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: - 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 prior to initiating MF MDI run-in medication. - A subject must have a history of = 2 asthma-related unscheduled visits to either a physician or to an emergency room within the past year OR =3 asthma-related unscheduled visits within the past 2 years. NOTE: Documentation in the chart that a subject had a worsening in his/her asthma condition requiring a change in treatment without a visit to a physician or ER will also be accepted as an 'unscheduled visit'. - 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 approximately 15 to 20 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 mean 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 (before taking albuterol/salbutamol) morning value and the postbronchodilator value (after taking albuterol/salbutamol) from the evening before, expressed as a percentage of the mean daily PEF value on any day during the open-label Run in Period. NOTE: If a subject is to be qualified using diurnal variation, the subject should be instructed to perform his/her PEF evaluation after using his/her bronchodilator in the evening. - 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, including serum pregnancy for females of child-bearing potential, and urinalysis) conducted at the Screening Visit must be within normal limits or clinically acceptable to the investigator/sponsor before the subject is instructed to start using open-label MF MDI run-in medication. - 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. In Germany, a chest x-ray will not be performed at Screening. Only subjects who have a historical chest x-ray result within the last 12 months will be permitted into the study. - 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 birt
Exclusion criteria
Exclusion criteria: - A subject who experiences a decrease in AM or PM PEF below the Run-in 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 (including oral or other systemic corticosteroids but allowing SABA).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate non-inferiority between mometasone furoate/formoterol fumarate (MF/F) MDI 200/10 mcg BID and fluticasone propionate/salmeterol (F/SC) dry powder inhaler (DPI) 250/50 mcg BID on the effect of lung function after 12 weeks of treatment, in subjects with persistent asthma requiring maintenance treatment on medium doses of inhaled glucocorticosteroids.;Secondary Objective: To assess overall safety, onset-of-action, and asthma control, between two treatment groups: MF/F MDI 200/10 mcg BID and F/SC DPI (Diskus) 250/50 mcg BID.;Primary end point(s): The primary efficacy endpoint is the AUC(0-12 hr) of the change from Baseline to Week 12 in FEV1. 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. The primary endpoint analysis will be performed when all when all randomized subjects have completed Phase 1 of treatment, ie, following completion of the first 12 weeks of randomized treatment. In addition, the safety data will be used to accrue additional subjects as part of the overall safety assessment and total exposure for the MF/F FDC product. There is no plan to stop or interrupt the study (assuming that no significant subject health-related issues arise) as a result of these analyses; subjects will continue to be treated through the time that these analyses are performed and for the remainder of the 52-week Treatment Period. The results of this Phase 1 analysis, representing the final analysis of the primary endpoint, will be restricted to a small group of individuals responsible for health authority submission preparation and will not be disclosed to investigational or sponsor personnel without a need to know. | — |
Countries
Czech Republic, Estonia, Finland, Germany, Latvia, Lithuania, Netherlands
Outcome results
None listed