New Combination Inhaler (FlutiForm HFA MDI 100/10 µg and 250/10 µg) Versus Fluticasone and Formoterol Administered Alone, and Placebo in Patients With Moderate to Severe Asthma

This study has been completed.
Sponsor:
Information provided by:
SkyePharma AG
ClinicalTrials.gov Identifier:
NCT00393952
First received: October 27, 2006
Last updated: June 8, 2011
Last verified: June 2011
  Purpose

The purpose of this study is to compare the efficacy and safety of the fixed combination asthma drug FlutiForm with its two components administered alone, fluticasone propionate and formoterol fumarate, and with placebo in adult and adolescent patients with moderate to severe asthma.


Condition Intervention Phase
Asthma
Drug: Fluticasone propionate/Formoterol fumarate 250/10
Drug: Placebo
Drug: Fluticasone propionate/Formoterol fumarate 100/10
Drug: Fluticasone propionate 250
Drug: Formoterol fumarate 10
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Parallel Group, Stratified, Multi-center, 12-Week Study Comparing the Safety and Efficacy of Fluticasone and Formoterol Combination (FlutiForm(tm) 100/10 µg or 250/10 µg Twice Daily) in a Single Inhaler (SkyePharma HFA pMDI) With the Administration of Placebo or Fluticasone (250 µg Twice Daily) and Formoterol (10 µg Twice Daily) Alone in Adolescent and Adult Patients With Moderate to Severe Asthma

Resource links provided by NLM:


Further study details as provided by SkyePharma AG:

Primary Outcome Measures:
  • Change in Forced Expiratory Volume in 1 s(FEV-1) from Baseline (Week 0) to Week 12. [ Time Frame: Week 0 and 12 visits ] [ Designated as safety issue: No ]
  • Discontinuation due to lack of efficacy. [ Time Frame: Whole duration of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Other pulmonary function tests including forced vial capacity (FVC) and peak expiratory flow rate (PEFR). [ Time Frame: Whole duration of study ] [ Designated as safety issue: No ]
  • Clinical endpoints (frequency of asthma exacerbations and patient data captured in diary including daily morning and evening PEFR). [ Time Frame: Whole duration of study ] [ Designated as safety issue: No ]
  • Serial 12-hour FEV-1 area under the curve (AUC). [ Time Frame: Week 0, 2 and 12 visits ] [ Designated as safety issue: No ]
  • Safety variables including adverse events, ECGs clinical laboratory tests and vital signs. [ Time Frame: Whole duration of study ] [ Designated as safety issue: Yes ]

Enrollment: 557
Study Start Date: June 2006
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
FlutiForm 250/10
Drug: Fluticasone propionate/Formoterol fumarate 250/10
FlutiForm 250/10ug is a HFA pMDI that delivers 125ug of Fluticasone propionate per actuation and 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 12 weeks.
Other Name: FlutiForm 250/10
Active Comparator: 2
FlutiForm 100/10
Drug: Fluticasone propionate/Formoterol fumarate 100/10
FlutiForm 100/10ug is a HFA pMDI that delivers 50ug of Fluticasone propionate per actuation and 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 12 weeks.
Other Name: FlutiForm 100/10
Active Comparator: 3
Fluticasone 250
Drug: Fluticasone propionate 250
Fluticasone 250 is a HFA pMDI that delivers 125ug of Fluticasone propionate per actuation. Patients will take 2 actuations BID for 12 weeks.
Other Name: Fluticasone 250
Active Comparator: 4
Formoterol 10
Drug: Formoterol fumarate 10
Formoterol 10ug is a HFA pMDI that delivers 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 12 weeks.
Other Name: SKP Formoterol 10
Placebo Comparator: 5
Placebo
Drug: Placebo
Placebo is a HFA pMDI that delivers placebo aerosol. Patients will take 2 actuations BID for 12 weeks.
Other Name: SKP Placebo

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 corticosteroid 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 12 months of Screening visit or at Screening Visit (15% increase from pre-FEV-1 levels following albuterol inhalation or nebulized albuterol administration).
  • 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 past 6 months.
  • History of leukotriene receptor antagonist use, e.g. montelukast, within past week.
  • Current evidence or 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.
  • Current evidence or history of alcohol and/or substance abuse within 12 months prior to Screening visit.
  • Patients who are confined in institution.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00393952

  Show 63 Study Locations
Sponsors and Collaborators
SkyePharma AG
  More Information

No publications provided

Responsible Party: Skyepharma AG
ClinicalTrials.gov Identifier: NCT00393952     History of Changes
Other Study ID Numbers: SKY2028-3-004
Study First Received: October 27, 2006
Last Updated: June 8, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by SkyePharma AG:
Asthma
Fluticasone Propionate
Formoterol Fumarate
Pressurized metered dose inhaler
Hydrofluoroalkane
Moderate-Severe Asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Formoterol
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014