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

• ClinicalTrials.gov Identifier: NCT00394199
• Recruitment Status: Completed
• First Posted: October 31, 2006
• Last Update Posted: June 23, 2011
• Sponsor: SkyePharma AG
• Information provided by: SkyePharma AG

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Asthma	Drug: Fluticasone propionate/Formoterol Fumarate 100/10; Drug: Fluticasone propionate 100; Drug: Formoterol fumarate 10	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 357 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-blind, Active-controlled, Parallel Group, 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 Fluticasone (100 µg Twice Daily) and Formoterol (10 µg Twice Daily) Alone in Adolescent & Adult Patients With Mild to Moderate Asthma
• Study Start Date: June 2006
• Actual Primary Completion Date: February 2008
• Actual Study Completion Date: February 2008

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1; FlutiForm 100/10ug	Drug: Fluticasone propionate/Formoterol Fumarate 100/10; FlutiForm 100/10ug is a HFA pMDI that delivers 50ug of Fluticasone propionate per actuation and 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 12 weeks.; Other Name: Flutiform 100/10
Experimental: 2; Fluticasone 100	Drug: Fluticasone propionate 100; Fluticasone 100 is a HFA pMDI that delivers 50ug of Fluticasone propionate per actuation. Patients will take 2 actuations BID for 12 weeks.; Other Name: Fluticasone 100
Active Comparator: 3; Formoterol 10	Drug: Formoterol fumarate 10; Formoterol 10ug is a HFA pMDI that delivers 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 12 weeks.; Other Name: SKP Formoterol 10

Outcome Measures

Primary Outcome Measures :

1. Change in Forced Expiratory volume in 1 s (FEV-1) from morning predose at Baseline (Week 0) to predose at Week 12 [ Time Frame: Week 0 and 12 ]

Secondary Outcome Measures :

1. Other pulmonary function tests including forced vital capacity (FVC) and peak expiratory flow rate (PEFR). [ Time Frame: Whole duration of study ]
2. Clinical endpoints (frequency of asthma exacerbations and patient data captured in diary including daily morning and evening PEFR). [ Time Frame: Whole duration of study ]
3. Safety variables include adverse events, ECGs, clinical laboratory tests and vital signs. [ Time Frame: Whole duration of study ]

Eligibility Criteria

• Ages Eligible for Study: 12 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 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.

Contacts and Locations

  Show 41 Study Locations

Sponsors and Collaborators

SkyePharma AG

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Pearlman DS, LaForce CF, Kaiser K. Fluticasone/Formoterol combination therapy compared with monotherapy in adolescent and adult patients with mild to moderate asthma. Clin Ther. 2013 Jul;35(7):950-66. doi: 10.1016/j.clinthera.2013.05.012.

• Responsible Party: SkyePharma AG
• ClinicalTrials.gov Identifier: NCT00394199 History of Changes
• Other Study ID Numbers: SKY2028-3-002
• First Posted: October 31, 2006
• Last Update Posted: June 23, 2011
• Last Verified: June 2011

Keywords provided by SkyePharma AG:

Asthma; Fluticasone Propionate; formoterol fumarate; Pressurized metered dose inhaler; Hydrofluoroalkane; Mild to Moderate Asthma

Additional relevant MeSH terms:

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Fluticasone; Formoterol Fumarate; Anti-Inflammatory Agents; Bronchodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Asthmatic Agents; Respiratory System Agents; Dermatologic Agents; Anti-Allergic Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action