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

Launched by SKYEPHARMA AG · Oct 30, 2006

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Eligibility criteria

• • Ages eligible for study: 12 years and above
• • Genders eligible for study: both
• • Prior steroid use: steroid-requiring or steroid-free
• Inclusion Criteria:
• • History of asthma for at least 12 months
• • For steriod-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.
• Exclusion Criteria:
• Patients will not be eligible for the study if they meet any of the following criteria:
• • Life-threatening asthma within the past year or during the Run-In Period.
• • History of systemic corticosteroid medication within 3 months before the Screening Visit.
• • History of omalizumab use within past 6 months.
• • History of leukotriene receptor antagonist use, e.g., montelukast, within past week.
• • Current evidence or history of any clinically significant disease or abnormality including uncontrolled hypertension, uncontrolled coronary artery disease, congestive heart failure, myocardial infarction, or cardiac dysrhythmia.
• • Upper or lower respiratory infection within 4 weeks prior to Screening Visit or during Run-In Period.
• • Significant, non-reversible, pulmonary disease (e.g., chronic obstructive pulmonary disease \[COPD\], cystic fibrosis, bronchiectasis).
• • Known Human Immunodeficiency Virus (HIV)-positive status.
• • Smoking history equivalent to "10 pack years".
• • Current smoking history within 12 months prior to Screening Visit.
• • Current evidence or history of alcohol and/or substance abuse within 12 months prior to Screening Visit.
• • Patients who are confined in institution.