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This will be an open-label, randomized, parallel-group comparison of mometasone furoate dry powder inhaler (MF-DPI) 400 mcg once daily administered in the morning vs. the evening for 12 weeks in subjects with asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Morning | Experimental |
| |
| Evening | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mometasone furoate | Device | MF-DPI 400 mcg once daily in the morning for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Between-treatment group comparisons (MF-DPI 400 mcg once daily in the morning compared to the evening) of daytime and nocturnal symptoms based on a 4 point scale. | 12 weeks | |
| To compare the incidence of adverse events of MF-DPI 400 mcg once daily administered in the morning compared to the evening. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To assess morning vs. evening compliance with therapy. | 12 weeks | |
| To assess subject satisfaction with the Twisthaler^TM device. | 12 weeks |
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Inclusion Criteria:
Subjects (and their parent/guardian if the subject is <18) must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
Subjects must be >=12 years of age (unless restricted to an older age by local ethical committees or national health authorities), of either gender and any race.
Subjects must have had a history of asthma for >=6 months.
If the subject is taking inhaled corticosteroids, the daily dose must be <= the upper limit defined below:
Women of childbearing potential must have a negative urine (hCG) pregnancy test on the day of randomization (Baseline visit).
Women of childbearing potential (includes women who are <1 year postmenopausal) must be using an acceptable method of birth control (eg, hormonal contraceptive, medically prescribed IUD, condom in combination with spermicide) or be surgically sterilized (eg, hysterectomy or tubal ligation).
Subjects must agree to inform their usual treating physician (if other than the study investigator) of their participation in this study.
Exclusion Criteria:
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Mometasone furoate | Device | MF-DPI 400 mcg once daily in the evening for 12 weeks |
|
|
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |