Clinical trial NCT00687531: Clinical Trial to Assess Efficacy, Safety, Treatment Adherence and Quality of Life Impact of Mometasone Furoate in Asthmatic Patients (Study P04879)(TERMINATED)
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Asthma
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-05-30
Enrollment: 385
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Protocol deviations may have occurred that resulted in quality issues associated with reporting of the data.


Eligibility criteria: 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: fluticasone propionate (FP) \>= 100 - \<= 500 mcg/day; budesonide (BUD) \>= 200 - \<= 1000mcg/day; beclomethasone dipropionate (BDP) \>= 200 - \<= 1000 mcg/day; triamcinolone acetonide (TA) \>= 400 - \<= 2000 mcg/day
* During the inhaled corticosteroid (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

Primary outcomes:
measure: Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: Day 1 and Week 12
Secondary outcomes:
measure: Morning (AM) and Evening (PM) Peak Expiratory Flow Rate (PEFR)
timeFrame: Day 1 and Week 12
measure: Number of Items in the Asthma Quality of Life (QOL) Questionnaire and the General QOL Questionnaire That Had a Significant (Positive) Change From Baseline to Endpoint
timeFrame: Day 1 and Week 12
measure: Morning and Evening Asthma Symptoms Based on a 3 Point Scale (4 Individual Symptoms) and 24 Points (Summed).
timeFrame: Day 1 and Week 12
measure: Number of Nocturnal Awakenings
timeFrame: Day 1 and Week 12
measure: Number of Puffs of Salbutamol Used Daily
timeFrame: Day 1 and Week 12
measure: Investigator's Assessment of Response to Therapy Based on a 5-point Scale
timeFrame: Baseline, Week 12
measure: Patient's Assessment of Response to Therapy Based on a 5-point Scale
timeFrame: Baseline, Week 12
measure: Number of Participants With One or More Mild, Moderate or Severe Asthma Exacerbations
timeFrame: Day 1 and Week 12
measure: Number of Participants Who Adhered to Treatment
timeFrame: Day 1 to Week 12
measure: Number of Participants With Use of Rescue Medication in Each Episode
timeFrame: Day 1 and Week 12
Other outcomes:
Locations:
Study officials:
References: