Croup
Conditions
Keywords
croup, recurrent croup, barky cough
Brief summary
Presently children who experience recurring croup symptoms receive a variety of treatments. This is because it is not clear which treatments may be best. Some children are given inhaled steroids (similar to what children with asthma use). Others are carefully watched and cautioned to avoid potential triggers (certain foods, environmental allergens, etc), and should episodes of croup recur they are treated with a short course of oral steroids. The purpose of this study is to compare two safe and clinically appropriate methods for treating recurrent croup, daily inhaled steroids versus observation with oral steroids on an as needed basis, to see if either is useful in preventing future episodes of croup.
Interventions
DRUGFluticasone
Daily inhaled steroids. Fluticasone 2 puffs inhaled orally twice daily for six months.
DRUGPrednisolone IF needed
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 15 Years
Healthy volunteers
No
Inclusion criteria
* Pediatric population: 6 months to 15 years of age * 2 or more episodes of croup in 12 month period * croup defined as acute onset inspiratory stridor, barking cough, with respiratory distress.
Exclusion criteria
* Grade 3 or 4 subglottic stenosis * Subglottic hemangioma * Posterior laryngeal cleft * Recurrent respiratory papillomatosis * External compression (Innominate artery compression, mediastinal mass, (double aortic arch, etc) * Symptoms or signs suggesting another cause of stridor, such as epiglottitis, bacterial tracheitis, or supraglottic foreign body * Tracheomalacia/ bronchomalacia severe enough to cause respiratory distress * Current steroid therapy for previously diagnosed condition, i.e. reactive airway disease. * Other medical conditions necessitating chronic steroid utilization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quantity of Recurrent Episodes | 1 year | Quantity of recurrent croup episodes experienced over a 1 year period by each participating subject. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of Croup Episodes | 1 year | Severity of recurrent croup episodes based on Westley Croup scale (0 - 17, where 0 is mildest croup symptoms and 17 is most severe symptoms.) |
Countries
United States
Participant flow
Recruitment details
10 participants were recruited and consented and had their initial baseline bronchoscopy, but of the 5 at 1 site, only 1 had an actual croup episode within he first 6 months. Because of decreased recruitment, the study was terminated. The other site's data is not fully available due to unexpected staff turnover and systems failures.
Participants by arm
| Arm | Count |
|---|---|
| Inhaled Steroids Daily inhaled steroids. Fluticasone 2 puffs inhaled orally twice daily for six months.
Fluticasone: Daily inhaled steroids. Fluticasone 2 puffs inhaled orally twice daily for six months. | 5 |
| Oral Control Short term oral prednisolone. Offered at 1mg/kg daily dosing for symptomatic treatment on as needed basis for three days, but may be modified per managing physician's discretion. | 5 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | no additional croup episodes to evaluate | 2 | 2 |
| Overall Study | participant consented but did not begin | 0 | 1 |
| Overall Study | reasons not available | 3 | 2 |
Baseline characteristics
| Characteristic | Inhaled Steroids | Oral Control | Total |
|---|---|---|---|
| Age, Customized 6 months to 15 years | 5 Participants | 5 Participants | 10 Participants |
| Region of Enrollment United States | 5 Participants | 5 Participants | 10 Participants |
| Sex: Female, Male Female | 0 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 5 | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 |
Outcome results
Primary
Quantity of Recurrent Episodes
Quantity of recurrent croup episodes experienced over a 1 year period by each participating subject.
Time frame: 1 year
Population: No participants completed to 1 year because of early study termination.
Secondary
Severity of Croup Episodes
Severity of recurrent croup episodes based on Westley Croup scale (0 - 17, where 0 is mildest croup symptoms and 17 is most severe symptoms.)
Time frame: 1 year
Population: No participants completed to 1 year because of early study termination.