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Efficacy and Safety of Flutiform® pMDI in Adult Patients With Mild to Moderate-severe Reversible 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: NCT00476073
Recruitment Status : Completed
First Posted : May 21, 2007
Last Update Posted : October 24, 2018
Sponsor:
Information provided by (Responsible Party):
Mundipharma Research Limited

Tracking Information
First Submitted Date  ICMJE May 17, 2007
First Posted Date  ICMJE May 21, 2007
Last Update Posted Date October 24, 2018
Study Start Date  ICMJE April 2007
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 18, 2007)
FEV1, (Forced expiratory volume in the 1st second).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 18, 2007)
Other lung function tests, AQLQ, Safety Assessments.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Flutiform® pMDI in Adult Patients With Mild to Moderate-severe Reversible Asthma
Official Title  ICMJE Not Provided
Brief Summary Open, parallel group design. The study has a screening phase and a 12 week treatment phase. Subjects will be randomised to treatment in a 1:1 ration.
Detailed Description This is a study involving a 12 week treatment phase. During the treatment phase subjects receive FLUTIFORM® or Sertetide®. Efficacy will be assessed by lung function tests and asthma symptoms, sleep disturbance. Safety will be assessed by adverse events, vital signs, lab tests and ECGs.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Asthma Bronchiale
Intervention  ICMJE Drug: FLUTIFORM® (Formoterol fumarate / Fluticasone propionate)
Study Arms  ICMJE Not Provided
Publications *

*   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: February 8, 2016)
228
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE January 2008
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female patients at least 18 years or older (females less than one year post-menopausal must have a negative serum or urine pregnancy test recorded within 72 hours prior to the first dose of study medication, be non-lactating, and willing to use adequate and highly effective methods of contraception throughout the study. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as sterilization, implants, injectables, combined oral contraceptives, some IUDs (Intrauterine Device, hormonal), sexual abstinence or vasectomised partner).
  • Known history of mild to moderate-severe reversible asthma for > 6 months prior to the screening visit.
  • Demonstrate a FEV1 of >40% to <80% for predicted normal values (EGKS normal values, 1983) during the screening phase following appropriate withholding of asthma medications (if applicable).

    • No beta agonist use on day of screening.
    • No use of combination asthma therapy on day of screening.
    • Inhaled corticosteroids are allowed on day of screening.
  • Documented reversibility of > 15% in FEV1 in the screening phase.
  • Demonstrate satisfactory technique in the use of the pressurized MDI.
  • Willing and able to enter information in the electronic diary and attend all study visits.
  • Willing and able to substitute study medication for their pre study prescribed asthma medication for the duration of the study.
  • Written informed consent obtained.

Exclusion Criteria:

  • Life-threatening asthma within the past year. This category includes those patients with a history of near-fatal asthma, a hospitalization or an emergency visit for asthma or prior intubation for asthma.
  • History of systemic (injectable) corticosteroid medication within 1 month before the 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 or history of any clinically significant disease or abnormality including uncontrolled coronary artery disease, congestive heart failure, myocardial infarction, or cardiac dysrhythmia. 'Clinically significant' is defined as any disease that, in the opinion of the Investigator, would put the patient at risk through study participation, or which would affect the outcome of the study.
  • An upper or lower respiratory infection within 4 weeks prior to the Screening Visit.
  • Significant, non-reversible, active pulmonary disease (e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis, bronchiectasis, tuberculosis).
  • Known Human Immunodeficiency Virus (HIV)-positive status.
  • A smoking history equivalent to "10 pack years" (i.e., at least 1 pack of 20 cigarettes /day for 10 years or 10 packs/day for 1 year, etc)
  • Current smoking history within 12 months prior to the Screening Visit.
  • Current evidence or history of alcohol and/or substance abuse within 12 months prior to the Screening Visit.
  • Patients who have taken beta-blocking agents, tricyclic antidepressants, monoamine oxidase inhibitors, astemizole (Hismanal), quinidine type antiarrhythmics, or potent CYP 3A4 inhibitors such as ketoconazole within the past week.
  • Current use of medications that will have an effect on bronchospasm and/or pulmonary function.
  • Current evidence or history of hypersensitivity or idiosyncratic reaction to test medications or components.
  • Receipt of an investigational drug within 30 days of the Screening Visit (12 weeks if an oral or injectable steroid).
  • Current participation in a clinical study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00476073
Other Study ID Numbers  ICMJE FLT3501
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mundipharma Research Limited
Study Sponsor  ICMJE Mundipharma Research Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dr Blagden, MD
PRS Account Mundipharma Research Limited
Verification Date October 2018

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