Status:
COMPLETED
New Combination Inhaler (FlutiForm HFA MDI 100/10 µg and 250/10 µg) in Patients With Asthma
Lead Sponsor:
SkyePharma AG
Conditions:
Asthma
Eligibility:
All Genders
12+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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 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
- 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.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2007
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00394121
Start Date
March 1 2006
End Date
July 1 2007
Last Update
August 27 2010
Active Locations (28)
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1
Research Site
Berlin, Germany
2
Research Site
Hamburg, Germany
3
Research Site
Mainz, Germany
4
Research Site
Rudersdorf, Germany