Montelukast Asthmatic Smoker Study (0476-332)(COMPLETED)

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00284856

First received: January 31, 2006

Last updated: April 6, 2011

Last verified: April 2011

History of Changes

Results First Received: April 6, 2011

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 Drug: Comparator: fluticasone

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 1640 participants enrolled in the study, 621 participants were excluded during screening and not randomized. The remaining 1019 participants were randomized.

Reporting Groups

	Description
Montelukast	Montelukast 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
Fluticasone	Fluticasone propionate 250 mcg twice daily and Montelukast matching placebo 10 mg tablet once daily at bedtime for 6 months
Placebo	Montelukast matching placebo 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months

Participant Flow: Overall Study

	Montelukast	Fluticasone	Placebo
STARTED	347	336	336
COMPLETED	296	286	276
NOT COMPLETED	51	50	60
Adverse Event	3	3	3
Lack of Efficacy	2	1	8
Lost to Follow-up	25	21	22
Protocol Violation	5	4	5
Withdrawal by Subject	12	16	18
Unspecified	4	5	4

Baseline Characteristics

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Reporting Groups

	Description
Montelukast	Montelukast 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
Fluticasone	Fluticasone propionate 250 mcg twice daily and Montelukast matching placebo 10 mg tablet once daily at bedtime for 6 months
Placebo	Montelukast matching placebo 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
Total	Total of all reporting groups

Baseline Measures

	Montelukast	Fluticasone	Placebo	Total
Number of Participants [units: participants]	347	336	336	1019
Age [units: years] Mean ± Standard Deviation	37.7 ± 10.4	38.4 ± 10.7	37.9 ± 9.9	38.0 ± 10.3
Gender [units: participants]
Female	163	147	166	476
Male	184	189	170	543

Outcome Measures

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1. Primary:

Percentage of Asthma-control Days Over the 6-month Treatment Period [ Time Frame: 6 months ]

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2. Secondary:

Change From Baseline in Mean Daytime Symptom Score Over a 6-month Treatment Period [ Time Frame: Baseline and 6 months ]

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3. Secondary:

Change From Baseline in Average Morning (AM) PEFR (Peak Expiratory Flow Rate) Over a 6-month Treatment Period [ Time Frame: Baseline and 6 months ]

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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: The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission. SPONSOR review can be expedited to meet publication guidelines.

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: 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:	Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00284856 History of Changes
Other Study ID Numbers:	MK-0476-332, 2005_108
Study First Received:	January 31, 2006
Results First Received:	April 6, 2011
Last Updated:	April 6, 2011
Health Authority:	Peru: General Directorate of Pharmaceuticals, Devices, and Drugs

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