Official Title: “Open Label, 12-Week Clinical Trial to Assess Efficacy, Safety, Treatment Adherence and Quality of Life Impact of Mometasone Furoate Dry Powder 400 Mcg Once-Daily in Persistent Mild-Moderate Asthmatic Patients at Least 12 Years Old”

Open label, 12-week clinical trial to assess efficacy, safety, treatment adherence and Quality of Life impact of Mometasone Furoate dry powder 400 mcg Once-daily in persistent mild-moderate asthmatic patients at least 12 years old.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Study Primary Completion Date: August 2008

Intervention(s) in this Clinical Trial

• Drug: Mometasone Furoate
  • MF 400 mcg once daily, in the evening through 12 weeks.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Arm 1
  • Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.

Primary Measures

• Assess mean change in FEV1 from baseline to the endpoint of the study.
  • Time Frame: Week 12, Visit 5
    Safety Issue?: No

Secondary Measures

• AM & PM PEFR
  • Time Frame: Week 12, Visit 5
    Safety Issue?: No
• Morning and evening Asthma symptoms based on a 3 point scale (4 individual symptoms) and 24 points (summed).
  • Time Frame: Week 12, Visit 5
    Safety Issue?: No
• Number of Nocturnal Awakenings and use of Rescue Medication in each episode.
  • Time Frame: Week 12, Visit 5
    Safety Issue?: No
• Mean change in Asthma Specific HRQoL Questionnaire and General HRQoL Questionnaire scores from baseline to endpoint
  • Time Frame: Week 12, Visit 5
    Safety Issue?: No
• Number of puffs of salbutamol used daily
  • Time Frame: Week 12, Visit 5
    Safety Issue?: No
• Investigator's assessment of Response to Therapy based on a 5-point scale
  • Time Frame: Week 12, Visit 5
    Safety Issue?: No
• Patient's assessment of Response to Therapy based on a 5-point scale
  • Time Frame: Week 12, Visit 5
    Safety Issue?: No
• Proportion of subjects with one or more mild, moderate or severe asthma exacerbations
  • Time Frame: Week 12, Visit 5
    Safety Issue?: No
• Mean percentage of Treatment Adherence from baseline to endpoint
  • Time Frame: Week 12, Visit 5
    Safety Issue?: No

Inclusion Criteria:

• Willingness to participate and comply with procedures by signing a written informed consent
• 12 years of age or older of either gender and any race
• Women of childbearing potential (includes women who are less than 1 year postmenopausal and currently are or will become sexually active during the study) must be using or agree to use an acceptable method of birth control unless they are surgically sterilized
• Must understand and be able to adhere to dosing and visit schedules, and agree to record symptom severity scores, PEFR values, medication times, and concomitant medications accurately and consistently in a daily diary.
• Diagnosed history of mild-moderate persistent asthma for at least 12 months.
• FEV1 must be >60% of predicted normal or personal best FEV1 during the last 12 months.
• Using daily inhaled corticosteroids for at least 30 days prior to Screening. In the Screening Visit patients FEV1 should be >= 65% to <= 90% predicted.
• Asthma Symptom Total daily (AM+PM) severity score at Screening Visit should be <= 2.
• For 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 - <= 1000mcg/day; BDP >= 200 - <= 1000 mcg/day; TA >= 400 - <= 2000 mcg/day
• During the ICS Dose Reduction period (max. of 4 weeks; min. of 1 week) of sequential
• ICS Dose Reduction (approximately 50% reduction in daily dose or discontinue according treatment scheme), subjects must demonstrate a measurable loss of asthma control, with both A) Decreased Lung Function (from the Screening value in absolute FEV1 of >= 10% or >= 220ml OR a decrease in AM PEFR of 25% from the average value for the pre-ICS
• Dose Reduction period on at least 2 consecutive days out of the last 7 days) AND B)
• Increased Symptoms (Total AM and PM symptom score of >= 10 out of 24 (using 0-3 scale for each of 4 individual symptoms) on at least 2 days out of the last 7 days OR
• Increased use of rescue medication from the average value for the pre-ICS Dose
• Reduction period (one week) of >= 2 puffs on at least 2 days out of the last 7 days)
• Once criterion above have been fulfilled, subjects can be initiated if the FEV1 is 60%-80% predicted
• Subjects must agree to inform their usual treating physicians of their participation in this study

Exclusion Criteria:

• Females who are pregnant or breast-feeding.
• Subjects who have not observed the designated washout periods for any of the prohibited medications
• 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 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.
• Subjects with clinical evidence of chronic obstructive pulmonary disease or lung diseases other than asthma.
• Subjects who have experienced an upper or lower respiratory tract infection within the previous 2 weeks prior to the Screening Visit.
• Subjects with evidence of clinically significant oropharyngeal candidiasis
• Subjects with any clinically significant immunologic, metabolic, cardiovascular, neurologic, hematologic, gastrointestinal, cerebrovascular, or respiratory disease (other than asthma), or any other disorder which may interfere with the study evaluations or affect subject safety.
• Subjects with a history of drug abuse, antagonistic personality, poor motivation, hypochondriasis, or any other emotional or intellectual problems that are likely to limit the validity of consent to participate in the study

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Schering-Plough

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00687531

Study ID Number: P04879

ClinicalTrials.gov Identifier: NCT00687531

Health Authority: Mexico: Federal Commission for Sanitary Risks Protection