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.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|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|
Questionnaires consisted of items such as General Health Condition (excellent/very good/good/regular/bad), Difficulty to Breathe (always/almost always/considerable part of time/partially/few amount of time/almost never/never), General Asthma Limitations (completely/a lot/enough to be considered/regular/a few/almost nothing/nothing), etc...
The questionnaires together consisted of 44 questions, each question with categorical variables as response. A Friedman test was performed to determine the significance of change in samples from baseline to endpoint, for each question.
|Study Start Date:||November 2006|
|Study Completion Date:||September 2009|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
Experimental: Mometasone Furoate
Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
Drug: Mometasone Furoate
Mometasone Furoate 400 mcg once daily, in the evening through 12 weeks.
Other Name: SCH 32088