Clinical Trial to Assess Efficacy, Safety, Treatment Adherence and Quality of Life Impact of Mome⦠(NCT00687531) | Clinical Trial Compass
TerminatedPhase 4
Clinical Trial to Assess Efficacy, Safety, Treatment Adherence and Quality of Life Impact of Mometasone Furoate in Asthmatic Patients (Study P04879)(TERMINATED)
385 participantsStarted 2006-11
Plain-language 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.
Who can participate
Age range12 Years
SexALL
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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. ofā¦