New Combination Inhaler (FlutiForm HFA MDI 100/10 µg and 250/10 µg) in Patients With Asthma

SkyePharma

Status and phase

Completed

Phase 3

Conditions

Asthma

Treatments

Drug: Fluticasone propionate/formoterol fumarate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00394121

SKY2028-3-003

Details and patient eligibility

About

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.

Enrollment

400 estimated patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.