The purpose of this study is to address an Food Drug and Administration (FDA) request to provide safety data in pre-asthmatic patients, ages 6 months to <12 months, following administration of fluticasone propionate HFA.

A repeat-dose, open-label, 2-session study to assess the systemic exposure to, and pharmacodynamics of, fluticasone propionate HFA inhalation aerosol 88mcg administered twice-daily for 28 days delivered via an MDI and valved holding chamber with infant facemask to subjects ages 6 months to <12 months who have experienced 2 or more wheezing episodes in the preceding 6 months

Inclusion Criteria:

• Subjects who have experienced 2 or more wheezing episodes in the previous 6 months.
• Subjects may not have taken any corticosteroids in the 4 weeks prior to dosing
• Parents/guardians should be able to read and comprehend diary information collected throughout the study
• Parents must be able to demonstrate the ability to use the facemask and spacer used to administer study drug

Exclusion criteria:

• Subjects who weigh less than 7 kg
• Subjects who are taking any drugs that inhibit or induce the cytochrome P450 isoform
• Any parents who have a history of psychiatric disease, intellectual deficiency, substance abuse that would compromise the validity of the consent

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.