Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited from 25 centers worldwide. Patient screening began 05-May-2008 and the first patient was randomized on 29-May-2008. The last patient's last visit was completed on 16-Feb-2009.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
278 participants were screened; 144 were excluded. Randomized patients met the following criteria: FEV1 (Forced expiratory volume in one second) 50-80% predicted while withholding short-acting beta agonist (SABA) and reversibility of airway obstruction >12% following SABA documented on at least two of the following visits: Visits 1, 2, and 3.

Reporting Groups

	Description
Montelukast + Mometasone Then Placebo + Mometasone	Patients were randomized to receive montelukast 1 mg (milligram) and open-label mometasone 220 mcg (micrograms) once daily by inhalation in the first intervention; and placebo for montelukast and open-label mometasone 220 mcg once daily by inhalation in the second intervention (after washout). During washout, patients received open-label inhaled mometasone 220 mcg and single-blind placebo for montelukast once daily by inhalation.
Placebo + Mometasone Then Montelukast + Mometasone	Patients were randomized to receive placebo for montelukast and open-label mometasone 220 mcg once daily by inhalation in the first intervention; and montelukast 1 mg and open-label mometasone 220 mcg once daily by inhalation in the second intervention (after washout). During washout, patients received open-label inhaled mometasone 220 mcg and single-blind placebo for montelukast once daily by inhalation.

Participant Flow for 3 periods

Period 1:   First Intervention

	Montelukast + Mometasone Then Placebo + Mometasone	Placebo + Mometasone Then Montelukast + Mometasone
STARTED	66	68
COMPLETED	62	67
NOT COMPLETED	4	1
Lost to Follow-up	1	0
Protocol Violation	1	0
Withdrawal by Subject	1	0
Randomized did not start treatment	1	1

Period 2:   Washout Period of 1 Week

	Montelukast + Mometasone Then Placebo + Mometasone	Placebo + Mometasone Then Montelukast + Mometasone
STARTED	62	67
COMPLETED	62	65
NOT COMPLETED	0	2
Lost to Follow-up	0	1
Protocol Violation	0	1

Period 3:   Second Intervention

	Montelukast + Mometasone Then Placebo + Mometasone	Placebo + Mometasone Then Montelukast + Mometasone
STARTED	62	65
COMPLETED	61	64
NOT COMPLETED	1	1
Adverse Event	1	0
Death	0	1

Reporting Groups

	Description
Montelukast + Mometasone Then Placebo + Mometasone	Patients were randomized to receive montelukast 1 mg (milligram) and open-label mometasone 220 mcg (micrograms) once daily by inhalation in the first intervention; and placebo for montelukast and open-label mometasone 220 mcg once daily by inhalation in the second intervention (after washout). During washout, patients received open-label inhaled mometasone 220 mcg and single-blind placebo for montelukast once daily by inhalation.
Placebo + Mometasone Then Montelukast + Mometasone	Patients were randomized to receive placebo for montelukast and open-label mometasone 220 mcg once daily by inhalation in the first intervention; and montelukast 1 mg and open-label mometasone 220 mcg once daily by inhalation in the second intervention (after washout). During washout, patients received open-label inhaled mometasone 220 mcg and single-blind placebo for montelukast once daily by inhalation.

Baseline Measures

	Montelukast + Mometasone Then Placebo + Mometasone	Placebo + Mometasone Then Montelukast + Mometasone	Total
Number of Participants   [units: participants]	66	68	134
Age   [units: years] Mean ± Standard Deviation	39.2  ± 15.5	42.6  ± 14.8	40.9  ± 15.2
Gender   [units: participants]
Female	37	32	69
Male	29	36	65
Daytime Asthma Symptom Score (0 [best] to 6 [worst] Point Scale)   [units: Units on a Scale] Mean ± Standard Deviation	2.04  ± 0.90	2.18  ± 0.81	2.11  ± 0.85
FEV1 (Forced Expiratory Volume in One Second)   [units: L (Liter)] Mean ± Standard Deviation	2.14  ± 0.67	2.18  ± 0.55	2.16  ± 0.61
Nighttime Asthma Symptom Score (0 [best] to 3 [worst] Point Scale)   [units: Units on a Scale] Mean ± Standard Deviation	0.51  ± 0.53	0.46  ± 0.48	0.49  ± 0.50
Total Daily Beta-Agonist Use   [units: Puffs] Mean ± Standard Deviation	3.52  ± 2.49	3.55  ± 2.19	3.53  ± 2.34
Total Peripheral Blood Eosinophils   [units: 10^3/microliters] Mean ± Standard Deviation	0.46  ± 0.39	0.38  ± 0.31	0.42  ± 0.35

1.  Primary:

Change From Baseline in FEV1 (Forced Expiratory Volume; Volume of Air That is Exhaled During the First Second of a Forced Exhalation)   [ Time Frame: Baseline and 2 weeks ]

2.  Secondary:

Change From Baseline in Daytime Asthma Symptom Score   [ Time Frame: Baseline and 2 weeks ]

3.  Secondary:

Change From Baseline in Nighttime Asthma Symptom Score   [ Time Frame: Baseline and 2 weeks ]

4.  Other Pre-specified:

Change From Baseline in Total Daily β-agonist Use   [ Time Frame: Baseline and 2 weeks ]

5.  Other Pre-specified:

Percentage of Days With Asthma Control   [ Time Frame: 2 weeks ]

6.  Other Pre-specified:

Percentage of Days With Asthma Exacerbations   [ Time Frame: 2 Weeks ]

7.  Other Pre-specified:

Change From Baseline in Total Peripheral Blood Eosinophils   [ Time Frame: Baseline and 2 weeks ]

8.  Post-Hoc:

Change From Baseline in FEV1 (Forced Expiratory Volume; Volume of Air That is Exhaled During the First Second of a Forced Exhalation) in Patients Who Met Lung Function Eligibility Criteria Specifically at the Randomization Visit.   [ Time Frame: Baseline and 2 Weeks ]