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New Combination Inhaler (FlutiForm HFA MDI 100/10 µg and 250/10 µg) in Patients With Asthma

This study has been completed.

Sponsored by: SkyePharma AG
Information provided by: SkyePharma AG
ClinicalTrials.gov Identifier: NCT00394121
  Purpose

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 Intervention Phase
Asthma
Drug: Fluticasone propionate/formoterol fumarate
Phase III

MedlinePlus related topics:   Asthma   

ChemIDplus related topics:   Fluticasone propionate    Fluticasone    Formoterol    Arformoterol    Arformoterol Tartrate    Formoterol fumarate    HFA 227   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study
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

Further study details as provided by SkyePharma AG:

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

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

Estimated Enrollment:   400
Study Start Date:   March 2006
Study Completion Date:   February 2008

  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 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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00394121

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

Sponsors and Collaborators
SkyePharma AG
  More Information


Study ID Numbers:   SKY2028-3-003
First Received:   October 27, 2006
Last Updated:   May 27, 2008
ClinicalTrials.gov Identifier:   NCT00394121
Health Authority:   United States: Food and Drug Administration;   Germany: Federal Institute for Drugs and Medical Devices;   Hungary: National Institute of Pharmacy;   Poland: Ministry of Health;   Romania: National Medicines Agency;   United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

Study placed in the following topic categories:
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate
Formoterol
Fluticasone
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Bronchial Diseases
Immune System Diseases
Adrenergic beta-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Asthmatic Agents
Anti-Allergic Agents
Adrenergic Agonists
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Dermatologic Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on September 23, 2008




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