A Study of an Intravenous Drug in Pediatric Patients With Acute Asthma

This study has been completed.

Study NCT00117338 Information provided by Merck

First Received on June 30, 2005. Last Updated on April 7, 2010 History of Changes

Results First Received: March 16, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Asthma
Interventions:	Drug: montelukast sodium Drug: Comparator: placebo (unspecified)

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 World Wide (U.S., Europe, Asia, South America, and Lithuania) Multicenter Study. Study Start Date: August 2005 Primary Completion Date: March 2008 Study Completion Date: April 2008

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

Phase III World Wide (U.S., Europe, Asia, South America, and Lithuania) Multicenter Study.

Study Start Date: August 2005 Primary Completion Date: March 2008 Study Completion Date: April 2008

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Montelukast Intravenous (IV) 5.25 mg	No text entered.
Placebo	No text entered.

Participant Flow: Overall Study

	Montelukast Intravenous (IV) 5.25 mg	Placebo
STARTED	145	131
COMPLETED	140	127
NOT COMPLETED	5	4
Adverse Event	0	1
Protocol Violation	3	2
Withdrawal by Subject	1	0
Did not meet Inclusion Criteria	1	0
Lack of Efficacy	0	1

Baseline Characteristics

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Reporting Groups

	Description
Montelukast Intravenous (IV) 5.25 mg	No text entered.
Placebo	No text entered.

Baseline Measures

	Montelukast Intravenous (IV) 5.25 mg	Placebo	Total
Number of Participants [units: participants]	145	131	276
Age [units: years] Mean ± Standard Deviation	9.2 ± 2.36	8.9 ± 2.32	9.1 ± 2.34
Gender [units: participants]
Female	55	50	105
Male	90	81	171
Race/Ethnicity [units: participants]
White (Non-Hispanic)	16	16	32
Black	18	16	34
Hispanic	59	53	112
Asian	18	18	36
Multi-Racial	34	27	61
Other	0	1	1
Baseline FEV 1 (L) ^[1] [units: Liters] Mean ± Standard Deviation	1.1 ± 0.5	1.0 ± 0.5	1.0 ± 0.5
Baseline FEV1 (Percent predicted) ^[2] [units: Percent] Mean ± Standard Deviation	51.8 ± 16.8	50.6 ± 17.4	51.2 ± 17.1

[1]	Forced Expiratory Volume in one second, measured in Liters (FEV 1 (L)) A total of 4/276 (1—montelukast; 3—placebo) randomized patients were excluded from the Full Analysis Set (FAS) of the primary endpoint
[2]	Percent of predicted baseline Forced Expiratory Volume in one second (FEV1) A total of 4/276 (1—montelukast; 3—placebo) randomized patients were excluded from the Full Analysis Set (FAS) of the primary endpoint

[1]

Forced Expiratory Volume in one second, measured in Liters (FEV 1 (L))

A total of 4/276 (1—montelukast; 3—placebo) randomized patients were excluded from the Full Analysis Set (FAS) of the primary endpoint

[2]

Percent of predicted baseline Forced Expiratory Volume in one second (FEV1)

A total of 4/276 (1—montelukast; 3—placebo) randomized patients were excluded from the Full Analysis Set (FAS) of the primary endpoint

Outcome Measures

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1. Primary:

Improvement in FEV1 (Forced Expiratory Volume in 1 Second) Over the First 60 Minutes After Administration [ Time Frame: Baseline and (time weighted average over) 60 Minutes ]

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2. Secondary:

Change From Baseline in Modified Pulmonary Index [mPI] Score [ Time Frame: Baseline and 60 minutes ]

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3. Secondary:

Number of Participants With Treatment Failure (Hospitalization or Time to Decision to Discharge > 2 Hours) [ Time Frame: 120 minutes ]

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4. Secondary:

Time-Weighted Average Change in FEV1 Over 45 Minutes Following the End of Study Drug Administration [ Time Frame: Baseline and (time-weighed average over) 45 Minutes ]

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5. Secondary:

Time-Weighted Average Change in FEV1 Over 30 Minutes Following the End of Study Drug Administration [ Time Frame: Baseline and (time-weighted average over) 30 Minutes ]

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6. Secondary:

Change in FEV1 After 15 Minutes Following the End of Study Drug Administration [ Time Frame: Baseline and 15 Minutes ]

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7. Secondary:

Total Dose of β-agonist Administered Per Patient Over a Period of 2 Hours Following the End of Study Drug Administration [ Time Frame: 120 minutes ]

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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
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Results Point of Contact:

Name/Title: Senior Vice President, Clinical and Quantitative Sciences
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372

No publications provided by Merck

Publications automatically indexed to this study:

Morris CR, Becker AB, Piñieiro A, Massaad R, Green SA, Smugar SS, Gurner DM. A randomized, placebo-controlled study of intravenous montelukast in children with acute asthma. Ann Allergy Asthma Immunol. 2010 Feb;104(2):161-71.

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00117338 History of Changes
Other Study ID Numbers:	2005_026, MK0476-301
Study First Received:	June 30, 2005
Results First Received:	March 16, 2009
Last Updated:	April 7, 2010
Health Authority:	United States: Food and Drug Administration