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

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ClinicalTrials.gov Identifier: NCT00393991
Recruitment Status : Completed
First Posted : October 31, 2006
Last Update Posted : June 23, 2011
Sponsor:
Information provided by:
SkyePharma AG

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

Condition or disease Intervention/treatment Phase
Asthma Drug: Fluticasone propionate/formoterol fumarate 100/10 Drug: Fluticasone propionate 100 Drug: Formoterol fumarate 10 Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 475 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Parallel, Stratified, Multi-center, 12-Week Study Comparing the Safety & Efficacy of Fluticasone and Formoterol Combination (FlutiForm(tm)100/10 µg Twice Daily) in a Single Inhaler (SkyePharma HFA pMDI)With the Administration of Placebo or Fluticasone (100 µg Twice Daily) and Formoterol (10 µg Twice Daily) Alone in Adolescent and Adult Patients With Mild to Moderate Asthma
Study Start Date : July 2006
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008


Arm Intervention/treatment
Experimental: 1
FlutiForm 100/10 μg
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: 2
Fluticasone 100 μg
Drug: Fluticasone propionate 100
Fluticasone 100ug is a HFA pMDI that delivers 50ug of Fluticasone propionate per actuation. Patients will take 2 actuations BID for 12 weeks.
Other Name: SKP Fluticasone 100

Active Comparator: 3
Formoterol 10 μg
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: 4
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




Primary Outcome Measures :
  1. Change in Forced Expiratory Volume in 1 s (FEV-1) over 12 weeks recorded in electronic diary. Discontinuation due to lack of efficacy [ Time Frame: Week 0 and 12 visits ]

Secondary Outcome Measures :
  1. Other pulmonary function tests including forced vital capacity (FVC) and peak expiratory flow rate (PEFR). [ Time Frame: Whole duration of study ]
  2. Clinical endpoints (frequency of asthma exacerbations and patient data captured in diary including daily morning and evening PEFR). [ Time Frame: Whole duration of study ]
  3. Safety variables including adverse events, ECGs, clinical laboratory tests and vital signs. [ Time Frame: Whole duration of study ]
  4. Serial 12-hour FEV-1 area under the curve (AUC). [ Time Frame: Week 0, 2 and 12 visits ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Ages eligible for study: 12 years and above; genders eligible for study: both; prior steroid use: steroid-requiring or steroid-free.

Inclusion Criteria:

  • History of asthma for at least 12 months.
  • For steroid-requiring patients, documented use of inhaled corticosteroid for at least 4 weeks prior to Screening Visit
  • For steroid-free patients, no history of inhaled steroid asthma medication for at least 12 weeks prior to Screening Visit.
  • Demonstrate FEV-1 of 60-85% of predicted normal values at Screening and Baseline Visit.
  • Documented reversibility of 15% within 12 months of Screening 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00393991


Locations
Show Show 57 study locations
Sponsors and Collaborators
SkyePharma AG
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: SkyePharma AG
ClinicalTrials.gov Identifier: NCT00393991    
Other Study ID Numbers: SKY2028-3-001
First Posted: October 31, 2006    Key Record Dates
Last Update Posted: June 23, 2011
Last Verified: June 2011
Keywords provided by SkyePharma AG:
Asthma
Fluticasone Propionate
Formoterol Fumarate
Pressurized metered dose inhaler
Hydrofluoroalkane
Mild to Moderate Asthma
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Formoterol Fumarate
Anti-Inflammatory Agents
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