Comparison of New Combination Inhaler (FlutiForm HFA MDI 100/10 µg) Versus Fluticasone and Formoterol Administered Alone, and Placebo, in Patients With Asthma

Inclusion Criteria

• •Ages eligible for study: 12 years and above; genders eligible for study: both; prior steroid use: steroid-requiring or steroid-free.
• •History of asthma for at least 12 months.
• •For steroid-requiring patients, documented use of inhaled corticosteroid for at least 4 weeks prior to Screening Visit
• •For steroid-free patients, no history of inhaled steroid asthma medication for at least 12 weeks prior to Screening Visit.
• •Demonstrate FEV-1 of 60-85% of predicted normal values at Screening and Baseline Visit.
• •Documented reversibility of 15% within 12 months of Screening or at Screening Visit (15% increase from pre-FEV-1 levels following albuterol inhalation or nebulized albuterol administration).
• •Symptoms of Asthma during Run-in
• •Females of childbearing potential must have a negative urine pregnancy test at Screening and Baseline Visits. Females are eligible only if they are not pregnant or lactating, and are either sterile, or using acceptable methods of contraception.
• •Must otherwise be healthy.
• •Provide written informed consent. Wishes of minors must be respected.