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

SkyePharma

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Fluticasone propionate 100; Drug: Formoterol fumarate 10; Drug: Fluticasone propionate/formoterol fumarate 100/10; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00393991

SKY2028-3-001

Details and patient eligibility

About

The purpose of this study is 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, and with placebo in adult and adolescent patients with mild to moderate asthma.

Enrollment: 475 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 steroid-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:

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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475 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

FlutiForm 100/10 μg

Treatment:

Drug: Fluticasone propionate/formoterol fumarate 100/10

2

Active Comparator group

Description:

Fluticasone 100 μg

Treatment:

Drug: Fluticasone propionate 100

3

Active Comparator group

Description:

Formoterol 10 μg

Treatment:

Drug: Formoterol fumarate 10

4

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo