Asthma
Conditions
Keywords
Asthma, Fluticasone Propionate, Formoterol Fumarate, Pressurized metered dose inhaler, Hydrofluoroalkane, Mild to Moderate Asthma
Brief summary
The purpose of this study is to compare the efficacy and safety of the fixed combination asthma drug FlutiForm HFA MDI with its two components administered alone, fluticasone propionate and formoterol fumarate, and with placebo in adult and adolescent patients with mild to moderate asthma.
Interventions
FlutiForm 100/10ug is a HFA pMDI that delivers 50ug of Fluticasone propionate per actuation and 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 12 weeks.
Fluticasone 100ug is a HFA pMDI that delivers 50ug of Fluticasone propionate per actuation. Patients will take 2 actuations BID for 12 weeks.
Formoterol 10ug is a HFA pMDI that delivers 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 12 weeks.
DRUGPlacebo
Placebo is a HFA pMDI that delivers placebo aerosol. Patients will take 2 actuations BID for 12 weeks.
Sponsors
SkyePharma AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
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 or steroid-free. Inclusion Criteria: * 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.
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Forced Expiratory Volume in 1 s (FEV-1) over 12 weeks recorded in electronic diary. Discontinuation due to lack of efficacy | Week 0 and 12 visits |
Secondary
| Measure | Time frame |
|---|---|
| Other pulmonary function tests including forced vital capacity (FVC) and peak expiratory flow rate (PEFR). | Whole duration of study |
| Clinical endpoints (frequency of asthma exacerbations and patient data captured in diary including daily morning and evening PEFR). | Whole duration of study |
| Safety variables including adverse events, ECGs, clinical laboratory tests and vital signs. | Whole duration of study |
| Serial 12-hour FEV-1 area under the curve (AUC). | Week 0, 2 and 12 visits |
Countries
Canada, United States
Outcome results
None listed