Study of MK0476 in Adult Patients With Acute Asthma - Study Results

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Parallel Assignment
Condition:	Asthma
Interventions:	Drug: montelukast Drug: Comparator: Aminophylline

Participant Flow

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

Baseline Characteristics

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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]	Mild (Peak Expiratory Flow: 70%-80%), Moderate (Peak Expiratory Flow: 50%-70%), Severe (Peak Expiratory Flow: <=50%) or Serious (Peak Expiratory Flow: incapable measurement, cyanosis, head trip, disturbed consciousness, incontinence or asphyxia)

Outcome Measures

1. Primary:

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

Hide Outcome Measure 1

Measure Type	Primary
Measure Title	Improvement in Forced Expiratory Volume in One Second (FEV1) Within the First 60 Minutes After Administration
Measure Description	The Average of Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at 60 minutes after drug administration
Time Frame	60 minutes after drug administration
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Last observed value during the 60 minutes treatment period was used in the Per Protocol Set (PPS). Three patients in Montelukast 7 mg were excluded due to the missing data (1 patient) and the protocol deviations (2 patients), and two patients in Aminophylline 250 mg were excluded due to the missing data from the PPS analysis

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.

Measured Values

	Montelukast 7 mg	Montelukast 14 mg	Aminophylline 250 mg
Number of Participants Analyzed [units: participants]	27	30	29
Improvement in Forced Expiratory Volume in One Second (FEV1) Within the First 60 Minutes After Administration [units: Liter] Least Squares Mean ( 95% Confidence Interval )	0.07 ( 0.02 to 0.12 )	0.05 ( 0.00 to 0.11 )	0.06 ( 0.01 to 0.12 )

Statistical Analysis 1 for Improvement in Forced Expiratory Volume in One Second (FEV1) Within the First 60 Minutes After Administration

Groups ^[1]	Montelukast 7 mg vs. Aminophylline 250 mg
Method ^[2]	ANCOVA
P Value ^[3]	0.871
Mean Difference (Final Values) ^[4]	0.01
95% Confidence Interval	( -0.07 to 0.08 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	The model included a factor for treatment and using the baseline Forced Expiratory Volume in One Second (FEV1) as a covariate.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Improvement in Forced Expiratory Volume in One Second (FEV1) Within the First 60 Minutes After Administration

Groups ^[1]	Montelukast 14 mg vs. Aminophylline 250 mg
Method ^[2]	ANCOVA
P Value ^[3]	0.794
Mean Difference (Final Values) ^[4]	-0.01
95% Confidence Interval	( -0.08 to 0.06 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	The model included a factor for treatment and using the baseline Forced Expiratory Volume in One Second (FEV1) as a covariate.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck & Co., Inc.
phone: 1-800-672-6372

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2007_007, MK0476-334
Study First Received:	February 27, 2007
Results First Received:	May 22, 2009
Last Updated:	November 6, 2009
ClinicalTrials.gov Identifier:	NCT00442338 History of Changes
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency