Study of MK0476 in Adult Patients With Acute Asthma

This study has been completed.

Study NCT00442338 Information provided by Merck

First Received on February 27, 2007. Last Updated on April 20, 2010 History of Changes

Results First Received: May 22, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Asthma
Interventions:	Drug: montelukast Drug: Comparator: Aminophylline

Participant Flow

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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 [ Time Frame: 60 minutes after drug administration ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

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 Sharp & Dohme Corp
phone: 1-800-672-6372

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00442338 History of Changes
Other Study ID Numbers:	2007_007, MK0476-334
Study First Received:	February 27, 2007
Results First Received:	May 22, 2009
Last Updated:	April 20, 2010
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency