A 52-Week Efficacy and Safety Non-Inferiority Study of Fluticasone Propionate/Salmeterol 250/50 mcg BID Delivered by Dry Powder Inhaler (DISKUS®) Versus Mometasone Furoate/Formoterol Fumarate 200/10 mcg BID Delivered by Pressurized Metered-Dose Inhaler in Persistent Asthmatics Previously Treated with Medium Doses of Inhaled Glucocorticosteroids.

Phase 1

Conditions: Asthma
MedDRA version: 8.1Level: LLTClassification code 10003553Term: Asthma

Registration Number: EUCTR2006-004169-33-SK

Lead Sponsor: Schering-Plough Research Institute, a division of Schering Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 664

Inclusion Criteria

• A subject must have been using a medium daily dose of ICS (alone or in
combination with a LABA) for at least 12 weeks and must have been on a stable
regimen (daily dose unchanged) for at least 2 weeks prior to Screening.
Medium total daily doses of ICS are defined in the protocol.
• If, based upon the medical judgment of the investigator, there is no inherent harm in changing the subject’s current asthma therapy, the subject (and subject’s legal representative, if applicable) must be willing to discontinue his/her prescribed ICS or ICS/LABA combination at the Screening Visit, and be transferred to open-label treatment with MF MDI 200 mcg BID for 2 to 4 weeks (run-in) prior to the Baseline/Randomization Visit.
• A subject must have a history of =2 asthma-related unscheduled visits to a physician or to an emergency room within the past year AND =3 asthma-related unscheduled visits within the past 2 years.
• To document the diagnosis of asthma and assure the subject's responsiveness to bronchodilators before randomization, one of the following methods can used at the Screening Visit, or at anytime prior to the Baseline Visit:
1. The subject must demonstrate an increase in absolute FEV1 of at least 12% and a volume increase of at least 200 mL within 15 minutes after administration of 4 inhalations of albuterol/salbutamol (total dose of 360 to 400 mcg) or of nebulized SABA (2.5 mg), if confirmed as standard office practice, OR
2. The subject must demonstrate a peak expiratory flow (PEF) variability of more than 20% expressed as a percentage of the highest and lowest morning pre-bronchodilator PEF over at least 1 week, OR
3. The subject must demonstrate a diurnal variation PEF of more than 20% based on the difference between the pre-bronchodilator morning value and the postbronchodilator value from the evening before, expressed as a percentage of the mean daily PEF value on any day during the open-label Run in Period.
• At the Screening and Baseline Visits, the subject’s FEV1 must be =60% and =90% of predicted when all restricted medications have been withheld for the appropriate intervals.
• Prior to randomization subjects must have used a total of 12 or more inhalations of SABA rescue medication during the last 10 days of run-in.
• Clinical laboratory tests (complete blood counts [CBC], blood chemistries, and urinalysis) conducted at the Screening Visit must be within normal limits or clinically acceptable to the investigator/sponsor.
• An electrocardiogram (ECG) performed at the Screening Visit, using a centralized trans-telephonic technology, must be clinically acceptable to the investigator.
• A chest x-ray performed at the Screening Visit, or within 12 months prior to the Screening Visit, must be clinically acceptable to the investigator.
• A non-pregnant female subject of childbearing potential must be using a medically acceptable, adequate form of birth control, as defined in the protocol.
• A female subject of childbearing potential who is not currently sexually active must agree and consent to using medically acceptable birth control, should she become sexually active during the course of this study.
• A female subject of childbearing potential must have a negative serum pregnancy test at Screening in order to be considered eligible for enrollment.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Eld

Exclusion Criteria

• A subject who demonstrates a change (increase or decrease) in absolute FEV1 of >20% at any time between the Screening and Baseline Visits. Note: PFTs will be performed in the morning.
• A subject who requires the use of greater than 8 inhalations per day of SABA (short-acting beta-agonists) MDI, or 2 or more nebulized treatments per day of 2.5 mg SABA, on any 2 consecutive days between the Screening and Baseline Visits.
• A subject who experiences a decrease in AM or PM PEF below the Screening Period stability limit on any 2 consecutive days prior to randomization. The average AM and average PM PEF respective values from the preceding 7 days are added, divided by the number of non-missing values, and multiplied by 0.70 to determine the stability limit.
• A subject who experiences a clinical asthma exacerbation: defined as a clinical deterioration of asthma, as judged by the clinical investigator between the Screening and Baseline Visits, that results in emergency treatment, hospitalization due to asthma, or treatment with additional, excluded asthma medication (other
than SABA).
• A subject with a clinically significant condition or situation, other than the condition being studied which, in the opinion of the investigator, may interfere with the study evaluations or optimal participation in the study.
• A subject who is a smoker or ex-smoker and has smoked within the previous year or has a cumulative smoking history >10 pack-years or equivalent.