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

October 22, 2018 updated by: Mundipharma Research Limited
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

228

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
FEV1, (Forced expiratory volume in the 1st second).

Secondary Outcome Measures

Outcome Measure
Other lung function tests, AQLQ, Safety Assessments.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mundipharma Research Limited

Investigators

  • Principal Investigator: Dr Blagden, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

May 17, 2007

First Submitted That Met QC Criteria

May 18, 2007

First Posted (Estimate)

May 21, 2007

Study Record Updates

Last Update Posted (Actual)

October 24, 2018

Last Update Submitted That Met QC Criteria

October 22, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FLT3501

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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