OPEN LABEL, 12-WEEK CLINICAL TRIAL TO ASSESS EFFICACY, SAFETY, TREATMENT ADHERENCE AND QUALITY OF LIFE IMPACT ON MOMETASONE FUROATE DRY POWDER 400 MCG ONCE DAILY IN PERSISTENT MILD-MODERATE ASTHMATIC PATIENTS AT LEAST 12 YEARS OLD (APEGO STUDY) - Clinical Trial to Assess Efficacy,Safety,Treatment Adherence&QOL Impact of MF in Asthmatic Patients

Schering-Plough S.A.de C.V.0 个研究点目标入组 360 人开始时间: 2015年4月16日最近更新: 2015年7月10日

适应症

试验速览

暂无简介。

•Subjects must have a diagnosed history of mild moderate persistent asthma for the last 12 months
•The Subject's FEV1 must be >=60% of predicted normal or personal best FEV1 during the last 12 months
•Subjects must have been using daily inhaled corticosteroids for at least 30 days prior to screening. In the screening visit patients FEV1 should be >/= 65% to • Asthma symptom total daily (AM +PM) severity score at the screening should be • For the two weeks prior to screening, subjects must have been on a stable regimen of one of the following twice daily regimen: FP >=100 -<= 500 mcg/day, BUD >= 200 - <= 1000 mcg/day, BDP >= 200 - <= 1000 mcg/day, TA >= 400 - < =2000 mcg/day
•During the ICS Dose Reduction period of sequential ICS dose reduction, subjects must demonstrate a measurable loss of asthma control, with both A) Decreased Lung Function (either FEV1 or PEFR) and B) Increased Symptoms.
•Are the trial subjects under 18? no
•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 216
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 62

•Female subjects who are pregnant or breast-feeding.
•Subjects who have not observed the designated washout periods for any of the prohibited medications outlined
•Subjects who have used any investigational product within 30 days or any antibodies for asthma or allergic rhinitis in the past 90 days prior to enrollment.
•Subjects who have any clinically significant deviation from normal in the physical examination that, in the Investigator’s judgment, may interfere with the study evaluations or affect subject safety.
•Subjects who have required systemic steroids within the previous month.
•Subjects who are allergic or have an idiosyncratic reaction to corticosteroids.
•Subjects who have required inpatient hospitalization for asthma control within the previous 3 months, or more than once in the previous 6 months.

发起方

Schering-Plough S.A.de C.V.