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

Phase 3

Completed

• Conditions: Asthma

• Registration Number: NCT00394121
• Lead Sponsor: SkyePharma AG

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-10-27
• Study First Submitted QC: 2006-10-30
• Study First Posted: 2006-10-31
• Primary Completion: 2007-07
• Study Completion: 2007-07
• Status Verified: 2010-08
• Disposition First Submitted: 2010-08-24
• Disposition First Submitted QC: 2010-08-24
• Last Update Submitted: 2010-08-24
• Disposition First Posted: 2010-08-27
• Last Update Posted: 2010-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Long-term safety after twice daily treatment with FlutiForm HFA MDI over 12 months.

Secondary Outcome Measures

Name	Time	Method
Long-term efficacy after twice daily treatment with FlutiForm HFA MDI over 12 months.

Trial Locations

Locations (1)

Research Site; 🇬🇧 Swindon Wilts, United Kingdom