Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
MF/F MDI 400/10 Mcg BID	Mometasone Furoate 400 mcg and formoterol 10 mcg fixed dose combination taken twice daily
MF/F MDI 200/10 Mcg BID	Mometasone Furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily
MF MDI 400 Mcg BID	Mometasone Furoate 400 mcg taken twice daily
Open-Label MF MDI 400 Mcg BID	Participants received 2 to 3 weeks (approximately) of open-label, run-in medication with MF MDI 400 mcg BID prior to the 12-week double-blind treatment period.

Participant Flow:   Overall Study

	MF/F MDI 400/10 Mcg BID	MF/F MDI 200/10 Mcg BID	MF MDI 400 Mcg BID	Open-Label MF MDI 400 Mcg BID
STARTED	255	233	240	106 [1]
COMPLETED	228	208	207	0
NOT COMPLETED	27	25	33	106
Adverse Event	2	2	5	9
Lack of Efficacy	8	11	13	1
Lost to Follow-up	0	1	1	3
Noncompliance with protocol	9	3	3	0
Did not meet protocol eligibility	5	7	5	76
Withdrawal by Subject	2	1	5	17
Administrative	1	0	1	0

Reporting Groups

	Description
MF/F MDI 400/10 Mcg BID	Mometasone Furoate 400 mcg and formoterol 10 mcg fixed dose combination taken twice daily
MF/F MDI 200/10 Mcg BID	Mometasone Furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily
MF MDI 400 Mcg BID	Mometasone Furoate 400 mcg taken twice daily

Baseline Measures

	MF/F MDI 400/10 Mcg BID	MF/F MDI 200/10 Mcg BID	MF MDI 400 Mcg BID	Total
Number of Participants   [units: participants]	255	233	240	728
Age   [units: participants]
<=18 years	23	18	22	63
Between 18 and 65 years	200	189	189	578
>=65 years	32	26	29	87
Gender   [units: participants]
Female	138	135	136	409
Male	117	98	104	319

1.  Primary:

Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 12 in Forced Expiratory Volume (Liters) in 1 Second (FEV1)   [ Time Frame: Baseline to Week 12 ]

2.  Secondary:

Change From Baseline to Week 12 in Asthma Control Questionnaire (ACQ) Total Score   [ Time Frame: Baseline to Week 12 ]

3.  Secondary:

Change From Baseline to Week 12 in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ[S]) Total Score   [ Time Frame: Baseline to Week 12 ]

4.  Secondary:

Change From Baseline in Proportion of Nights Across the Treatment Period With Nocturnal Awakenings Due to Asthma That Require Use of Short-Acting Beta Agonists (SABA)   [ Time Frame: 12-week Treatment Period ]