Clinical Trial to Assess Efficacy, Safety, Treatment Adherence and Quality of Life Impact of Mometasone Furoate in Asthmatic Patients
- Conditions
- Persistent asthmaTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2014-004926-17-Outside-EU/EEA
- Lead Sponsor
- Schering-Plough S.A.de C.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 360
• 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to assess mean change in FEV1 from baseline to the endpoint of study.;Secondary Objective: 1. Changes from baseline in the subject's twice-daily assessment (AM & PM) symptoms<br>2. Changes from Baseline in AM and OM Peak Expiratory Flow Rate(PEFR)<br>3. Changes in Score of Asthma Quality of Life Questionnaire from baseline to the endpoint and general Quality of Life Questionnaires<br>;Primary end point(s): The primary endpoint for the trial was mean change from Baseline in the FEV1 (percentage change from baseline).;Timepoint(s) of evaluation of this end point: The FEV1 measurements were done in Visit 1, Visit 2 and Visit 5.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The secondary endpoints for the trial were: PEFR, asthma symptoms and the measure of Health Quality of Life.;Timepoint(s) of evaluation of this end point: The PEFR variable was measured throughout the whole study visits (day 1, week 4[visit 3], week 8 [visit 4] and week 12 [visit 5]).<br>The Asthma quality of life and general quality of life questionnaires were conducted in Baseline (visit 2) protocol visit and endpoint protocol visit (visit 5).<br>