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

Phase 3

Completed

Interventions: Drug: Fluticasone propionate 100
Drug: Fluticasone propionate/Formoterol Fumarate 100/10
Drug: Formoterol fumarate 10

Brief Summary: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
2	Fluticasone propionate 100	Fluticasone 100
1	Fluticasone propionate/Formoterol Fumarate 100/10	FlutiForm 100/10ug
3	Formoterol fumarate 10	Formoterol 10

Primary Outcome Measures

Name	Time	Method
Change in Forced Expiratory volume in 1 s (FEV-1) from morning predose at Baseline (Week 0) to predose at Week 12	Week 0 and 12

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 include adverse events, ECGs, clinical laboratory tests and vital signs.	Whole duration of study