New Combination Inhaler (FlutiForm HFA MDI 100/10 µg and 250/10 µg) Versus Fluticasone and Formoterol Administered Alone, and Placebo in Patients With Moderate to Severe Asthma

Completed · Phase 3 · Has a placebo group

Conditions studied: Asthma

In brief

The purpose of this study is to compare the efficacy and safety of the fixed combination asthma drug FlutiForm with its two components administered alone, fluticasone propionate and formoterol fumarate, and with placebo in adult and adolescent patients with moderate to severe asthma.

Key facts

Study ID

NCT00393952

Run by

SkyePharma AG

People needed

557

Starts

2006-06-01

Expected to finish

2008-04-01

Last updated by the study team

2011-06-23

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• History of asthma for at least 12 months.
• Documented use of inhaled corticosteroid 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 12 months of Screening visit 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 qualify if…

• 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.

Where it is running

• Research Site — Glendale, Arizona, United States
• Research Center — Phoenix, Arizona, United States
• Research Site — Phoenix, Arizona, United States
• Research Site — Tucson, Arizona, United States
• Research Site — Jonesboro, Arkansas, United States
• Research Site — Little Rock, Arkansas, United States
• Research Site — Burbank, California, United States
• Research Site — Fresno, California, United States
• Research Site — Long Beach, California, United States
• Research Site — Los Angeles, California, United States
• Research Center — Los Angeles, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Mission Viejo, California, United States
• Research Site — Monterey Park, California, United States
• Research Site — Palmdale, California, United States
• Research Site — Sacramento, California, United States
• Research Site — San Diego, California, United States
• Research Site — San Diego, California, United States
• Research Site — San Jose, California, United States
• Research Center — Gainesville, Florida, United States
• Research Site — Hialeah, Florida, United States
• Research Site — Ormond Beach, Florida, United States
• Research Center — Panama City, Florida, United States
• Research Site — Pensacola, Florida, United States
• Research Center — Pell City, Alabama, United States

Full record on ClinicalTrials.gov

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