A Phase III Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Prospectively Evaluate Efficacy of Montelukast in Patients Aged 6 Months to 5 Years With Chronic Asthma

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-003428-38-DK

Enrollment

1050

Registered

2007-09-07

Start date

2007-10-11

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

asthma MedDRA version: 9.1 Level: LLT Classification code 10003553 Term: Asthma

Interventions

Trade Name: SINGULAIR 4 mg Oral Granules Product Name: SINGULAIR Pharmaceutical Form: Powder for oral solution INN or Proposed INN: Montelukast Sodium Concentration unit: mg milligram(s) Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Children aged 6 to 64 months with chronic asthma • Physician-diagnosed asthma (3 occurrences within past 6 months of asthma symptoms) • Up to 50% allowed use of concomitant ICS • Short-acting beta-agonist required on a pre-specified number of days during Period I • Asthma symptom score of at least 1 on a pre-specified number of days during Period I Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Active, acute, or chronic pulmonary disorder, other than asthma • Past intubation for asthma • Clinically significant, active co-morbid disease • Significant or unexplained abnormalities on physical exam • Use of short-acting beta-agonist other than albuterol/salbutamol

Design outcomes

Primary

Measure	Time frame
Main Objective: E.2.1 Main objective: To demonstrate that montelukast, compared with placebo, improves asthma control (as measured by the percentage of days without asthma ) over a 24-week treatment period in patients aged 6 months to 5 years with chronic asthma. To compare the safety profile of montelukast with placebo over the 24-week treatment period in patients aged 6 months to 5 years with chronic asthma.;Secondary Objective: E.2.2 Secondary objectives: To demonstrate that montelukast, compared with placebo, improves asthma control in patients aged 6 months to 5 years with chronic asthma over a 24-week treatment period as measured by: percentage of days without daytime symptoms; percentage of days without nighttime cough; percentage of days without ß-agonist use; percentage of patients without asthma attacks; percentage of patients without corticosteroid rescues.;Primary end point(s): Percentage of days without asthma (A day with all of the following: no daytime symptoms, no nighttime cough, no ß-agonist use, and no asthma attack (defined as a visit to a doctor, urgent care clinic, emergency room, or hospital for asthma [other than a scheduled visit to a doctor] or treatment with systemic or inhaled corticosteroid during the previous 24 hours)	—

Measure

Time frame

Main Objective: E.2.1 Main objective: To demonstrate that montelukast, compared with placebo, improves asthma control (as measured by the percentage of days without asthma ) over a 24-week treatment period in patients aged 6 months to 5 years with chronic asthma. To compare the safety profile of montelukast with placebo over the 24-week treatment period in patients aged 6 months to 5 years with chronic asthma.;Secondary Objective: E.2.2 Secondary objectives: To demonstrate that montelukast, compared with placebo, improves asthma control in patients aged 6 months to 5 years with chronic asthma over a 24-week treatment period as measured by: percentage of days without daytime symptoms; percentage of days without nighttime cough; percentage of days without ß-agonist use; percentage of patients without asthma attacks; percentage of patients without corticosteroid rescues.;Primary end point(s): Percentage of days without asthma (A day with all of the following: no daytime symptoms, no nighttime cough, no ß-agonist use, and no asthma attack (defined as a visit to a doctor, urgent care clinic, emergency room, or hospital for asthma [other than a scheduled visit to a doctor] or treatment with systemic or inhaled corticosteroid during the previous 24 hours)

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Countries

Denmark, Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026