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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00394199
Recruitment Status : Completed
First Posted : October 31, 2006
Last Update Posted : June 23, 2011
Sponsor:
Information provided by:
SkyePharma AG

Tracking Information
First Submitted Date  ICMJE October 27, 2006
First Posted Date  ICMJE October 31, 2006
Last Update Posted Date June 23, 2011
Study Start Date  ICMJE June 2006
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 8, 2011)
Change in Forced Expiratory volume in 1 s (FEV-1) from morning predose at Baseline (Week 0) to predose at Week 12 [ Time Frame: Week 0 and 12 ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 30, 2006)
Change in Forced Expiratory volume in 1 s (FEV-1) over 12 weeks recorded in electronic diary
Change History Complete list of historical versions of study NCT00394199 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2011)
  • Other pulmonary function tests including forced vital capacity (FVC) and peak expiratory flow rate (PEFR). [ Time Frame: Whole duration of study ]
  • Clinical endpoints (frequency of asthma exacerbations and patient data captured in diary including daily morning and evening PEFR). [ Time Frame: Whole duration of study ]
  • Safety variables include adverse events, ECGs, clinical laboratory tests and vital signs. [ Time Frame: Whole duration of study ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2006)
  • Other pulmonary function tests including forced vital capacity (FVC) and peak expiratory flow rate (PEFR).
  • Clinical endpoints (frequency of asthma exacerbations and patient data captured in diary including daily morning and evening PEFR).
  • Safety variables include adverse events, ECGs, clinical laboratory tests and vital signs.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of New Combination Inhaler (FlutiForm HFA MDI 100/10 µg) Versus Fluticasone & Formoterol Administered Alone in Patients With Asthma
Official Title  ICMJE A Randomized, Double-blind, Active-controlled, Parallel Group, 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 Fluticasone (100 µg Twice Daily) and Formoterol (10 µg Twice Daily) Alone in Adolescent & Adult Patients With Mild to Moderate Asthma
Brief Summary 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, in adult and adolescent patients with mild to moderate asthma.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • 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
  • Drug: Fluticasone propionate 100
    Fluticasone 100 is a HFA pMDI that delivers 50ug of Fluticasone propionate per actuation. Patients will take 2 actuations BID for 12 weeks.
    Other Name: Fluticasone 100
  • 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
Study Arms  ICMJE
  • Experimental: 1
    FlutiForm 100/10ug
    Intervention: Drug: Fluticasone propionate/Formoterol Fumarate 100/10
  • Experimental: 2
    Fluticasone 100
    Intervention: Drug: Fluticasone propionate 100
  • Active Comparator: 3
    Formoterol 10
    Intervention: Drug: Formoterol fumarate 10
Publications * Pearlman DS, LaForce CF, Kaiser K. Fluticasone/Formoterol combination therapy compared with monotherapy in adolescent and adult patients with mild to moderate asthma. Clin Ther. 2013 Jul;35(7):950-66. doi: 10.1016/j.clinthera.2013.05.012.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 8, 2011)
357
Original Enrollment  ICMJE
 (submitted: October 30, 2006)
350
Actual Study Completion Date  ICMJE February 2008
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • 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 steriod-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:

Patients will not be eligible for the study if they meet any of the following criteria:

  • Life-threatening asthma within the past year or during the Run-In Period.
  • History of systemic corticosteroid medication within 3 months before the 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00394199
Other Study ID Numbers  ICMJE SKY2028-3-002
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party SkyePharma AG
Study Sponsor  ICMJE SkyePharma AG
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account SkyePharma AG
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP