A Phase 3 interventional study of montelukast sodium and Comparator: Placebo in Asthma, sponsored by Organon and Co. Completed. Open to participants aged 6 Years to 14 Years. Per ClinicalTrials.gov, last updated 2022-02-02.
Sponsored by Organon and Co · Phase 3, Interventional, and Treatment
This is a 3-week study to evaluate FEV1 following treatment with drugs in persistent asthma which is also active during allergy seasons in pediatric patients with seasonal aeroallergen sensitivity.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 421 is above the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →Organon and Co is the lead sponsor of 478 studies on the registry; none are open to participants now.
Of its 21 completed or terminated interventional studies of FDA-regulated products, 17 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
montelukast
Drug: montelukast sodium
placebo
Drug: Comparator: Placebo
montelukast 5 mg chewable tablet once daily. Up to 3 weeks of treatment.
Also known as: MK0476
Placebo. Up to 3 weeks of treatment
Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 3
Percent change from baseline in FEV1, a measure of airway function, at Week 3
Time frame: Baseline and week 3
Percent Change From Baseline in Mean Daily "as Needed" β-agonist Use Over the 3-week Treatment Period
Percent change from baseline in average daily β-agonist use over the 3-week treatment period
Time frame: Baseline and Week 3
One hundred three sites in US; Prime Therapy: March 2006 to July 2007
| Milestone | Montelukast 5 mg | Placebo |
|---|---|---|
| Started | 203 | 218 |
| Completed | 197 | 210 |
| Not completed | 6 | 8 |
| Withdrew: Adverse event | 1 | 5 |
| Withdrew: Lost to follow-up | 1 | 1 |
| Withdrew: Protocol violation | 3 | 2 |
| Withdrew: Did not meet eligibility | 1 | 0 |
Percent change from baseline in FEV1, a measure of airway function, at Week 3
| Percent Change | Montelukast 5 mg | Placebo |
|---|---|---|
| Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 3 | 9.53 (7.05 to 12.01) | 9.15 (6.71 to 11.59) |
Percent change from baseline in average daily β-agonist use over the 3-week treatment period
| Percent Change | Montelukast 5 mg | Placebo |
|---|---|---|
| Percent Change From Baseline in Mean Daily "as Needed" β-agonist Use Over the 3-week Treatment Period | -18.88 ± 84.75 | -12.40 ± 53.88 |
Collected over 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. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Montelukast 5 mg | — | 0/203 (0%) | 0/203 (0%) |
| Placebo | — | 4/217 (1.8%) | 0/217 (0%) |
| Event | Montelukast 5 mg | Placebo |
|---|---|---|
| AsthmaRespiratory, thoracic and mediastinal disorders | 0/203 | 2/217 |
| Femur fractureInjury, poisoning and procedural complications | 0/203 | 1/217 |
| OverdoseInjury, poisoning and procedural complications | 0/203 | 1/217 |
| Respiratory distressRespiratory, thoracic and mediastinal disorders | 0/203 | 1/217 |
| Age, Continuous(years) | Montelukast 5 mg | Placebo | Total |
|---|---|---|---|
| Mean | 10.6 ± 2.4 | 10.7 ± 2.4 | 10.6 ± 2.4 |
| Sex: Female, Male(Participants) | Montelukast 5 mg | Placebo | Total |
|---|---|---|---|
| Female | 81 | 90 | 171 |
| Male | 122 | 128 | 250 |
| Daily β-agonist use(Puffs/Day) | Montelukast 5 mg | Placebo | Total |
|---|---|---|---|
| Mean | 3.01 ± 1.77 | 2.72 ± 1.68 | 2.86 ± 1.73 |
| Forced expiratory volume in 1 second (FEV1)(Liters) | Montelukast 5 mg | Placebo | Total |
|---|---|---|---|
| Mean | 1.81 ± 0.57 | 1.84 ± 0.60 | 1.83 ± 0.58 |
No study locations are listed for this record.
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Organon and Co