Asthma
Conditions
Brief summary
Patients were treated with either montelukast 4 mg oral granules or usual care. Patients who completed Protocol MK0476-176-01 (NCT00943683) had the option to enroll in this study. Additionally, patients with asthma who were 6 to 11 months of age and who had not participated in Protocol MK0476-176-01, could also enroll.
Interventions
DRUGmontelukast sodium
Montelukast 4 mg oral granules mixed with 1 tablespoon soft food once daily at bedtime for 52 weeks
DRUGComparator: Usual Care
Usual care defined as inhaled/nebulized cromolyn or inhaled nedocromil or inhaled/nebulized corticosteroids, according to the investigator's usual clinical practice for 52 weeks
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 2 Years
Healthy volunteers
No
Inclusion criteria
* Patient successfully completed visit 5 of MK0476 Protocol 176 (NCT00943683) OR: * 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 had any major surgery 4 weeks prior * Patient had an allergy to apples or applesauce
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Clinical Adverse Experiences (CAEs) Reported by Patients With up to 52 Weeks of Treatment | Up to 52 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 27 sites in Africa, Europe, North America, and South America Therapy period: May 2001 to Mar 2003.
Pre-assignment details
This was an open-label, controlled extended safety study. Patients were treated with either montelukast 4-mg oral granules or usual care. Patients who completed Protocol 176-01 had the option to enroll in this study. Additionally, patients with asthma who were 6 to 11 months of age and who had not participated in Protocol 176-01, could also enroll.
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Usual care: defined as inhaled/nebulized cromolyn or inhaled nedocromil or inhaled/nebulized corticosteroids, according to the investigator's usual clinical practice for 52 weeks | 32 |
| Montelukast Montelukast 4-mg oral granules mixed with 1 tablespoon soft food once daily at bedtime for 52 weeks. | 158 |
| Total | 190 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 6 |
| Overall Study | Lost to Follow-up | 0 | 4 |
| Overall Study | Protocol Violation | 2 | 5 |
| Overall Study | Site terminated and other | 12 | 56 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Usual Care | Montelukast | Total |
|---|---|---|---|
| Age, Continuous | 16.69 Months STANDARD_DEVIATION 7.22 | 16.45 Months STANDARD_DEVIATION 7.41 | 16.49 Months STANDARD_DEVIATION 7.36 |
| Sex: Female, Male Female | 11 Participants | 45 Participants | 56 Participants |
| Sex: Female, Male Male | 21 Participants | 113 Participants | 134 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 30 / 32 | 155 / 158 |
| serious Total, serious adverse events | 1 / 32 | 15 / 158 |
Outcome results
Primary
Number of Clinical Adverse Experiences (CAEs) Reported by Patients With up to 52 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: Up to 52 weeks of treatment
Population: All patients who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Usual Care | Number of Clinical Adverse Experiences (CAEs) Reported by Patients With up to 52 Weeks of Treatment | With CAEs | 31 Participants |
| Usual Care | Number of Clinical Adverse Experiences (CAEs) Reported by Patients With up to 52 Weeks of Treatment | Without CAEs | 1 Participants |
| Montelukast | Number of Clinical Adverse Experiences (CAEs) Reported by Patients With up to 52 Weeks of Treatment | With CAEs | 156 Participants |
| Montelukast | Number of Clinical Adverse Experiences (CAEs) Reported by Patients With up to 52 Weeks of Treatment | Without CAEs | 2 Participants |