A Phase 3 interventional study of Fluticasone and Prednisolone IF needed in Croup, sponsored by University of Michigan. Terminated at 1 site in United States. Open to participants aged 6 Months to 15 Years. Per ClinicalTrials.gov, last updated 2017-11-13.
Sponsored by University of Michigan · Phase 3, Interventional, and Treatment
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.
2 or more episodes of croup in 12 month period
Exclusion Criteria:
Daily inhaled steroids. Fluticasone 2 puffs inhaled orally twice daily for six months.
Drug: Fluticasone
Patient and clinician observation with short term oral prednisolone as needed. Offered at 1mg/kg (body weight) daily dosing for symptomatic treatment on as needed basis for three days, but may be modified per managing physician's discretion.
Drug: Prednisolone IF needed
Daily inhaled steroids. Fluticasone 2 puffs inhaled orally twice daily for six months.
Quantity of Recurrent Episodes
Quantity of recurrent croup episodes experienced over a 1 year period by each participating subject.
Time frame: 1 year
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
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.
| Milestone | Inhaled Steroids | Oral Control |
|---|---|---|
| Started | 5 | 5 |
| Started 6 month initial treatment plan | 2 | 2 |
| Completed 6 month initial treatment | 0 | 0 |
| Started 6 month followup | 0 | 0 |
| Completed | 0 | 0 |
| Not completed | 5 | 5 |
| Withdrew: No additional croup episodes to evaluate | 2 | 2 |
| Withdrew: Participant consented but did not begin | 0 | 1 |
| Withdrew: Reasons not available | 3 | 2 |
Quantity of recurrent croup episodes experienced over a 1 year period by each participating subject.
No measurements were reported for this outcome.
Severity of recurrent croup episodes based on Westley Croup scale (0 - 17, where 0 is mildest croup symptoms and 17 is most severe symptoms.)
No measurements were reported for this outcome.
Collected over Six months (because study was terminated based on no participants having additional episodes).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Inhaled Steroids | — | 0/5 (0%) | 0/5 (0%) |
| Oral Control | — | 0/5 (0%) | 0/5 (0%) |
| Age, Customized(Participants) | Inhaled Steroids | Oral Control | Total |
|---|---|---|---|
| 6 months to 15 years | 5 | 5 | 10 |
| Sex: Female, Male(Participants) | Inhaled Steroids | Oral Control | Total |
|---|---|---|---|
| Female | 0 | 2 | 2 |
| Male | 2 | 1 | 3 |
| Region of Enrollment(Participants) | Inhaled Steroids | Oral Control | Total |
|---|---|---|---|
| United States | 5 | 5 | 10 |
This study is terminated, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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University of Michigan