A Randomized, Double-blind, Placebo-controlled, Parallel, Stratified, Multi-center, 12-Week Study Comparing the Safety & Efficacy of Fluticasone and Formoterol Combination (FlutiForm(tm)100/10 µg Twice Daily) in a Single Inhaler (SkyePharma HFA pMDI)With the Administration of Placebo or Fluticasone (100 µg Twice Daily) and Formoterol (10 µg Twice Daily) Alone in Adolescent and Adult Patients With Mild to Moderate Asthma

SkyePharma AG2 sites in 2 countries475 target enrollmentJuly 2006

ConditionsAsthma

InterventionsFluticasone propionate/formoterol fumarate 100/10 Fluticasone propionate 100 Formoterol fumarate 10 Placebo

DrugsFluticasone propionate/formoterol fumarate 100/10 Fluticasone propionate 100 Formoterol fumarate 10 Placebo

Overview

Phase: Phase 3
Intervention: Fluticasone propionate/formoterol fumarate 100/10
Conditions: Asthma
Sponsor: SkyePharma AG
Enrollment: 475
Locations: 2
Primary Endpoint: Change in Forced Expiratory Volume in 1 s (FEV-1) over 12 weeks recorded in electronic diary. Discontinuation due to lack of efficacy
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2006

End Date

April 2008

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

SkyePharma AG

Eligibility Criteria

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.

Arms & Interventions

1

FlutiForm 100/10 μg

Intervention: Fluticasone propionate/formoterol fumarate 100/10

2

Fluticasone 100 μg

Intervention: Fluticasone propionate 100

3

Formoterol 10 μg

Intervention: Formoterol fumarate 10

4

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Change in Forced Expiratory Volume in 1 s (FEV-1) over 12 weeks recorded in electronic diary. Discontinuation due to lack of efficacy

Time Frame: Week 0 and 12 visits

Secondary Outcomes

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)