Asthma
Conditions
Keywords
Asthma, Fluticasone Propionate, Formoterol Fumarate, Pressurized metered does inhaler, Hydrofluoroalkane, Mild to moderate-severe asthma
Brief summary
The purpose of this study is to evaluate the long-term safety of the fixed combination asthma drug FlutiForm HFA MDI (containing fluticasone propionate and formoterol fumarate) in adult and adolescent patients with mild to moderate-severe asthma.
Interventions
Sponsors
SkyePharma AG
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Ages eligible for study: 12 years and above; genders eligible for study: both; prior steroid use: steroid-requiring. Inclusion Criteria: * History of asthma for at least 12 months. * Documented use of inhaled corticosteriod 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 6 months of Screening Visit or at Screening Visit (15% increase from pre-FEV-1 levels following albuterol inhalation). * 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
* 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 the past 6 months. * History of leukotriene receptor antagonist use, e.g., montelukast, within the past week. * Current evidence of 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Long-term safety after twice daily treatment with FlutiForm HFA MDI over 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Long-term efficacy after twice daily treatment with FlutiForm HFA MDI over 12 months. | — |
Countries
Germany, Hungary, Poland, Romania, United Kingdom
Outcome results
None listed