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

Phase 3

Completed

Interventions: Drug: Fluticasone propionate/formoterol fumarate 100/10
Drug: Fluticasone propionate 100
Drug: Formoterol fumarate 10
Drug: Placebo

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
1	Fluticasone propionate/formoterol fumarate 100/10	FlutiForm 100/10 μg
2	Fluticasone propionate 100	Fluticasone 100 μg
3	Formoterol fumarate 10	Formoterol 10 μg
4	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Change in Forced Expiratory Volume in 1 s (FEV-1) over 12 weeks recorded in electronic diary. Discontinuation due to lack of efficacy	Week 0 and 12 visits

Secondary Outcome Measures

Name	Time	Method
Other pulmonary function tests including forced vital capacity (FVC) and peak expiratory flow rate (PEFR).	Whole duration of study
Clinical endpoints (frequency of asthma exacerbations and patient data captured in diary including daily morning and evening PEFR).	Whole duration of study
Safety variables including adverse events, ECGs, clinical laboratory tests and vital signs.	Whole duration of study
Serial 12-hour FEV-1 area under the curve (AUC).	Week 0, 2 and 12 visits