Open-Label Safety Study of MF/F in Asthma

• Conditions: Persistent Asthma; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2014-004583-38-Outside-EU/EEA
• Lead Sponsor: Schering-Plough Research Institute, a division of Schering Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-06
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

A subject must be at least 12 years of age or older and of either sex.
Each subject must be willing and able to provide written informed consent for the trial. The legal representative (eg, parent or guardian) for a subject under the age of legal consent, or who otherwise is unable to provide independent consent, may provide written informed consent for the subject. Each subject of the age of assent must be willing and able to provide assent, in addition to consent from the legal representative, to participate in the trial.
A subject must have a diagnosis of asthma of at least 6 months duration that is consistent with the following definitions: the diagnosis of asthma is based upon clinical history and examination, pulmonary function parameters, and response to beta-2 agonists, according to international guidelines (GINA 2010).
A subject must have been using a medium or high daily dose of ICS (either alone or in combination with
LABA) for at least 6 weeks and must have been on a stable asthma regimen (daily dose unchanged) for at least 2 weeks prior to Screening.
Medium daily doses of ICS are defined as follows (GINA 2010):
>500 to 1000 mcg beclomethasone dipropionate
>400 to 800 mcg budesonide DPI
>160 to 320 mcg ciclesonide
>1000 to 2000 mcg flunisolide
>250 to 500 mcg fluticasone propionate
>400 to <800 mcg mometasone furoate
>1000 to 2000 mcg triamcinolone acetonide
High daily doses of ICS are defined as follows (GINA 2010) :
>1000 to 2000 mcg beclomethasone dipropionate
>800 to 1600 mcg budesonide DPI
>320 to 1280 mcg ciclesonide
>2000 mcg flunisolide
>500 to 1000 mcg fluticasone propionate
=800 mometasone furoate
>2000 mcg triamcinolone acetonide
Both subject (and/or parent/guardian, if appropriate) and investigator must agree that changing therapy is acceptable and poses no inherent risk in the current study setting.
At the Screening Visit, or thereafter but prior to the Baseline Visit, the subject must demonstrate an
increase in absolute FEV1 of =12% and =200 mL within 15-20 minutes after administration of four
inhalations of albuterol/salbutamol (total dose of 360 to 400 mcg) or of nebulized SABA (2.5 mg), if confirmed as standard office practice. This requirement may be waived if there is documentation of post-SABA reversibility within 12 months prior to screening.
At Screening and at Baseline, each subject must have a pre-bronchodilator FEV1 =60% predicted.
Clinical laboratory tests (complete blood count, blood chemistries, urinalysis, and negative urine
pregnancy test for females of child-bearing potential) conducted at the Screening Visit must be within
normal limits or clinically acceptable to the investigator. If the laboratory value is not indicative of the
subject’s clinical status, one repeat test may be performed. If repeat value does not meet the criterion, subject may not continue the screening process.

Refer to protocol for complete list.

Are the trial subjects under 18? yes
Number of subjects for this age range: 4
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 44
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion Criteria

A subject who demonstrates a decrease in absolute FEV1 of >20% at any time from the Screening Visit up to and including the Baseline Visit.
A subject who experiences a clinical asthma exacerbation (defined as a deterioration of asthma that results in emergency treatment, hospitalization due to asthma, or treatment with additional, excluded asthma medication (other than SABAs) at any time from the Screening Visit up to and including the Baseline Visit.
A subject who has been treated in the emergency room (for a severe asthma exacerbation), or admitted to the hospital for management of airway obstruction within the last 3 months.
A subject who has ever required ventilator support for respiratory failure secondary to asthma.
A subject who has experienced an upper or lower respiratory tract infection (viral or bacterial) within the
previous 2 weeks prior to Screening and Baseline Visits. Visits can be rescheduled 2 weeks after complete resolution of the event to re-assess eligibility.
A subject who requires the use of >8 inhalations per day of SABA MDI or 2 or more nebulized treatments per day of 2.5 mg SABA on any 2 consecutive days from the Screening Visit up to and including the Baseline Visit.
A subject who is unable to perform acceptable and reproducible spirometry maneuvers at on-site visits or using the home PEF meter.
A subject who has smoked within the previous year or an ex-smoker with a cumulative smoking history >10 pack-years.
A subject who is known to be allergic to or intolerant. Refer to protocol for complete list.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified