Montelukast Back to School Asthma Study (0476-340)

• Sponsor: Organon and Co (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00461032
• Collaborator: (none)
• Enrollment: 1,162
• Arms: 2
• Duration (Months): 5

Study Details

Study Description

Brief Summary

This study, in children with chronic asthma, evaluates the number of days of worsening asthma during 8 weeks of treatment with montelukast after treatment is started for the first day of school.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: montelukast; Drug: Comparator: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 1162 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Randomized, Double-blind, Placebo-Controlled Parallel Group 8-week Study to Evaluate the Efficacy and Safety of Chewable Montelukast When Initiated at the Start of the School Year in Pediatric Patients With Chronic Asthma
• Study Start Date: Jun 1, 2006
• Actual Primary Completion Date: Nov 1, 2006
• Actual Study Completion Date: Nov 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 montelukast	Drug: montelukast; montelukast 5 mg tablet Once a day (QD) for 8 weeks
Placebo Comparator: 2 Placebo	Drug: Comparator: Placebo; Placebo to montelukast QD for 8 weeks

Outcome Measures

Primary Outcome Measures

1. Mean Percentage of Days With Worsening Asthma (as Measured on Daily Diaries) in Pediatric Asthmatic Participants [8 Week treatment period initiated at the beginning of a school year]

   A day of worsening asthma is a day with: increase from baseline in β-agonist use (> 70% and a min increase of 2 puffs); > 50% increase from baseline in daytime symptoms score; awake "all night"; increase from baseline in inhaled corticosteroid use ≥ 100% or oral corticosteroid rescue for worsening asthma; or unanticipated healthcare utilization.

Secondary Outcome Measures

1. Number of Participants With the Occurrence of One or More Health Care Utilizations (as Measured on Daily Diaries) [8 Week treatment period initiated at the beginning of a school year]

   Health care utilization is defined as unanticipated asthma care in an office or clinic, emergent or hospital setting.

2. Percentage of Days With Increased β-agonist Use by >70% and a Minimum Increase of 2 Puffs From Baseline (as Measured on Daily Diaries) in Pediatric Asthmatic Participants [8 Week treatment period initiated at the beginning of a school year]

3. Percentage of Days With Increased Daytime Asthma Symptom Score by >50% From Baseline (as Measured on Daily Diaries) in Pediatric Asthmatic Participants [8 Week treatment period initiated at the beginning of a school year]

   Daytime asthma symptom score was calculated as the sum of the responses (0 (best) to 5 (worst)) to three daytime symptom questions.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 14 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male and female non-smoking Participants, ages 6 to 14 years, with chronic asthma, history of at least one asthma exacerbation associated with a cold within the past year and a documented history of asthma that required treatment with any asthma medication within 6 months prior to Visit 1

Exclusion Criteria:

• Participant cannot have any other acute or chronic pulmonary disorder, or hospitalization for asthma more than three times within one year prior to signing informed consent

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Organon and Co

Investigators

• Study Director: Medical Monitor, Merck Sharp & Dohme LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

• Weiss KB, Gern JE, Johnston NW, Sears MR, Jones CA, Jia G, Watkins MW, Smugar SS, Edelman JM, Grant EN. The Back to School asthma study: the effect of montelukast on asthma burden when initiated prophylactically at the start of the school year. Ann Allergy Asthma Immunol. 2010 Aug;105(2):174-81. doi: 10.1016/j.anai.2010.04.018. Epub 2010 Jul 1.

• Responsible Party: Organon and Co
• ClinicalTrials.gov Identifier: NCT00461032
• Other Study ID Numbers: 0476-340; MK0476-340; 2007_539
• First Posted: Apr 17, 2007
• Last Update Posted: Feb 2, 2022
• Last Verified: Jan 1, 2022

• Additional relevant MeSH terms: Asthma; Montelukast

Study Results

Participant Flow

Recruitment Details	Participants were randomized at 165 sites in the US and Canada. Therapy period: June to November 2006 (including screening period).
Pre-assignment Detail	Participants who were hospitalized for asthma in the 4 weeks prior to randomization or who required excluded medications were excluded from randomization.

Arm/Group Title	Placebo	Montelukast 5 mg
Arm/Group Description	Montelukast matching-image placebo tablet taken orally once daily at bedtime for 8 weeks.	Montelukast 5 mg chewable tablet taken orally once daily (OD) at bedtime for 8 weeks.
Period Title: Overall Study
STARTED	582	580
COMPLETED	545	536
NOT COMPLETED	37	44

Baseline Characteristics

Arm/Group Title	Placebo	Montelukast 5 mg	Total
Arm/Group Description	Montelukast matching-image placebo tablet taken orally once daily at bedtime for 8 weeks.	Montelukast 5 mg chewable tablet taken orally once daily (OD) at bedtime for 8 weeks.	Total of all reporting groups
Overall Participants	582	580	1162
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	9.9 (2.5)	9.9 (2.4)	9.9 (2.5)
Sex: Female, Male (Count of Participants)
Female	236 40.5%	225 38.8%	461 39.7%
Male	346 59.5%	355 61.2%	701 60.3%
Daytime Asthma Symptom Score (Units on a Scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Units on a Scale]	1.32 (1.81)	1.35 (1.94)	1.34 (1.88)
β-Agonist Use (puffs/day) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [puffs/day]	0.62 (1.11)	0.54 (0.94)	0.58 (1.03)

Outcome Measures

1. Primary Outcome

Title	Mean Percentage of Days With Worsening Asthma (as Measured on Daily Diaries) in Pediatric Asthmatic Participants
Description	A day of worsening asthma is a day with: increase from baseline in β-agonist use (> 70% and a min increase of 2 puffs); > 50% increase from baseline in daytime symptoms score; awake "all night"; increase from baseline in inhaled corticosteroid use ≥ 100% or oral corticosteroid rescue for worsening asthma; or unanticipated healthcare utilization.
Time Frame	8 Week treatment period initiated at the beginning of a school year

Outcome Measure Data

Analysis Population Description

The primary efficacy analysis was based on full-analysis-set (FAS) population. This included all randomized participants who received at least one dose of double-blinded therapy and had a valid efficacy measurement. The percent of worsening asthma days was calculated from at least 7 days of diary data. Missing diary data were not imputed.

Arm/Group Title	Placebo	Montelukast 5 mg
Arm/Group Description	Montelukast matching-image placebo tablet taken orally once daily at bedtime for 8 weeks.	Montelukast 5 mg chewable tablet taken orally once daily (OD) at bedtime for 8 weeks.
Measure Participants	499	499
Least Squares Mean (95% Confidence Interval) [Percentage of Days]	27.23	24.26

2. Secondary Outcome

Title	Number of Participants With the Occurrence of One or More Health Care Utilizations (as Measured on Daily Diaries)
Description	Health care utilization is defined as unanticipated asthma care in an office or clinic, emergent or hospital setting.
Time Frame	8 Week treatment period initiated at the beginning of a school year

Outcome Measure Data

Analysis Population Description

The analysis was based on the FAS population. This included all randomized participants who received at least 1 dose of study medication and had a valid efficacy measurement. Occurrence of one or more health care utilization was derived from the available diary data and was set to missing if no diary data were available.

Arm/Group Title	Placebo	Montelukast 5 mg
Arm/Group Description	Montelukast matching-image placebo tablet taken orally once daily at bedtime for 8 weeks.	Montelukast 5 mg chewable tablet taken orally once daily (OD) at bedtime for 8 weeks.
Measure Participants	476	466
Participants requiring Health Care Utilization	70 12%	55 9.5%
Participants not requiring Health Care Utilization	406 69.8%	411 70.9%

3. Secondary Outcome

Title	Percentage of Days With Increased β-agonist Use by >70% and a Minimum Increase of 2 Puffs From Baseline (as Measured on Daily Diaries) in Pediatric Asthmatic Participants
Time Frame	8 Week treatment period initiated at the beginning of a school year

Outcome Measure Data

Analysis Population Description

The secondary efficacy analysis was based on full-analysis-set (FAS) population. This included all randomized participants who received at least one dose of double-blinded therapy and had valid efficacy measurement for at least 7 days of diary data.

Arm/Group Title	Placebo	Montelukast 5 mg
Arm/Group Description	Montelukast matching-image placebo tablet taken orally once daily at bedtime for 8 weeks.	Montelukast 5 mg chewable tablet taken orally once daily (OD) at bedtime for 8 weeks.
Measure Participants	491	495
Least Squares Mean (95% Confidence Interval) [Percentage of Days]	7.02	6.04

4. Secondary Outcome

Title	Percentage of Days With Increased Daytime Asthma Symptom Score by >50% From Baseline (as Measured on Daily Diaries) in Pediatric Asthmatic Participants
Description	Daytime asthma symptom score was calculated as the sum of the responses (0 (best) to 5 (worst)) to three daytime symptom questions.
Time Frame	8 Week treatment period initiated at the beginning of a school year

Outcome Measure Data

Analysis Population Description

The secondary efficacy analysis was based on full-analysis-set (FAS) population. This included all randomized participants who received at least one dose of double-blinded therapy and had a valid efficacy measurement. Variables that were measured as the average over the treatment period were defined from at least 7 days of evaluable diary data.

Arm/Group Title	Placebo	Montelukast 5 mg
Arm/Group Description	Montelukast matching-image placebo tablet taken orally once daily at bedtime for 8 weeks.	Montelukast 5 mg chewable tablet taken orally once daily (OD) at bedtime for 8 weeks.
Measure Participants	491	496
Least Squares Mean (95% Confidence Interval) [Percentage of Days]	17.4	16.03

Adverse Events

Time Frame	Adverse events (AEs) were collected during the 8 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 AE tables (566 placebo & 566 montelukast) is the number that received treatment. 16 placebo & 14 montelukast randomized participants did not receive 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	Placebo		Montelukast 5 mg
Arm/Group Description	Montelukast matching-image placebo tablet taken orally once daily at bedtime for 8 weeks.		Montelukast 5 mg chewable tablet taken orally once daily (OD) at bedtime for 8 weeks.
All Cause Mortality
	Placebo		Montelukast 5 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		Montelukast 5 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/566 (0.2%)		4/566 (0.7%)
Gastrointestinal disorders
Abdominal pain	0/566 (0%)		1/566 (0.2%)
Infections and infestations
Pneumonia	0/566 (0%)		1/566 (0.2%)
Respiratory, thoracic and mediastinal disorders
Asthma	1/566 (0.2%)		2/566 (0.4%)
Other (Not Including Serious) Adverse Events
	Placebo		Montelukast 5 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	189/566 (33.4%)		191/566 (33.7%)
Blood and lymphatic system disorders
Lymphadenopathy	0/566 (0%)		1/566 (0.2%)
Congenital, familial and genetic disorders
Lymphangioma	1/566 (0.2%)		0/566 (0%)
Ear and labyrinth disorders
Ear pain	1/566 (0.2%)		3/566 (0.5%)
Eye disorders
Conjunctivitis	1/566 (0.2%)		1/566 (0.2%)
Gastrointestinal disorders
Abdominal discomfort	0/566 (0%)		1/566 (0.2%)
Abdominal pain	1/566 (0.2%)		2/566 (0.4%)
Abdominal pain upper	3/566 (0.5%)		2/566 (0.4%)
Constipation	1/566 (0.2%)		1/566 (0.2%)
Diarrhoea	3/566 (0.5%)		2/566 (0.4%)
Gastrooesophageal reflux disease	0/566 (0%)		1/566 (0.2%)
Haematochezia	0/566 (0%)		1/566 (0.2%)
Nausea	0/566 (0%)		4/566 (0.7%)
Stomach discomfort	1/566 (0.2%)		3/566 (0.5%)
Toothache	1/566 (0.2%)		0/566 (0%)
Vomiting	3/566 (0.5%)		5/566 (0.9%)
General disorders
Chest discomfort	1/566 (0.2%)		0/566 (0%)
Chest pain	0/566 (0%)		2/566 (0.4%)
Fatigue	0/566 (0%)		1/566 (0.2%)
Malaise	1/566 (0.2%)		3/566 (0.5%)
Pyrexia	5/566 (0.9%)		9/566 (1.6%)
Immune system disorders
Allergy to arthropod bite	1/566 (0.2%)		0/566 (0%)
Hypersensitivity	0/566 (0%)		2/566 (0.4%)
Infections and infestations
Acarodermatitis	0/566 (0%)		1/566 (0.2%)
Acute sinusitis	4/566 (0.7%)		3/566 (0.5%)
Body tinea	1/566 (0.2%)		0/566 (0%)
Bronchiolitis	0/566 (0%)		1/566 (0.2%)
Bronchitis	6/566 (1.1%)		2/566 (0.4%)
Bronchitis acute	1/566 (0.2%)		0/566 (0%)
Candidiasis	0/566 (0%)		1/566 (0.2%)
Cellulitis	1/566 (0.2%)		1/566 (0.2%)
Ear infection	2/566 (0.4%)		0/566 (0%)
Eye infection	1/566 (0.2%)		0/566 (0%)
Folliculitis	1/566 (0.2%)		0/566 (0%)
Gastroenteritis viral	6/566 (1.1%)		8/566 (1.4%)
Herpes simplex	1/566 (0.2%)		0/566 (0%)
Hordeolum	1/566 (0.2%)		3/566 (0.5%)
Impetigo	0/566 (0%)		2/566 (0.4%)
Influenza	1/566 (0.2%)		0/566 (0%)
Labyrinthitis	0/566 (0%)		1/566 (0.2%)
Nasopharyngitis	24/566 (4.2%)		31/566 (5.5%)
Otitis externa	3/566 (0.5%)		0/566 (0%)
Otitis media	3/566 (0.5%)		7/566 (1.2%)
Otitis media acute	1/566 (0.2%)		0/566 (0%)
Pharyngitis	3/566 (0.5%)		2/566 (0.4%)
Pharyngitis streptococcal	7/566 (1.2%)		9/566 (1.6%)
Pharyngotonsillitis	1/566 (0.2%)		0/566 (0%)
Pneumonia	1/566 (0.2%)		1/566 (0.2%)
Pneumonia viral	1/566 (0.2%)		0/566 (0%)
Rhinitis	2/566 (0.4%)		3/566 (0.5%)
Sinusitis	11/566 (1.9%)		15/566 (2.7%)
Skin infection	1/566 (0.2%)		0/566 (0%)
Staphylococcal infection	0/566 (0%)		1/566 (0.2%)
Subcutaneous abscess	1/566 (0.2%)		0/566 (0%)
Tonsillitis	4/566 (0.7%)		1/566 (0.2%)
Upper respiratory tract infection	45/566 (8%)		31/566 (5.5%)
Urinary tract infection	1/566 (0.2%)		1/566 (0.2%)
Varicella	2/566 (0.4%)		1/566 (0.2%)
Viral infection	10/566 (1.8%)		5/566 (0.9%)
Viral upper respiratory tract infection	11/566 (1.9%)		7/566 (1.2%)
Injury, poisoning and procedural complications
Arthropod bite	1/566 (0.2%)		1/566 (0.2%)
Arthropod sting	0/566 (0%)		1/566 (0.2%)
Contusion	1/566 (0.2%)		1/566 (0.2%)
Foot fracture	2/566 (0.4%)		1/566 (0.2%)
Foreign body in eye	0/566 (0%)		1/566 (0.2%)
Hand fracture	2/566 (0.4%)		0/566 (0%)
Joint sprain	0/566 (0%)		2/566 (0.4%)
Neck injury	1/566 (0.2%)		0/566 (0%)
Soft tissue injury	0/566 (0%)		1/566 (0.2%)
Tibia fracture	0/566 (0%)		1/566 (0.2%)
Upper limb fracture	1/566 (0.2%)		0/566 (0%)
Investigations
Weight decreased	1/566 (0.2%)		0/566 (0%)
Metabolism and nutrition disorders
Anorexia	0/566 (0%)		1/566 (0.2%)
Musculoskeletal and connective tissue disorders
Exostosis	1/566 (0.2%)		0/566 (0%)
Joint effusion	1/566 (0.2%)		0/566 (0%)
Pain in extremity	0/566 (0%)		2/566 (0.4%)
Tendonitis	1/566 (0.2%)		0/566 (0%)
Nervous system disorders
Headache	7/566 (1.2%)		8/566 (1.4%)
Lethargy	1/566 (0.2%)		0/566 (0%)
Migraine	3/566 (0.5%)		1/566 (0.2%)
Sinus headache	1/566 (0.2%)		0/566 (0%)
Psychiatric disorders
Insomnia	0/566 (0%)		3/566 (0.5%)
Mood swings	0/566 (0%)		1/566 (0.2%)
Sleep terror	1/566 (0.2%)		0/566 (0%)
Renal and urinary disorders
Urinary incontinence	0/566 (0%)		1/566 (0.2%)
Reproductive system and breast disorders
Nipple pain	0/566 (0%)		1/566 (0.2%)
Nipple swelling	0/566 (0%)		1/566 (0.2%)
Respiratory, thoracic and mediastinal disorders
Asthma	28/566 (4.9%)		21/566 (3.7%)
Bronchial hyperreactivity	0/566 (0%)		1/566 (0.2%)
Bronchospasm	1/566 (0.2%)		0/566 (0%)
Cough	11/566 (1.9%)		8/566 (1.4%)
Epistaxis	2/566 (0.4%)		3/566 (0.5%)
Nasal congestion	2/566 (0.4%)		2/566 (0.4%)
Nocturnal dyspnoea	1/566 (0.2%)		0/566 (0%)
Pharyngolaryngeal pain	9/566 (1.6%)		13/566 (2.3%)
Rhinitis allergic	6/566 (1.1%)		4/566 (0.7%)
Rhinorrhoea	3/566 (0.5%)		1/566 (0.2%)
Sinus congestion	2/566 (0.4%)		1/566 (0.2%)
Sneezing	2/566 (0.4%)		0/566 (0%)
Upper respiratory tract congestion	1/566 (0.2%)		0/566 (0%)
Wheezing	1/566 (0.2%)		3/566 (0.5%)
Skin and subcutaneous tissue disorders
Dermatitis	1/566 (0.2%)		0/566 (0%)
Dermatitis contact	1/566 (0.2%)		1/566 (0.2%)
Erythema	0/566 (0%)		1/566 (0.2%)
Pruritus	1/566 (0.2%)		1/566 (0.2%)
Rash	2/566 (0.4%)		4/566 (0.7%)
Rash generalised	1/566 (0.2%)		0/566 (0%)
Seborrhoea	1/566 (0.2%)		0/566 (0%)
Skin irritation	0/566 (0%)		1/566 (0.2%)
Skin lesion	0/566 (0%)		1/566 (0.2%)
Urticaria	3/566 (0.5%)		4/566 (0.7%)
Surgical and medical procedures
Endodontic procedure	0/566 (0%)		1/566 (0.2%)
Wisdom teeth removal	1/566 (0.2%)		0/566 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.