Efficacy and Safety of Flutiform® pMDI in Adult Patients With Mild to Moderate-severe Reversible Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mundipharma Research Limited
ClinicalTrials.gov Identifier:
NCT00476073
First received: May 17, 2007
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label

Resource links provided by NLM:


Further study details as provided by Mundipharma Research Limited:

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

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

Estimated Enrollment: 200
Study Start Date: April 2007
Study Completion Date: January 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00476073

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

Additional Information:
No publications provided by Mundipharma Research Limited

Additional 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
Study First Received: May 17, 2007
Last Updated: August 12, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on October 29, 2014