Management of Recurrent Croup

Study Overview
=================
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.

Official Title
-----------------
Management of Recurrent Croup: Comparison Between Inhaled Fluticasone and Oral Prednisolone

Conditions
-----------------
Croup

Intervention / Treatment
-----------------
* Drug: Fluticasone
* Drug: Prednisolone IF needed


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 15 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inhaled steroids<br>Daily inhaled steroids. Fluticasone 2 puffs inhaled orally twice daily for six months. | Drug: Fluticasone<br>* Daily inhaled steroids. Fluticasone 2 puffs inhaled orally twice daily for six months.<br>|
| Active Comparator: Oral control<br>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<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
croup, recurrent croup, barky cough