Management of Recurrent Croup
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Inhaled steroids Daily inhaled steroids. Fluticasone 2 puffs inhaled orally twice daily for six months. |
Drug: Fluticasone
Daily inhaled steroids. Fluticasone 2 puffs inhaled orally twice daily for six months.
|
Active Comparator: Oral control 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
|
Outcome Measures
Primary Outcome Measures
- Quantity of Recurrent Episodes [1 year]
Quantity of recurrent croup episodes experienced over a 1 year period by each participating subject.
Secondary Outcome Measures
- 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.)
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of Michigan | Ann Arbor | Michigan | United States | 48109 |
Sponsors and Collaborators
- University of Michigan
Investigators
- Principal Investigator: David J Brown, MD, University of Michigan Department of Otolaryngology-Head & Neck Surgery
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 00059385
Study Results
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. |
---|---|
Pre-assignment Detail |
Arm/Group Title | Inhaled Steroids | Oral Control |
---|---|---|
Arm/Group Description | 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. | 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. |
Period Title: Overall Study | ||
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 |
Baseline Characteristics
Arm/Group Title | Inhaled Steroids | Oral Control | Total |
---|---|---|---|
Arm/Group Description | 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. | 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. | Total of all reporting groups |
Overall Participants | 5 | 5 | 10 |
Age, Customized (Count of Participants) | |||
6 months to 15 years |
5
100%
|
5
100%
|
10
100%
|
Sex: Female, Male (Count of Participants) | |||
Female |
0
0%
|
2
40%
|
2
20%
|
Male |
2
40%
|
1
20%
|
3
30%
|
Region of Enrollment (Count of Participants) | |||
United States |
5
100%
|
5
100%
|
10
100%
|
Outcome Measures
Title | Quantity of Recurrent Episodes |
---|---|
Description | Quantity of recurrent croup episodes experienced over a 1 year period by each participating subject. |
Time Frame | 1 year |
Outcome Measure Data
Analysis Population Description |
---|
No participants completed to 1 year because of early study termination. |
Arm/Group Title | Inhaled Steroids | Oral Control |
---|---|---|
Arm/Group Description | 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. | 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. |
Measure Participants | 0 | 0 |
Title | Severity of Croup Episodes |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
No participants completed to 1 year because of early study termination. |
Arm/Group Title | Inhaled Steroids | Oral Control |
---|---|---|
Arm/Group Description | 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. | 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. |
Measure Participants | 0 | 0 |
Adverse Events
Time Frame | Six months (because study was terminated based on no participants having additional episodes). | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Inhaled Steroids | Oral Control | ||
Arm/Group Description | 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. | 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. | ||
All Cause Mortality |
||||
Inhaled Steroids | Oral Control | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
Inhaled Steroids | Oral Control | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/5 (0%) | 0/5 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Inhaled Steroids | Oral Control | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/5 (0%) | 0/5 (0%) |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Dr. David J. Brown |
---|---|
Organization | University of Michigan |
Phone | |
davidjb@med.umich.edu |
- 00059385