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New Combination Inhaler (FlutiForm HFA MDI 100/10 µg and 250/10 µg) 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.
ClinicalTrials.gov Identifier: NCT00394121
Recruitment Status : Completed
First Posted : October 31, 2006
Last Update Posted : August 27, 2010
Information provided by:
SkyePharma AG

Brief Summary:
The purpose of this study is to evaluate the long-term safety of the fixed combination asthma drug FlutiForm HFA MDI (containing fluticasone propionate and formoterol fumarate) in adult and adolescent patients with mild to moderate-severe asthma.

Condition or disease Intervention/treatment Phase
Asthma Drug: Fluticasone propionate/formoterol fumarate Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long-term Open-label Safety Study With SkyePharma FlutiForm HFA pMDI (100/10 µg and 250/10 µg) in Adult and Adolescent Patients With Asthma
Study Start Date : March 2006
Primary Completion Date : July 2007
Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Primary Outcome Measures :
  1. Long-term safety after twice daily treatment with FlutiForm HFA MDI over 12 months.

Secondary Outcome Measures :
  1. Long-term efficacy after twice daily treatment with FlutiForm HFA MDI over 12 months.

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
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.

Inclusion Criteria:

  • History of asthma for at least 12 months.
  • Documented use of inhaled corticosteriod 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 6 months of Screening Visit or at Screening Visit (15% increase from pre-FEV-1 levels following albuterol inhalation).
  • 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 the past 6 months.
  • History of leukotriene receptor antagonist use, e.g., montelukast, within the past week.
  • Current evidence of 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.

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 ClinicalTrials.gov identifier (NCT number): NCT00394121

Research Site
Berlin, Germany
Research Site
Hamburg, Germany
Research Site
Mainz, Germany
Research Site
Rudersdorf, Germany
Research Site
Solingen, Germany
Research Site
Budapest, Hungary
Research Site
Deszk, Hungary
Research Site
Kecskemet, Hungary
Research Site
Miskolc, Hungary
Research Site
Mosonmagyarovar, Hungary
Research Site
Bialystok, Poland
Research Site
Gdansk, Poland
Research Site
Krakow, Poland
Research Site
Lodz, Poland
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Wroclaw, Poland
Research Site
Bucharest, Romania
United Kingdom
Research Site
Birmingham, United Kingdom
Research Site
Carrickfergus, United Kingdom
Research Site
Chippenham, United Kingdom
Research Site
Cottingham, United Kingdom
Research Site
Coventry, United Kingdom
Research Site
Downpatrick, United Kingdom
Research Site
Heywood, United Kingdom
Research Site
Manchester, United Kingdom
Research Site
Sheffield, United Kingdom
Research Site
Solihull, United Kingdom
Research Site
Sunbury on Thames, United Kingdom
Research Site
Swindon Wilts, United Kingdom
Sponsors and Collaborators
SkyePharma AG

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00394121     History of Changes
Other Study ID Numbers: SKY2028-3-003
First Posted: October 31, 2006    Key Record Dates
Last Update Posted: August 27, 2010
Last Verified: August 2010

Keywords provided by SkyePharma AG:
Fluticasone Propionate
Formoterol Fumarate
Pressurized metered does inhaler
Mild to moderate-severe asthma

Additional relevant MeSH terms:
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