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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00394121
• Other study ID #: SKY2028-3-003
• Status: Completed
• Phase: Phase 3
• First received: October 27, 2006
• Last updated: August 24, 2010
• Start date: March 2006
• Est. completion date: July 2007

Study information

• Verified date: August 2010
• Source: SkyePharma AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of PharmacyPoland: Ministry of HealthRomania: National Medicines AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Fluticasone propionate/formoterol fumarate

Locations

Country	Name	City	State
Germany	Research Site	Berlin
Germany	Research Site	Hamburg
Germany	Research Site	Mainz
Germany	Research Site	Rudersdorf
Germany	Research Site	Solingen
Hungary	Research Site	Budapest
Hungary	Research Site	Deszk
Hungary	Research Site	Kecskemet
Hungary	Research Site	Miskolc
Hungary	Research Site	Mosonmagyarovar
Poland	Research Site	Bialystok
Poland	Research Site	Gdansk
Poland	Research Site	Krakow
Poland	Research Site	Lodz
Poland	Research Site	Wroclaw
Romania	Research Site	Bucharest
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

Sponsors (1)

Lead Sponsor	Collaborator
SkyePharma AG

Countries where clinical trial is conducted

Germany,  Hungary,  Poland,  Romania,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long-term safety after twice daily treatment with FlutiForm HFA MDI over 12 months.
Secondary	Long-term efficacy after twice daily treatment with FlutiForm HFA MDI over 12 months.