New Combination Inhaler (FlutiForm HFA MDI 100/10 µg and 250/10 µg) in Patients With Asthma
This study is currently recruiting patients.
Verified by SkyePharma October 2006
| Sponsored by: |
SkyePharma |
| Information provided by: |
SkyePharma |
| 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
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:
Primary Outcomes: Long-term safety after twice daily treatment with FlutiForm HFA MDI over 12 months.
Secondary Outcomes: Long-term efficacy after twice daily treatment with FlutiForm HFA MDI over 12 months.
Expected Total Enrollment: 400
Study start: March 2006; Expected completion: September 2007
Last follow-up: June 2007; Data entry closure: August 2007
Eligibility
Ages Eligible for Study: 12 Years and above, Genders Eligible for Study: Both
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.
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00394121
Germany
Research Site, Hamburg, Germany; Recruiting
Research Site, Berlin, Germany; Recruiting
Research Site, Mainz, Germany; Recruiting
Research Site, Rudersdorf, Germany; Recruiting
Research Site, Solingen, Germany; Recruiting
Hungary
Research Site, Deszk, Hungary; Recruiting
Research Site, Miskolc, Hungary; Recruiting
Research Site, Mosonmagyarovar, Hungary; Recruiting
Research Site, Kecskemet, Hungary; Recruiting
Research Site, Budapest, Hungary; Recruiting
Poland
Research Site, Bialystok, Poland; Recruiting
Research Site, Lodz, Poland; Recruiting
Research Site, Gdansk, Poland; Recruiting
Research Site, Krakow, Poland; Recruiting
Research Site, Wroclaw, Poland; Recruiting
Romania
Research Site, Bucharest, Romania; Recruiting
United Kingdom
Research Site, Birmingham, United Kingdom; Recruiting
Research Site, Solihull, United Kingdom; Recruiting
Research Site, Downpatrick, United Kingdom; Recruiting
Research Site, Swindon Wilts, United Kingdom; Recruiting
Research Site, Coventry, United Kingdom; Recruiting
Research Site, Carrickfergus, United Kingdom; Recruiting
Research Site, Heywood, United Kingdom; Recruiting
Research Site, Sheffield, United Kingdom; Recruiting
Research Site, Chippenham, United Kingdom; Recruiting
Research Site, Manchester, United Kingdom; Recruiting
Research Site, Sunbury on Thames, United Kingdom; Recruiting
Research Site, Cottingham, United Kingdom; Recruiting
More Information
Study ID Numbers: SKY2028-3-003
Last Updated: October 30, 2006
Record first received: October 27, 2006
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
