Clareo Health | Comparison of New Combination Inhaler (FlutiForm HFA MDI 100/10 µg) Versus Fluticasone & Formoterol Administered Alone in Patients With 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 or steroid-free
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.
You may not be if
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.
