Asthma
Conditions
Brief summary
A study of Montelukast compared to placebo in asthmatic children aged 6-24 months.
Interventions
DRUGmontelukast sodium
Montelukast 4-mg oral granules mixed with applesauce once daily at bedtime for 6 weeks
DRUGComparator: Placebo
Placebo oral granules mixed with applesauce once daily at bedtime for 6 weeks
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Months to 24 Months
Healthy volunteers
No
Inclusion criteria
* Patient is in good, stable health * Patient has been fed solid foods for at least 1 month * Patients had at least 3 episodes of asthma or asthma-like symptoms, all occurring after 8 weeks of age; at least one within 6 months of the Prestudy Visit * Patients had to be in need of a controller therapy according to criteria established in the Global Initiative for Asthma (GINA) guidelines
Exclusion criteria
* Patient was hospitalized at the start of the study or required a visit to the emergency room due to asthma with in past 2 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Clinical Adverse Experiences (CAEs) Reported by Patients During the 6-weeks of Treatment | During the 6 weeks of treatment | An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product |
Participant flow
Recruitment details
Patients were recruited at 65 study centers in Africa, Asia, Europe, North America, and South America Therapy period: Aug 2000 to Feb 2001
Pre-assignment details
Patients had at least 3 episodes of asthma or asthma-like symptoms, all occurring after 8 weeks of age; at least one within 6 months of the Prestudy Visit. Patients had to be in need of a controller therapy according to criteria established in the Global Initiative for Asthma (GINA) guidelines
Participants by arm
| Arm | Count |
|---|---|
| Placebo Montelukast matching placebo oral granules mixed with applesauce once daily at bedtime for 6 weeks | 81 |
| Montelukast Montelukast 4-mg oral granules mixed with applesauce once daily at bedtime for 6 weeks | 175 |
| Total | 256 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 3 |
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Patient Moved | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Placebo | Montelukast | Total |
|---|---|---|---|
| Age, Continuous | 14.05 Months STANDARD_DEVIATION 5.22 | 14.90 Months STANDARD_DEVIATION 4.7 | 14.63 Months STANDARD_DEVIATION 4.87 |
| Sex: Female, Male Female | 22 Participants | 59 Participants | 81 Participants |
| Sex: Female, Male Male | 59 Participants | 116 Participants | 175 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 55 / 81 | 112 / 175 |
| serious Total, serious adverse events | 1 / 81 | 7 / 175 |
Outcome results
Primary
Number of Clinical Adverse Experiences (CAEs) Reported by Patients During the 6-weeks of Treatment
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
Time frame: During the 6 weeks of treatment
Population: All patients who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Clinical Adverse Experiences (CAEs) Reported by Patients During the 6-weeks of Treatment | With CAEs | 62 Participants |
| Placebo | Number of Clinical Adverse Experiences (CAEs) Reported by Patients During the 6-weeks of Treatment | Without CAEs | 19 Participants |
| Montelukast | Number of Clinical Adverse Experiences (CAEs) Reported by Patients During the 6-weeks of Treatment | With CAEs | 132 Participants |
| Montelukast | Number of Clinical Adverse Experiences (CAEs) Reported by Patients During the 6-weeks of Treatment | Without CAEs | 43 Participants |