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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00394199
Recruitment Status : Completed
First Posted : October 31, 2006
Last Update Posted : June 23, 2011
Information provided by:
SkyePharma AG

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

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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

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

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 ]

Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00394199

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Sponsors and Collaborators
SkyePharma AG

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: SkyePharma AG Identifier: NCT00394199    
Other Study ID Numbers: SKY2028-3-002
First Posted: October 31, 2006    Key Record Dates
Last Update Posted: June 23, 2011
Last Verified: June 2011
Keywords provided by SkyePharma AG:
Fluticasone Propionate
formoterol fumarate
Pressurized metered dose inhaler
Mild to Moderate Asthma
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
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