Intermittent and Daily Dosing for Episodic (Periodic) Asthma

This study has been completed.

Study NCT00337675 Information provided by Merck

First Received on June 14, 2006. Last Updated on April 20, 2010 History of Changes

Results First Received: February 19, 2010

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 (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
Patients were recruited from 111 centers worldwide. Patient screening began 16-Oct-2006 and the first patient was randomized on 3-Nov-2006. The last patient's last visit was completed on 12-Aug-2009.

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

Patients were recruited from 111 centers worldwide.

Patient screening began 16-Oct-2006 and the first patient was randomized on 3-Nov-2006.

The last patient's last visit was completed on 12-Aug-2009.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
1979 screened; 208 excluded. Randomized patients met the following criteria: age 6-71 months, a history of episodic asthma symptoms that ranged between 2 and 6 episodes, depending on age, that were separated in time by periods without asthma symptoms. Patients had at least 1 corticosteroid treatment or were hospitalized for asthma at least 1 time.

Reporting Groups

	Description
Daily Montelukast	Patients were randomized to receive montelukast 4 mg (tablets or oral granules, depending on patient age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
Intermittent Montelukast	Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of montelukast 4 mg (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
Placebo	Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.

Participant Flow: Overall Study

	Daily Montelukast	Intermittent Montelukast	Placebo
STARTED	589	591	591
COMPLETED	492	488	492
NOT COMPLETED	97	103	99
Adverse Event	10	9	19
Lack of Efficacy	10	7	9
Lost to Follow-up	22	19	17
Physician Decision	9	17	14
Protocol Violation	21	24	19
Withdrawal by Subject	25	25	19
Progressive Disease	0	2	0
Trial Terminated	0	0	2

Baseline Characteristics

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Reporting Groups

	Description
Daily Montelukast	Patients were randomized to receive montelukast 4 mg (tablets or oral granules, depending on patient age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
Intermittent Montelukast	Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of montelukast 4 mg (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
Placebo	Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.

Baseline Measures

	Daily Montelukast	Intermittent Montelukast	Placebo	Total
Number of Participants [units: participants]	589	591	591	1771
Age [units: Months] Mean ( Full Range )	39.0 ( 6.0 to 71.0 )	39.5 ( 6.0 to 71.0 )	39.3 ( 7.0 to 71.0 )	39.2 ( 6.0 to 71.0 )
Gender [units: participants]
Female	239	226	238	703
Male	350	365	353	1068

Outcome Measures

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1. Primary:

Number of Asthma Episodes Culminating in Asthma Attack Over the 1-year Treatment Period [ Time Frame: 1-year treatment period ]

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2. Secondary:

Daily Average of Wheeze and Difficulty Breathing in the 3 Days Prior to Start of an Asthma Attack Within an Asthma Episode [ Time Frame: 1 Year ]

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3. Secondary:

Daily Average of the Mean Symptom Scores (Wheeze, Difficulty Breathing, Interference With Activity, and Daytime Cough) Assessed Over the 12-day Treatment Period of Asthma Episodes [ Time Frame: 1 Year ]

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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:	NCT00337675 History of Changes
Other Study ID Numbers:	2006_015, MK0476-302
Study First Received:	June 14, 2006
Results First Received:	February 19, 2010
Last Updated:	April 20, 2010
Health Authority:	United States: Food and Drug Administration