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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inhaled steroids | Experimental | Daily inhaled steroids. Fluticasone 2 puffs inhaled orally twice daily for six months. |
|
| Oral control | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluticasone | Drug | Daily inhaled steroids. Fluticasone 2 puffs inhaled orally twice daily for six months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quantity of Recurrent Episodes | Quantity of recurrent croup episodes experienced over a 1 year period by each participating subject. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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.) | 1 year |
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Inclusion Criteria:
Pediatric population: 6 months to 15 years of age
2 or more episodes of croup in 12 month period
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David J Brown, MD | University of Michigan Department of Otolaryngology-Head & Neck Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| Label | URL |
|---|---|
| Please visit our Department Facebook page for information regarding the study | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Oral Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Age brackets of children participating: |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Quantity of Recurrent Episodes | Quantity of recurrent croup episodes experienced over a 1 year period by each participating subject. | No participants completed to 1 year because of early study termination. | Posted | 1 year |
|
Six months (because study was terminated based on no participants having additional episodes).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David J. Brown | University of Michigan | davidjb@med.umich.edu |
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| ID | Term |
|---|---|
| D003440 | Croup |
| ID | Term |
|---|---|
| D007827 | Laryngitis |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| Prednisolone IF needed | Drug |
|
| reasons not available |
|
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.
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Due to unexpected staff turnover, data from one site is incomplete. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
| 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.) | No participants completed to 1 year because of early study termination. | Posted | 1 year |
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | 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. | 0 | 5 | 0 | 5 |
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| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |