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NCT00140881 Clinical Trial

A Study to Determine the Effect of Montelukast Sodium as an Episode Modifier in the Treatment of Infrequent Episodic Asthma in Children (0476-165)

Asthma Clinical Trial

Official title:
A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Determine the Effect of Montelukast Sodium as an Episode Modifier in the Treatment of Infrequent Episodic Asthma in Children

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00140881
Other study ID # 0476-165
Secondary ID 2005_055
Status Completed
Phase Phase 4
First received
Last updated
Start date June 1, 2000
Est. completion date February 14, 2003

Study information
Verified date February 2022
Source Organon and Co
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A 53-week study to determine the effect of montelukast sodium when given to children (with infrequent episodic asthma) at the earliest symptoms of an acute episode of asthma.

Recruitment information / eligibility
Status Completed
Enrollment 220
Est. completion date February 14, 2003
Est. primary completion date February 14, 2003
Accepts healthy volunteers No
Gender All
Age group 2 Years to 14 Years
Eligibility Inclusion Criteria: - Males or females between the ages of 2 and 14 who have infrequent episodic asthma.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• MK0476; montelukast sodium

• Comparator: placebo

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Organon and Co

References & Publications (1)

Robertson CF, Price D, Henry R, Mellis C, Glasgow N, Fitzgerald D, Lee AJ, Turner J, Sant M. Short-course montelukast for intermittent asthma in children: a randomized controlled trial. Am J Respir Crit Care Med. 2007 Feb 15;175(4):323-9. Epub 2006 Nov 16. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Composite unscheduled acute health care resource utilisation (specific for asthma; unscheduled visits, GP attendance, ED attendance and hospital admission).
Secondary Parent/caregiver QOL endpoints.
Secondary The safety and tolerability of montelukast when use as an episode modifier.
Secondary The duration and severity of the episode assessed by the parent/caregiver symptom score and the use of b-agonist and oral corticosteroid.
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