Montelukast Back to School Asthma Study (0476-340)

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00461032
• Other study ID #: 0476-340
• Secondary ID: MK0476-3402007_5
• Status: Completed
• Phase: Phase 3
• Start date: June 2006
• Est. completion date: November 2006

Study information

• Verified date: January 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1162
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• montelukast
montelukast 5 mg tablet Once a day (QD) for 8 weeks
• Comparator: Placebo
Placebo to montelukast QD for 8 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Percentage of Days With Worsening Asthma (as Measured on Daily Diaries) in Pediatric Asthmatic Participants	A day of worsening asthma is a day with: increase from baseline in ß-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.	8 Week treatment period initiated at the beginning of a school year
Secondary	Number of Participants With the Occurrence of One or More Health Care Utilizations (as Measured on Daily Diaries)	Health care utilization is defined as unanticipated asthma care in an office or clinic, emergent or hospital setting.	8 Week treatment period initiated at the beginning of a school year
Secondary	Percentage of Days With Increased ß-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
Secondary	Percentage of Days With Increased Daytime Asthma Symptom Score by >50% From Baseline (as Measured on Daily Diaries) in Pediatric Asthmatic Participants	Daytime asthma symptom score was calculated as the sum of the responses (0 (best) to 5 (worst)) to three daytime symptom questions.	8 Week treatment period initiated at the beginning of a school year