Montelukast in Pediatric Allergic Asthma (0476-336)(COMPLETED)

This study has been completed.

Sponsor:

Information provided by:

Merck Sharp & Dohme Corp.

ClinicalTrials.gov Identifier:

NCT00289874

First received: February 7, 2006

Last updated: September 10, 2010

Last verified: September 2010

History of Changes

Results First Received: September 9, 2009

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

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
One hundred three sites in US; Prime Therapy: March 2006 to July 2007

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients who had unresolved symptoms and signs of an upper respiratory tract infection between Visits 1 and 2, or had evidence of active, clinically significant sinus infection within 1 week of Visit 1 or between Visits 1 and 2, or failed to meet minimum requirement for daytime asthma symptoms and daily β-agonist use were excluded.

Reporting Groups

	Description
Montelukast 5 mg	Montelukast 5 mg chewable tablet orally once daily at bedtime for 3 weeks.
Placebo	Montelukast matching-image placebo tablet orally once daily at bedtime for 3 weeks.

Participant Flow: Overall Study

	Montelukast 5 mg	Placebo
STARTED	203	218
COMPLETED	197	210
NOT COMPLETED	6	8
Adverse Event	1	5
Lost to Follow-up	1	1
Protocol Violation	3	2
Did not meet eligibility	1	0

Baseline Characteristics

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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.
No text entered.

Reporting Groups

	Description
Montelukast 5 mg	Montelukast 5 mg chewable tablet orally once daily at bedtime for 3 weeks.
Placebo	Montelukast matching-image placebo tablet orally once daily at bedtime for 3 weeks.
Total	Total of all reporting groups

Baseline Measures

	Montelukast 5 mg	Placebo	Total
Number of Participants [units: participants]	203	218	421
Age [units: years] Mean ± Standard Deviation	10.6 ± 2.4	10.7 ± 2.4	10.6 ± 2.4
Gender [units: participants]
Female	81	90	171
Male	122	128	250
Daily β-agonist use [units: Puffs/Day] Mean ± Standard Deviation	3.01 ± 1.77	2.72 ± 1.68	2.86 ± 1.73
Forced expiratory volume in 1 second (FEV1) [units: Liters] Mean ± Standard Deviation	1.81 ± 0.57	1.84 ± 0.60	1.83 ± 0.58

Outcome Measures

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1. Primary:

Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 3 [ Time Frame: Baseline and week 3 ]

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2. Secondary:

Percent Change From Baseline in Mean Daily "as Needed" β-agonist Use Over the 3-week Treatment Period [ Time Frame: Baseline and Week 3 ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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
Safety is reported in the literature.

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.

Results Point of Contact:

Name/Title: Vice President of Late Stage Development
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@spcorp.com

Publications:

Papadopoulos NG, Philip G, Giezek H, Watkins M, Smugar SS, Polos PG. The efficacy of montelukast during the allergy season in pediatric patients with persistent asthma and seasonal aeroallergen sensitivity. J Asthma. 2009 May;46(4):413-20. doi: 10.1080/02770900902847727. Erratum in: J Asthma. 2009 Oct;46(8):858.

Responsible Party:	Vice President of Late Stage Development, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00289874 History of Changes
Other Study ID Numbers:	2006_001, MK0476-336
Study First Received:	February 7, 2006
Results First Received:	September 9, 2009
Last Updated:	September 10, 2010
Health Authority:	United States: Food and Drug Administration

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