Bronchiolitis
Conditions
Keywords
Bronchiolitis, montelukast, leukotriene inhibitor
Brief summary
The primary rationale for this study is to evaluate the effect of once daily montelukast on duration of acute illness in infants with first-time bronchiolitis.
Interventions
DRUGmontelukast sodium
4mg granules daily for 14 days
OTHERsucrose
table sugar as placebo daily for 14 days
Sponsors
Medical College of Wisconsin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Months to 12 Months
Healthy volunteers
No
Inclusion criteria
* Male or female infants aged 3 to 12 months of age * Diagnosis by emergency physician of bronchiolitis
Exclusion criteria
* Any previous episode, as determined by a physician, of wheezing, bronchiolitis or asthma * Any history of previous bronchodilator use prior to this illness * Treatment with corticosteroids in the 14 days prior to the current illness * Immunosuppression * Immunodeficiency * Caregiver does not speak English * Diagnosis by the treating ED physician of croup * Diagnosis by the treating ED physician of pneumonia * Caregiver does not have access to a telephone
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of Cough | up to 4 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Montelukast 4mg granules
montelukast sodium: 4mg granules daily for 14 days | 60 |
| Sucrose sucrose: table sugar as placebo daily for 14 days | 64 |
| Total | 124 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 8 | 9 |
Baseline characteristics
| Characteristic | Montelukast | Sucrose | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 60 Participants | 64 Participants | 124 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 60 participants | 64 participants | 124 participants |
| Sex: Female, Male Female | 28 Participants | 29 Participants | 57 Participants |
| Sex: Female, Male Male | 32 Participants | 35 Participants | 67 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 68 | 5 / 73 |
| serious Total, serious adverse events | 0 / 68 | 0 / 73 |
Outcome results
Primary
Duration of Cough
Time frame: up to 4 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Montelukast | Duration of Cough | 13 days |
| Placebo | Duration of Cough | 11 days |