Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Phase III. Studied period: March 12, 2007 (date study drug was first administered to first patient) to August 1, 2007 (date study drug was last administered to last patient). Study was conducted at 31 clinical sites.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients with acute exacerbation of bronchial asthma received standard treatments of inhaled β-agonist or oxygen inhalation to treat the acute exacerbations during the 60 minutes in the screening period before the study randomization.

Reporting Groups

	Description
Montelukast 7 mg	Montelukast 7 mg Intravenous Administration
Montelukast 14 mg	Montelukast 14 mg Intravenous Administration
Aminophylline 250 mg	No text entered.

Participant Flow:   Overall Study

	Montelukast 7 mg	Montelukast 14 mg	Aminophylline 250 mg
STARTED	30	30	31
COMPLETED	30	30	31
NOT COMPLETED	0	0	0

Reporting Groups

	Description
Montelukast 7 mg	Montelukast 7 mg Intravenous Administration
Montelukast 14 mg	Montelukast 14 mg Intravenous Administration
Aminophylline 250 mg	No text entered.

Baseline Measures

	Montelukast 7 mg	Montelukast 14 mg	Aminophylline 250 mg	Total
Number of Participants   [units: participants]	30	30	31	91
Age   [units: years] Mean ± Standard Deviation	56.0 ± 12.3	56.7 ± 15.2	55.4 ± 14.5	56.0 ± 13.9
Gender   [units: participants]
Female	22	24	16	62
Male	8	6	15	29
Asthma Attack Severity based on Asthma Prevention and Management Guideline 2003, Japan[1] [units: participants]
Mild	21	18	26	65
Moderate	9	12	5	26
Severe	0	0	0	0
Serious	0	0	0	0
Baseline Forced Expiratory Volume in One Second (FEV1)   [units: Liter] Mean ± Standard Deviation	1.4 ± 0.3	1.2 ± 0.3	1.4 ± 0.5	1.3 ± 0.4
Duration of Asthma   [units: Years] Mean ± Standard Deviation	14.9 ± 10.4	13.9 ± 11.5	16.7 ± 14.1	15.2 ± 12.0

1.  Primary:

Improvement in Forced Expiratory Volume in One Second (FEV1) Within the First 60 Minutes After Administration   [ 60 minutes after drug administration ]