montelukast sodium
DrugMontelukast 4 mg (or 5 mg, depending on age of patient) qd + episode driven supplemental Pbo qd for 12 days for a 52-wk treatment period.
Other names: MK0476, Singulair®
NCT Number: NCT00337675
This is a year-long study evaluating the efficacy of both daily and intermittent treatment of asthma in children who experience symptoms episodically (i.e., seasonally, usually in the context of upper respiratory tract infection).
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Notify Me6 month–5 year
All sexes
Interventional
Phase 3
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Montelukast 4 mg (or 5 mg, depending on age of patient) qd + episode driven supplemental Pbo qd for 12 days for a 52-wk treatment period.
Other names: MK0476, Singulair®
Placebo (Pbo) qd + episode driven supplemental Pbo for 12 days for a 52-wk treatment period.
Time frame: 1-year treatment period
The rate per year of asthma episodes culminating in an asthma attack for each of the 3 treatment groups. Asthma attacks were defined as respiratory symptoms requiring healthcare resource utilization (HRU), which comprised unscheduled visits to a physician or emergency department, treatment with corticosteroids (oral, rectal, or inhaled), or hospitalization. Each day during an episode, the patient's legal guardian recorded all the HRU that was required specifically for breathing problems.
Time frame: 1 Year
Each day during an asthma episode, the patient's legal guardian was asked to rate each of the symptoms of wheeze and difficulty breathing on a 6-point scale (Scale 0 (best) to 5 (worst)). The average of the individual symptom scores on each of the 3 days prior to an asthma attack was reported. If a patient had multiple episodes during 1 year, the symptom scores were averaged across all the episodes.
Time frame: 1 Year
Each day during an asthma episode, the patient's legal guardian was asked to rate each of the symptoms of Wheeze, Difficulty Breathing, Interference with Activity, and Daytime Cough on a 6-point scale (Scale 0 (best) to 5 (worst)). The average of the individual symptom scores on each of the 12 days of intermittent treatment for an episode (before the first attack) was reported. If a patient had multiple episodes over 1 year, the symptom scores were averaged across all the episodes.
Organon and Co
Industry
A Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Study Evaluating the Effects of 2 Different Regimens of Montelukast (Daily Dosing and Intermittent, Episode-Driven Dosing) Compared With Placebo in the Treatment of Episodic Asthma in Children Aged 6 Months to 5 Years
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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