Comparison of New Combination Inhaler (FlutiForm HFA MDI 100/10 µg) Versus Fluticasone & Formoterol Administered Alone in Patients With Asthma

SkyePharma

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Fluticasone propionate/Formoterol Fumarate 100/10; Drug: Formoterol fumarate 10; Drug: Fluticasone propionate 100

Study type: Interventional

Funder types: Industry

Identifiers

NCT00394199

SKY2028-3-002

Details and patient eligibility

About

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 adolescent patients with mild to moderate asthma.

Enrollment: 357 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 or steroid-free

Inclusion Criteria:

• 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 Criteria:

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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357 participants in 3 patient groups

1

Experimental group

Description:

FlutiForm 100/10ug

Treatment:

Drug: Fluticasone propionate/Formoterol Fumarate 100/10

2

Experimental group

Description:

Fluticasone 100

Treatment:

Drug: Fluticasone propionate 100

3

Active Comparator group

Description:

Formoterol 10

Treatment:

Drug: Formoterol fumarate 10