New Combination Inhaler (FlutiForm HFA MDI 100/10 µg and 250/10 µg) in Patients With Asthma
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
1 other identifier
interventional
400
5 countries
28
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 asthma
Started Mar 2006
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 27, 2006
CompletedFirst Posted
Study publicly available on registry
October 31, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedAugust 27, 2010
August 1, 2010
1.3 years
October 27, 2006
August 24, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Long-term safety after twice daily treatment with FlutiForm HFA MDI over 12 months.
Secondary Outcomes (1)
Long-term efficacy after twice daily treatment with FlutiForm HFA MDI over 12 months.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SkyePharma AGlead
Study Sites (28)
Research Site
Berlin, Germany
Research Site
Hamburg, Germany
Research Site
Mainz, Germany
Research Site
Rüdersdorf, Germany
Research Site
Solingen, Germany
Research Site
Budapest, Hungary
Research Site
Deszk, Hungary
Research Site
Kecskemét, Hungary
Research Site
Miskolc, Hungary
Research Site
Mosonmagyaróvár, Hungary
Research Site
Bialystok, Poland
Research Site
Gdansk, Poland
Research Site
Krakow, Poland
Research Site
Lodz, Poland
Research Site
Wroclaw, Poland
Research Site
Bucharest, Romania
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
Related Publications (1)
Mansur AH, Kaiser K. Long-term safety and efficacy of fluticasone/formoterol combination therapy in asthma. J Aerosol Med Pulm Drug Deliv. 2013 Aug;26(4):190-9. doi: 10.1089/jamp.2012.0977. Epub 2012 Oct 25.
PMID: 23098325DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 27, 2006
First Posted
October 31, 2006
Study Start
March 1, 2006
Primary Completion
July 1, 2007
Study Completion
July 1, 2007
Last Updated
August 27, 2010
Record last verified: 2010-08