Status:
COMPLETED
Comparison of New Combination Inhaler (FlutiForm HFA MDI 100/10 µg) Versus Fluticasone & Formoterol Administered Alone in Patients With Asthma
Lead Sponsor:
SkyePharma AG
Conditions:
Asthma
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
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, in adult and adole...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
357 Patients enrolled
Trial Details
Trial ID
NCT00394199
Start Date
June 1 2006
End Date
February 1 2008
Last Update
June 23 2011
Active Locations (41)
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1
Research Site
Birmingham, Alabama, United States, 35242
2
Research Site
Mission Viejo, California, United States, 92691
3
Research Site
Orange, California, United States, 92868
4
Research Site
San Jose, California, United States, 95117