demonstrated reversibility of FEV1 of ≥12% from pre short acting beta agonist level
within 15 to 30 minutes after administration of a standard dose of short acting beta
agonist OR has a documented reversibility of ≥ 12 % within 12 months prior to Visit
2.

Exclusion Criteria:

- Has been hospitalized at least once or required emergency treatment (was seen in the
emergency room or had an urgent care visit) more than once for an asthma-related
condition during the 6 months prior to Visit 2

- Has required treatment with systemic corticosteroids (eg, oral, parenteral, or
rectal) for any reason within the 12 weeks prior to Visit 2