Clareo Health | New Combination Inhaler (FlutiForm HFA MDI 100/10 µg and 250/10 µg) Versus Fluticasone and Formoterol Administered Alone, and Placebo in Patients With Moderate to Severe Asthma
New Combination Inhaler (FlutiForm HFA MDI 100/10 µg and 250/10 µg) Versus Fluticasone and Formoterol Administered Alone, and Placebo in Patients With Moderate to Severe Asthma
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
SkyePharma AG
Age
12–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Ages eligible for study: 12 years and above; genders eligible for study: both; prior steroid use: steroid-requiring
History of asthma for at least 12 months.
Documented use of inhaled corticosteroid for at least 4 weeks prior to Screening Visit Demonstrate FEV-1 of 40-80% of predicted normal values at Screening and Baseline Visit.
Documented reversibility of 15% within 12 months of Screening visit 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.
You may not be if
Life-threatening asthma within past year or during Run-In Period.
History of systemic corticosteroid medication within 3 months before 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
