Asthma MedDRA version: 8.1 Level: LLT Classification code 10003553 Term: Asthma
Conditions
Sponsors
Schering-Plough Research Institute, a division of Schering Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •A subject must have been using a medium daily dose of ICS (either 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 daily doses of ICS are defined in the protocol. •If, based upon the medical judgement of the Investigator, there is no inherent harm in changing a subject’s current asthma therapy, the subject (and parent/guardian, if appliable) must be willing to discontinue their prescribed ICS or ICS/LABA combination at the Screening Visit, and be transferred to open-label treatment with MF MDI 200 microgram BID for 2-3 weeks prior to the Baseline/Randomization Visit. • To document the diagnosis of asthma and assure the subject's responsiveness to bronchodilators before randomization, one of the following methods can be used at the Screening Visit, Day -14, or thereafter, but prior to the Baseline Visit: * The subject must demonstrate an increase in absolute FEV1 of at least 12% and at least 200 mL within 15 minutes after administration of four inhalations of albuterol/salbutamol (total dose of 360 to 400 micrograms) or of nebulised SABA (2.5 mg) if confirmed as standard office practice , OR. * The subject must demonstrate a PEF variability of more that 20% expressed as a percentage of the best and lowest morning pre-bronchodilator PEF over at least one week, OR * The subject must demonstrate a diurnal variation in PEF of more than 20% based on the difference between the pre-bronchodilator morning value and the post-bronchodilator value from the evening before, expressed as percentage of the mean daily PEF value. •At the Screening Visit, the subject's FEV1 must be >=60% and =60% and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •A subject who demonstrates a change (increase or decrease) in absolute FEV1 of > 20% at any time from the Screening Visit up to and including the Baseline Visit. •A subject who requires the use of >8 inhalations per day of SABA MDI or >=2 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 experiences a decrease in AM or PM PEF below the Screening Period stability limit on any 2 consecutive days prior to randomization. •A subject who experiences an occurence of any clinical deterioration of asthma that results in emergency treatment, hospitalization due to asthma, or treatment with additional, excluded asthma medication (other than SABA) as judged by the clinical investigator at any time from the Screening Visit up to and including the Baseline Visit. •A subject who is a smoker or ex-smoker and has smoked within the previous year or has had a cumulative smoking history of > 10 pack-years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To determine the efficacy of mometasone furoate/formoterol (MF/F) MDI 200/10 mcg BID compared with mometasone furoate (MF MDI 200 mcg BID), in order to assess the added benefit of formoterol (F MDI 10 mcg BID) to the combination. 2. To determine the efficiacy of MF/F MDI 200/10 mcg BID compared with F MDI 10 mcg BID, in order to assess the benefit of the steroid component of the combination.;Secondary Objective: To assess the efficacy of MF/F MDI 200/10 mcg BID compared with placebo as measured by the Asthma Quality of Life Questionnaire [AQLQ(S)] total score, the Asthma Control Questionnaire (ACQ) total score, and the proporation of nights with nocturnal awakenings due to asthma which require use of short-acting inhaled beta2-agonist (SABA) rescue medication.;Primary end point(s): 1. The AUC (0-12 hr) of the change from baseline to Week 12 in FEV1 for the comparison of MF/F vs MF. The average of the two pre-dose FEV1 measurements (30 minutes prior to dosing and 0 hour, immediately prior to dosing) at the Baseline Visit will be subtracted from each of the serial measurements over the 12-hour period. The AUC will be calculated based on these changes from baseline evaluations. 2. Time-to-first asthma exacerbation over the 26-week treatment period for the comparison of MF/F vs F. 'Asthma exacerbation' is defined in the protocol. | — |
Countries
Denmark, Estonia, Hungary
Outcome results
None listed