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

Sponsor

SkyePharma AG (Industry)

Overall Status

Completed

CT.gov ID

NCT00394121

Collaborator

(none)

400

Enrollment

Locations

Duration (Months)

14.3

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: Fluticasone propionate/formoterol fumarate	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Mar 1, 2006

Actual Primary Completion Date :

Jul 1, 2007

Actual Study Completion Date :

Jul 1, 2007

Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country
1	Research Site	Berlin	Germany
2	Research Site	Hamburg	Germany
3	Research Site	Mainz	Germany
4	Research Site	Rudersdorf	Germany
5	Research Site	Solingen	Germany
6	Research Site	Budapest	Hungary
7	Research Site	Deszk	Hungary
8	Research Site	Kecskemet	Hungary
9	Research Site	Miskolc	Hungary
10	Research Site	Mosonmagyarovar	Hungary
11	Research Site	Bialystok	Poland
12	Research Site	Gdansk	Poland
13	Research Site	Krakow	Poland
14	Research Site	Lodz	Poland
15	Research Site	Wroclaw	Poland
16	Research Site	Bucharest	Romania
17	Research Site	Birmingham	United Kingdom
18	Research Site	Carrickfergus	United Kingdom
19	Research Site	Chippenham	United Kingdom
20	Research Site	Cottingham	United Kingdom
21	Research Site	Coventry	United Kingdom
22	Research Site	Downpatrick	United Kingdom
23	Research Site	Heywood	United Kingdom
24	Research Site	Manchester	United Kingdom
25	Research Site	Sheffield	United Kingdom
26	Research Site	Solihull	United Kingdom
27	Research Site	Sunbury on Thames	United Kingdom
28	Research Site	Swindon Wilts	United Kingdom