Montelukast in Mild Asthmatic Children With Allergic Rhinitis (0476-367)(COMPLETED) - Study Results

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Asthma Allergic Rhinitis
Interventions:	Drug: montelukast sodium Drug: Comparator: inhaled corticosteroid

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Conducted at 5 sites in Korea, Feb2005~ Dec2007 in pediatric participants with comorbid mild asthma and allergic rhinitis. Participant's caregiver understands the study procedures and agrees to participate, signing the informed consent form.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Up to 1 week for wash-out - prior to baseline randomization.

Reporting Groups

	Description
Montelukast	Participants were treated for 12 months after randomization: Participants 2 to 5 years of age took one 4 mg chewable tablet and 6 to 14 years of age took one 5 mg chewable tablet daily in the evening. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
Inhaled Corticosteroids (ICS)	Participants were treated for 12 months after randomization: Each participant's physician selected the ICS agent, dose, and regimen. If participants had exacerbated from mild to moderate within 12 weeks, ICS was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.

Description

Montelukast

Participants were treated for 12 months after randomization: Participants 2 to 5 years of age took one 4 mg chewable tablet and 6 to 14 years of age took one 5 mg chewable tablet daily in the evening. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.

Inhaled Corticosteroids (ICS)

Participants were treated for 12 months after randomization: Each participant's physician selected the ICS agent, dose, and regimen. If participants had exacerbated from mild to moderate within 12 weeks, ICS was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.

Participant Flow: Overall Study

	Montelukast	Inhaled Corticosteroids (ICS)
STARTED	100	91
12 Weeks After Randomization	68 ^[1]	60 ^[1]
COMPLETED	66 ^[1]	56 ^[1]
NOT COMPLETED	34	35
Lost to Follow-up	32	34
Protocol Violation	1	1
Withdrawal by Subject	1	0

[1]	12 weeks after randomization was pre-specified as the time point for analysis

Baseline Characteristics

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Reporting Groups

	Description
Montelukast	Participants were treated for 12 months after randomization: Participants 2 to 5 years of age took one 4 mg chewable tablet and 6 to 14 years of age took one 5 mg chewable tablet daily in the evening. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
Inhaled Corticosteroids (ICS)	Participants were treated for 12 months after randomization: Each participant's physician selected the ICS agent, dose, and regimen. If participants had exacerbated from mild to moderate within 12 weeks, ICS was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.

Description

Montelukast

Participants were treated for 12 months after randomization: Participants 2 to 5 years of age took one 4 mg chewable tablet and 6 to 14 years of age took one 5 mg chewable tablet daily in the evening. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.

Inhaled Corticosteroids (ICS)

Participants were treated for 12 months after randomization: Each participant's physician selected the ICS agent, dose, and regimen. If participants had exacerbated from mild to moderate within 12 weeks, ICS was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.

Baseline Measures

	Montelukast	Inhaled Corticosteroids (ICS)	Total
Number of Participants [units: participants]	100	91	191
Age ^[1] [units: years] Mean ± Standard Deviation	5.4 ± 3.0	6.1 ± 2.6	5.8 ± 2.8
Gender ^[1] [units: participants]
Female	5	9	14
Male	19	20	39
Allergic rhinitis ^[2] [units: participants]
Mild-intermittent	14	17	31
Mild-persistent	10	12	22
Type of allergic rhinitis ^[1] [units: Participants]
Seasonal	13	15	28
Perennial	11	14	25
Daily allergic rhinitis symptom score ^[1] [units: Units on scale] Mean ± Standard Deviation	0.45 ± 0.35	0.31 ± 0.34	0.37 ± 0.35
Daytime asthma symptom score ^[1] [units: Units on scale] Mean ± Standard Deviation	0.32 ± 0.42	0.29 ± 0.40	0.30 ± 0.40
Duration of allergic rhinitis ^[1] [units: Years] Mean ± Standard Deviation	.4 ± .6	.8 ± 1	.6 ± .9
Duration of asthma ^[1] [units: Years] Mean ± Standard Deviation	.6 ± .7	1.1 ± 1.2	.9 ± 1.1

[1]	The primary efficacy parameter was a mean change from baseline to treatment for daytime asthma symptom score. Therefore 138 participants who didn't have a daytime asthma symptom score from the participant diary were not included.
[2]	Based on GINA guidelines. The primary efficacy parameter was a mean change from baseline to treatment for daytime asthma symptom score. Therefore 138 participants who didn't have a daytime asthma symptom score from the participant diary were not included.

Outcome Measures

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1. Primary:

Change From Baseline for Daytime Asthma Symptom Score [ Time Frame: at 12 weeks ]

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2. Secondary:

Change From Baseline for Daily Allergic Rhinitis Symptom Score [ Time Frame: 12 weeks ]

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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
This was an open-label study. Only 53 patients had diary information with daytime asthma symptom score - thus, 138 cases were dropped from analysis due to lack of daytime asthma symptom score.

Results Point of Contact:

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

No publications provided

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT00442559 History of Changes
Other Study ID Numbers:	MK-0476-367, 2007_003
Study First Received:	February 28, 2007
Results First Received:	October 12, 2008
Last Updated:	November 16, 2011
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)