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Management of Recurrent Croup

Primary Purpose

Croup

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Fluticasone
Prednisolone IF needed
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Croup focused on measuring croup, recurrent croup, barky cough

Eligibility Criteria

6 Months - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Inhaled steroids

Oral control

Arm Description

Daily inhaled steroids. Fluticasone 2 puffs inhaled orally twice daily for six months.

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.

Outcomes

Primary Outcome Measures

Quantity of Recurrent Episodes
Quantity of recurrent croup episodes experienced over a 1 year period by each participating subject.

Secondary Outcome Measures

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.)

Full Information

First Posted
October 31, 2012
Last Updated
November 1, 2017
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT01748162
Brief Title
Management of Recurrent Croup
Official Title
Management of Recurrent Croup: Comparison Between Inhaled Fluticasone and Oral Prednisolone
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Terminated
Study Start Date
September 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Croup
Keywords
croup, recurrent croup, barky cough

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inhaled steroids
Arm Type
Experimental
Arm Description
Daily inhaled steroids. Fluticasone 2 puffs inhaled orally twice daily for six months.
Arm Title
Oral control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Fluticasone
Intervention Description
Daily inhaled steroids. Fluticasone 2 puffs inhaled orally twice daily for six months.
Intervention Type
Drug
Intervention Name(s)
Prednisolone IF needed
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David J Brown, MD
Organizational Affiliation
University of Michigan Department of Otolaryngology-Head & Neck Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.facebook.com/MichiganOtolaryngology
Description
Please visit our Department Facebook page for information regarding the study

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Management of Recurrent Croup

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