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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 : February 9, 2016
Information provided by (Responsible Party):
Mundipharma Research Limited

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.

Condition or disease Intervention/treatment Phase
Asthma Bronchiale Drug: FLUTIFORM® (Formoterol fumarate / Fluticasone propionate) Phase 3

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 : Interventional  (Clinical Trial)
Actual Enrollment : 228 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Study Start Date : April 2007
Primary Completion Date : January 2008
Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Primary Outcome Measures :
  1. FEV1, (Forced expiratory volume in the 1st second).

Secondary Outcome Measures :
  1. Other lung function tests, AQLQ, Safety Assessments.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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): NCT00476073

United Kingdom
Dr Blagden
Chesterfield, United Kingdom
Sponsors and Collaborators
Mundipharma Research Limited
Principal Investigator: Dr Blagden, MD

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mundipharma Research Limited
ClinicalTrials.gov Identifier: NCT00476073     History of Changes
Other Study ID Numbers: FLT3501
First Posted: May 21, 2007    Key Record Dates
Last Update Posted: February 9, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
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