Clinical trial NCT00394121: New Combination Inhaler (FlutiForm HFA MDI 100/10 µg and 250/10 µg) in Patients With Asthma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma
Fluticasone Propionate
Formoterol Fumarate
Pressurized metered does inhaler
Hydrofluoroalkane
Mild to moderate-severe asthma
Lead sponsor: SkyePharma AG
Sponsor class: INDUSTRY
First posted: 2006-10-31
Enrollment: 400
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Long-term safety after twice daily treatment with FlutiForm HFA MDI over 12 months.
Secondary outcomes:
measure: Long-term efficacy after twice daily treatment with FlutiForm HFA MDI over 12 months.
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Mainz
country: Germany
facility: Research Site
city: Rudersdorf
country: Germany
facility: Research Site
city: Solingen
country: Germany
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Deszk
country: Hungary
facility: Research Site
city: Kecskemet
country: Hungary
facility: Research Site
city: Miskolc
country: Hungary
facility: Research Site
city: Mosonmagyarovar
country: Hungary
facility: Research Site
city: Bialystok
country: Poland
facility: Research Site
city: Gdansk
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
city: Bucharest
country: Romania
facility: Research Site
city: Birmingham
country: United Kingdom
facility: Research Site
city: Carrickfergus
country: United Kingdom
facility: Research Site
city: Chippenham
country: United Kingdom
facility: Research Site
city: Cottingham
country: United Kingdom
facility: Research Site
city: Coventry
country: United Kingdom
facility: Research Site
city: Downpatrick
country: United Kingdom
facility: Research Site
city: Heywood
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Sheffield
country: United Kingdom
facility: Research Site
city: Solihull
country: United Kingdom
facility: Research Site
city: Sunbury on Thames
country: United Kingdom
facility: Research Site
city: Swindon Wilts
country: United Kingdom
facility: Research Site
Study officials:
References:
citation: 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.