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

This study has been completed.
Sponsor:
Information provided by:
SkyePharma AG
ClinicalTrials.gov Identifier:
NCT00394121
First received: October 27, 2006
Last updated: August 24, 2010
Last verified: August 2010
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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: July 2007
Primary Completion Date: July 2007 (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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
Research Site
Berlin, Germany
Research Site
Hamburg, Germany
Research Site
Mainz, Germany
Research Site
Rudersdorf, Germany
Research Site
Solingen, Germany
Hungary
Research Site
Budapest, Hungary
Research Site
Deszk, Hungary
Research Site
Kecskemet, Hungary
Research Site
Miskolc, Hungary
Research Site
Mosonmagyarovar, Hungary
Poland
Research Site
Bialystok, Poland
Research Site
Gdansk, Poland
Research Site
Krakow, Poland
Research Site
Lodz, Poland
Research Site
Wroclaw, Poland
Romania
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
  More Information

No publications provided by SkyePharma AG

Additional 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
Study First Received: October 27, 2006
Last Updated: August 24, 2010
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

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
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on September 22, 2014