Study of MK0476 in Adult Patients With Acute Asthma

This study has been completed.

Study NCT00442338 Information provided by Merck

First Received: February 27, 2007 Last Updated: November 6, 2009 History of Changes

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

Participant Flow

Hide 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

Hide Baseline Characteristics

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 ]

Show Outcome Measure 1

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Hide Other Adverse Events

Time Frame	No text entered.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	5%

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.

Other Adverse Events

	Montelukast 7 mg	Montelukast 14 mg	Aminophylline 250 mg
Total, other (not including serious) adverse events
# participants affected	5	1	3
Gastrointestinal disorders
Diarrhea * # participants affected / at risk	2/30 (6.67%)	0/30 (0.00%)	0/31 (0.00%)
General disorders
Oedema * # participants affected / at risk	2/30 (6.67%)	0/30 (0.00%)	0/31 (0.00%)
Investigations
Glucose urine present * # participants affected / at risk	2/30 (6.67%)	1/30 (3.33%)	1/31 (3.23%)
White blood cell count increased * # participants affected / at risk	0/30 (0.00%)	0/30 (0.00%)	2/31 (6.45%)

*	Indicates events were collected by non-systematic assessment.

More Information

Hide More Information

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