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

• ClinicalTrials.gov Identifier: NCT00289874
• Recruitment Status: Completed
• First Posted: February 10, 2006
• Results First Posted: October 1, 2010
• Last Update Posted: February 17, 2016
• Sponsor: Merck Sharp & Dohme Corp.
• Information provided by (Responsible Party): Merck Sharp & Dohme Corp.

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Asthma
• Interventions: Drug: montelukast sodium; Drug: Comparator: Placebo
• Enrollment: 421

Participant Flow

Recruitment Details	One hundred three sites in US; Prime Therapy: March 2006 to July 2007
Pre-assignment Details	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.

Arm/Group Title	Montelukast 5 mg	Placebo
Arm/Group Description	Montelukast 5 mg chewable tablet orally once daily at bedtime for 3 weeks.	Montelukast matching-image placebo tablet orally once daily at bedtime for 3 weeks.
Period Title: Overall Study
Started	203	218
Completed	197	210
Not Completed	6	8
Reason Not Completed
Adverse Event	1	5
Lost to Follow-up	1	1
Protocol Violation	3	2
Did not meet eligibility	1	0

Baseline Characteristics

Arm/Group Title		Montelukast 5 mg	Placebo	Total
Arm/Group Description		Montelukast 5 mg chewable tablet orally once daily at bedtime for 3 weeks.	Montelukast matching-image placebo tablet orally once daily at bedtime for 3 weeks.	Total of all reporting groups
Overall Number of Baseline Participants		203	218	421
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	203 participants	218 participants	421 participants
		10.6 (2.4)	10.7 (2.4)	10.6 (2.4)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	203 participants	218 participants	421 participants
	Female	81 39.9%	90 41.3%	171 40.6%
	Male	122 60.1%	128 58.7%	250 59.4%
Daily β-agonist use; Mean (Standard Deviation); Unit of measure: Puffs/Day
	Number Analyzed	203 participants	218 participants	421 participants
		3.01 (1.77)	2.72 (1.68)	2.86 (1.73)
Forced expiratory volume in 1 second (FEV1); Mean (Standard Deviation); Unit of measure: Liters
	Number Analyzed	203 participants	218 participants	421 participants
		1.81 (0.57)	1.84 (0.60)	1.83 (0.58)

Outcome Measures

1. Primary Outcome

Title	Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 3
Description	Percent change from baseline in FEV1, a measure of airway function, at Week 3
Time Frame	Baseline and week 3

Outcome Measure Data

Analysis Population Description

The full analysis set population (i.e., includes all patients who had baseline and on-treatment measurements).

Arm/Group Title	Montelukast 5 mg	Placebo
Arm/Group Description:	Montelukast 5 mg chewable tablet orally once daily at bedtime for 3 weeks.	Montelukast matching-image placebo tablet orally once daily at bedtime for 3 weeks.
Overall Number of Participants Analyzed	199	208
Least Squares Mean (95% Confidence Interval); Unit of Measure: Percent Change
	9.53; (7.05 to 12.01)	9.15; (6.71 to 11.59)

2. Secondary Outcome

Title	Percent Change From Baseline in Mean Daily "as Needed" β-agonist Use Over the 3-week Treatment Period
Description	Percent change from baseline in average daily β-agonist use over the 3-week treatment period
Time Frame	Baseline and Week 3

Outcome Measure Data

Analysis Population Description

The full analysis set population (i.e., includes all patients who had baseline and on-treatment measurements).

Arm/Group Title	Montelukast 5 mg	Placebo
Arm/Group Description:	Montelukast 5 mg chewable tablet orally once daily at bedtime for 3 weeks.	Montelukast matching-image placebo tablet orally once daily at bedtime for 3 weeks.
Overall Number of Participants Analyzed	198	212
Median (Standard Deviation); Unit of Measure: Percent Change
	-18.88 (84.75)	-12.40 (53.88)

Adverse Events

Time Frame	Adverse events (AEs) were collected during the 6 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
Adverse Event Reporting Description	The number of participants listed in the SAE table (203 montelukast & 217 placebo) is the number that received treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
Arm/Group Title	Montelukast 5 mg	Placebo
Arm/Group Description	Montelukast 5 mg chewable tablet orally once daily at bedtime for 3 weeks.	Montelukast matching-image placebo tablet orally once daily at bedtime for 3 weeks.
All-Cause Mortality
	Montelukast 5 mg	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	Montelukast 5 mg	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/203 (0.00%)	4/217 (1.84%)
Injury, poisoning and procedural complications
Femur fracture * 1	0/203 (0.00%)	1/217 (0.46%)
Overdose * 1	0/203 (0.00%)	1/217 (0.46%)
Respiratory, thoracic and mediastinal disorders
Asthma * 1	0/203 (0.00%)	2/217 (0.92%)
Respiratory distress * 1	0/203 (0.00%)	1/217 (0.46%)
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA (Unspecified)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Montelukast 5 mg	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/203 (0.00%)	0/217 (0.00%)

Limitations and Caveats

Safety is reported in the literature.

More Information

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.

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: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp
• Phone: 1-800-672-6372
• EMail: ClinicalTrialsDisclosure@merck.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: Merck Sharp & Dohme Corp.
• ClinicalTrials.gov Identifier: NCT00289874
• Other Study ID Numbers: 0476-336; 2006_001
• First Submitted: February 7, 2006
• First Posted: February 10, 2006
• Results First Submitted: September 9, 2009
• Results First Posted: October 1, 2010
• Last Update Posted: February 17, 2016