New Combination Inhaler (Flutiform HFA MDI 100/10 µg and 250/10 µg) Versus Fluticasone and Formoterol Administered Alone, and Placebo in Patients With Moderate to Severe Asthma - Full Text View

Sponsor:	SkyePharma AG
Information provided by:	SkyePharma AG
ClinicalTrials.gov Identifier:	NCT00393952

Purpose

The purpose of this study is to compare the efficacy and safety of the fixed combination asthma drug Flutiform with its two components administered alone, fluticasone propionate and formoterol fumarate, and with placebo in adult and adolescent patients with moderate to severe asthma.

Condition	Intervention	Phase
Asthma	Drug: Fluticasone propionate/Formoterol fumarate Other: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Stratified, Multi-Center, 12-Week Study Comparing the Safety and Efficacy of Fluticasone and Formoterol Combination (FlutiForm(tm) 100/10 µg or 250/10 µg Twice Daily) in a Single Inhaler (SkyePharma HFA pMDI) With the Administration of Placebo or Fluticasone (250 µg Twice Daily) and Formoterol (10 µg Twice Daily) Alone in Adolescent and Adult Patients With Moderate to Severe Asthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Formoterol fumarate Arformoterol Formoterol Fluticasone propionate Fluticasone Arformoterol Tartrate

U.S. FDA Resources

Further study details as provided by SkyePharma AG:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Other pulmonary function tests including forced vial capacity (FVC) and peak expiratory flow rate (PEFR).
Clinical endpoints (frequency of asthma exacerbations and patient data captured in diary including daily morning and evening PEFR).
Serial FEV-1 area under the curve (AUC).
Safety variable including adverse events, ECGs clinical laboratory tests and vital signs.

Enrollment:	556
Study Start Date:	June 2006
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Ages eligible for study: 12 years and above; genders eligible for study: both; prior steroid use: steroid-requiring

Inclusion Criteria:

History of asthma for at least 12 months.
Documented use of inhaled corticosteroid for at least 4 weeks prior to Screening Visit Demonstrate FEV-1 of 40-80% of predicted normal values at Screening and Baseline Visit.
Documented reversibility of 15% within 12 months of Screening visit 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00393952

Show 63 Study Locations

Sponsors and Collaborators

SkyePharma AG

More Information

No publications provided

Study ID Numbers:	SKY2028-3-004
Study First Received:	October 27, 2006
Last Updated:	June 23, 2008
ClinicalTrials.gov Identifier:	NCT00393952 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by SkyePharma AG:

Asthma
Fluticasone Propionate
Formoterol Fumarate

Pressurized metered dose inhaler
Hydrofluoroalkane
Moderate-Severe Asthma

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Bronchial Diseases
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic Agonists
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Therapeutic Uses
Fluticasone
Formoterol

Dermatologic Agents
Adrenergic beta-Agonists
Immune System Diseases
Asthma
Anti-Asthmatic Agents
Anti-Allergic Agents
Pharmacologic Actions
Autonomic Agents
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on February 08, 2010